tag:blogger.com,1999:blog-76275277562292239132024-03-18T00:45:51.581-07:00SkillsPlus International InfoSkillsPlus Intl Inc - FDA, GMP, QSR, Exemptee, and Designated Representative training courses, for more than 30 years.Allan Deweshttp://www.blogger.com/profile/05103525074693242935noreply@blogger.comBlogger347125tag:blogger.com,1999:blog-7627527756229223913.post-72405352781080398522023-08-29T09:50:00.004-07:002023-08-29T09:52:44.181-07:00As Supply Chain Partners Ramp Up For November DSCSA Deadline, US FDA Gives Them Another Year - Pink Sheet<p></p><ul style="text-align: left;"><li>The top choice for FDA GMP QSR cGMP Online Training: <a href="http://www.skillsplusinc.com/CBPresent.htm" target="_blank"><span style="color: #6fa8dc;">FDA cGMP QSR GMP Online Training - popular online training courses</span></a> by SkillsPlus International Inc. #FDA #cGMP #GMP #QSR #training | Recommended | Respected | Popular | The best choice for FDA CGMP online training courses and programs. </li></ul><p></p><p>Read the full text of the source article, so you can be sure about what is included and excluded from the one year delay in enforcement action.</p><p>According to the article:</p><p>"The US Food and Drug Administration has given pharmaceutical distribution trading partners an extra year to comply with package-level Drug Supply Chain Security Act product tracing requirements that take effect 27 November [2023] before it starts enforcing them."</p><p>Source Article: <a href="https://pink.pharmaintelligence.informa.com/PS148764/As-Supply-Chain-Partners-Ramp-Up-For-November-DSCSA-Deadline-US-FDA-Gives-Them-Another-Year" target="_blank"><span style="color: #6fa8dc;">As Supply Chain Partners Ramp Up For November DSCSA Deadline, US FDA Gives Them Another Year - Pink Sheet</span></a></p><p>Go to the FDA Guidance: <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enhanced-drug-distribution-security-requirements-under-section-582g1-federal-food-drug-and-cosmetic" target="_blank"><span style="color: #6fa8dc;">Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act--Compliance Policies - FDA.gov</span></a></p><div class="blogger-post-footer">Call us, SkillsPlus International Inc., at (415) 948-5220 ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
</div>Austin Leehttp://www.blogger.com/profile/02068495179758051574noreply@blogger.com1tag:blogger.com,1999:blog-7627527756229223913.post-33217419842066212562022-08-01T07:50:00.002-07:002023-02-02T09:11:36.092-08:00California Designated Representative 3PL Training Course<p></p><ul style="text-align: left;"><li><a href="https://cvent.me/2KP04G" target="_blank"><span style="color: #6fa8dc;">Learn more | Buy now! - California Designated Representative 3PL Training Course</span></a></li></ul><p></p><h1 style="text-align: left;">California Designated Representative<br />3PL Training</h1><div style="text-align: left;"><span style="font-size: medium;">Online training (approved by the California State Board of Pharmacy) for Designated Representative third-party logistics provider license applicants & their managers</span></div><div style="text-align: left;"><br /></div><div style="text-align: left;"><div>If you are applying for a California Designated Representative license, then you’re also going to need to include <a href="https://sites.google.com/view/california-designated-rep-wiki/training-affidavit" target="_blank"><span style="color: #6fa8dc;">proof of required training (specifically, a training affidavit)</span></a> in your license application packet. Earn a training affidavit by taking any of <a href="https://dreprof.com/training.htm" target="_blank"><span style="color: #6fa8dc;">our California Designated Representative training courses</span></a>.</div><div><br /></div><div><b>About this California Designated Representative 3PL training program</b></div><div><br /></div><div><ul style="text-align: left;"><li>Price: $525 per student</li><li><table cellpadding="0" cellspacing="0" class="tr-caption-container" style="float: right;"><tbody><tr><td style="text-align: center;"><span style="clear: right; margin-bottom: 1em; margin-left: auto; margin-right: auto;"><a href="https://cvent.me/2KP04G" target="_blank"><img alt="California Designated Representative 3PL Training. Online training (approved by the California State Board of Pharmacy) for Designated Representative third-party logistics provider license applicants & their managers." border="0" data-original-height="528" data-original-width="1056" height="100" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhYmAxNhua6Xk5_dMoFIDf_xPQsaDmQg1R-LEFyk5PhZ_cfyPjvTCrpotptVzVBLpmisvZD9HXBd1GU_r-vtMx-xHorjYGr2GUuAg-ta4ur36vgUPuiZjyee5IKBy-_p2cBtKVprJJYSj8w0EqozXb0XURBEHseW5tVDaoy_81y_BWG316lZ61Llww6/w200-h100/2021%2004Apr%20DR%203PL.png" title="California Designated Representative 3PL Training. Online training (approved by the California State Board of Pharmacy) for Designated Representative third-party logistics provider license applicants & their managers." width="200" /></a></span></td></tr><tr><td class="tr-caption" style="text-align: center;"><a href="https://cvent.me/2KP04G" target="_blank"><span style="color: #6fa8dc;">Calif Des Rep 3PL Training</span></a></td></tr></tbody></table>Enter our online classroom to take the course. Available 24 x 7.</li><li>This course is approved by the <a href="https://www.pharmacy.ca.gov/" target="_blank"><span style="color: #6fa8dc;">California State Board of Pharmacy</span></a>.</li><li>The course covers all required topics specified in the Board's license application.</li><li>Successful course completion earns a training affidavit accepted by the Board.</li><li>More than 7,500 students trained!</li></ul></div><div><br /></div><div><b>Take action!</b></div><div><a href="https://cvent.me/2KP04G" target="_blank"><span style="color: #6fa8dc;">Learn more | Buy now! <br /></span></a></div><div><br /></div><div><b>About the Designated Representative 3PL License</b>:</div><div><a href="https://www.pharmacy.ca.gov/applicants/desig_rep_3pl.shtml" target="_blank"><span style="color: #6fa8dc;">California Designated Representative 3PL License - California Board of Pharmacy</span></a></div></div><p><span style="color: #073763;">#CaliforniaDesRep #CaliforniaDesignatedRepresentative</span></p><div class="blogger-post-footer">Call us, SkillsPlus International Inc., at (415) 948-5220 ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
</div>Austin Leehttp://www.blogger.com/profile/02068495179758051574noreply@blogger.com3tag:blogger.com,1999:blog-7627527756229223913.post-19817242026805270612022-06-29T09:40:00.003-07:002022-06-29T09:40:41.420-07:00DRUG FRAUD ALERT: DISTRIBUTOR/CUSTOMER PRODUCT ORDERING SCHEME<p></p><ul style="text-align: left;"><li><a href="https://cvent.me/VnkZL8" target="_blank"><span style="color: #6fa8dc;">Trusted Board-approved California Designated Representative online training programs for wholesaler, 3PL, and reverse distributor license applicants. Learn more & buy.</span></a></li></ul><p></p><p>"Since December 2020, there have been reports of both distributors as well as several of their pharmacy customers receiving telephone calls and/or emails as part of a sophisticated “phishing” scam to unlawfully divert pharmaceutical goods in transit."</p><p>"RECOMMENDED ACTIONS TO PROTECT DISTRIBUTORS: RISK MITIGATION</p><p>There are several ways to validate correspondences with what appear to be legitimate distributor customers: ... "</p><p>Go to the following source document to view the complete list of recommended actions.</p><p>Source: <a href="https://www.hdapcsc.org/~/media/pdfs/pcsc/resource-library/pcsc-fraud-alert-product-ordering-scheme.ashx?la=en" target="_blank"><span style="color: #6fa8dc;">FRAUD ALERT: DISTRIBUTOR/CUSTOMER PRODUCT ORDERING SCHEME Version 2 (Updated June 2022) - HDAPCSC (PDF)</span></a></p><p style="text-align: center;">- - -</p><p><br /></p>
<h3>
For Designated Representative license applicants - Training programs, courses, classes, seminars:</h3>
<b>California</b> (earn a training affidavit):<br />
<ul>
<li><span><span><a href="https://cvent.me/VnkZL8" target="_blank"><span style="color: #6fa8dc;">CA Designated Representative Wholesaler Training</span></a><span style="color: brown;"> </span></span></span></li>
<li><a href="https://cvent.me/2KP04G" target="_blank"><span style="color: #6fa8dc;">CA Designated Representative 3PL Training</span></a></li><li><a href="https://cvent.me/wQzd9m" target="_blank"><span style="color: #6fa8dc;">CA Designated Representative Reverse Distributor Training</span></a><span style="color: red;"> </span></li><li><a href="http://www.desrep.org/" target="_blank"><span style="color: #6fa8dc;">The Designated Representative Institute</span></a></li></ul>
<b>Florida</b>:<br />
<ul>
<li><a href="https://cdrresourcecenter.com/web/site/online-testing-and-training" target="_blank"><span style="color: #6fa8dc;">Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course</span></a></li>
</ul>
<br />
<h3>
For HMDR Exemptee license applicants - Training programs, courses, classes, seminars:</h3>
<b>California </b>(earn a training completion certificate):<br />
<ul>
<li><a href="https://cvent.me/OmKRnG" target="_blank"><span style="color: #6fa8dc;">CA Home Medical Device Retailer (HMDR) Exemptee Training Course</span></a></li><li><a href="http://www.exemptee.org/" target="_blank"><span style="color: #6fa8dc;">The Exemptee Institute</span></a></li></ul>
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</div>Austin Leehttp://www.blogger.com/profile/02068495179758051574noreply@blogger.com0tag:blogger.com,1999:blog-7627527756229223913.post-72881131339995225462022-04-26T04:31:00.001-07:002022-04-26T04:31:30.387-07:00Drug Products, Including Biological Products, that Contain Nanomaterials - Final Guidance Document<p></p><ul style="text-align: left;"><li><a href="https://gmpprof.com/" target="_blank"><span style="color: #6fa8dc;">Trusted FDA cGMP online training programs and courses by SkillsPlus International Inc</span></a>.</li></ul><p></p><p>According to the final guidance document: </p><p>"Nanotechnology can be used in a broad array of FDA-regulated products, such as human drug products, including those that are biological products. Nanotechnology may be used to create drug products in which nanomaterials (as explained in section II of this document), serve a variety of functions, as active ingredient or inactive ingredients, including carriers loaded with an active ingredient. The inclusion of such materials may result in product attributes that differ from those of products that do not contain such materials, and thus may merit particular examination. This document provides guidance on the development of human drug products, including those that are biological products, in which a nanomaterial is present in the finished dosage form."</p><p>Reference: <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/drug-products-including-biological-products-contain-nanomaterials-guidance-industry" target="_blank"><span style="color: #6fa8dc;">Drug Products, Including Biological Products, that Contain Nanomaterials - Final Guidance for Industry - FDA.gov</span></a></p><p><a href="http://www.skillsplusinfo.blogspot.com/"><span style="color: #6fa8dc;">Return to SkillsPlus International Info Blog - Home</span></a></p><p style="text-align: center;">- - -</p>
<span style="color: #6fa8dc;"><a href="http://www.skillsplusinc.com/"><span style="color: #6fa8dc;">SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around</span></a><br />
<a href="http://www.skillsplusinc.com/root_cause.htm"><span style="color: #6fa8dc;">Root Cause Analysis - GMP Training</span></a><br />
<a href="http://www.skillsplusinc.com/reports.htm"><span style="color: #6fa8dc;">Deviation Investigation Report Writing - GMP Training</span></a></span><br /><br /><div class="blogger-post-footer">Call us, SkillsPlus International Inc., at (415) 948-5220 ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
</div>Austin Leehttp://www.blogger.com/profile/02068495179758051574noreply@blogger.com0tag:blogger.com,1999:blog-7627527756229223913.post-76363268278807091742022-04-18T17:07:00.003-07:002022-04-18T17:07:45.583-07:00FDA proposes to rate pharmaceutical manufacturing facilities - RAPS<p></p><ul style="text-align: left;"><li><a href="https://gmpprof.com/" target="_blank"><span style="color: #6fa8dc;">Trusted FDA cGMP online training programs and courses taught by SkillsPlus International Inc</span></a>. </li></ul><p></p><p>According to the article:</p><p>"The US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality has proposed the development of a rating system to measure a firm’s quality management maturity (QMM) as a way to mitigate drugs shortages and enhance the quality of finished drug products, according to a new white paper. The ratings would be publicly available."</p><p>Read the full source article: <a href="https://www.raps.org/news-and-articles/news-articles/2022/4/fda-proposes-to-rate-pharmaceutical-manufacturing" target="_blank"><span style="color: #6fa8dc;">FDA proposes to rate pharmaceutical manufacturing facilities - RAPS</span></a></p><p>Go to the white paper referenced above, <a href="https://www.fda.gov/media/157432/download?utm_medium=email&utm_source=govdelivery" target="_blank"><span style="color: #6fa8dc;">CENTER FOR DRUG EVALUATION AND RESEARCH (CDER) - An Office of Pharmaceutical Quality (OPQ) White Paper - Quality Management Maturity: Essential for Stable U.S. Supply Chains of Quality Pharmaceuticals </span></a></p><div class="blogger-post-footer">Call us, SkillsPlus International Inc., at (415) 948-5220 ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
</div>Austin Leehttp://www.blogger.com/profile/02068495179758051574noreply@blogger.com0tag:blogger.com,1999:blog-7627527756229223913.post-12826212770910185692022-01-01T10:45:00.008-08:002024-02-06T06:00:22.853-08:00California Designated Representative Training Courses<p>Start your new year training now! SkillsPlus International Inc. is the ONLY Board-approved provider of all three (3) of the following training programs. Enroll now in any one of our Board-approved California Designated Representative training courses to earn a training affidavit for your license application:</p><p></p><ul>
<li><a href="https://cvent.me/VnkZL8" target="_blank"><span style="color: #6fa8dc;">Wholesaler Training Course</span></a></li>
<li><a href="https://cvent.me/2KP04G" target="_blank"><span style="color: #6fa8dc;">3PL Training Course</span></a></li>
<li><a href="https://cvent.me/wQzd9m" target="_blank"><span style="color: #6fa8dc;">Reverse Distributor Training Course</span></a></li>
</ul><h3 style="text-align: left;">California Designated Representative Training Courses</h3><div><div><br /></div><div>Don't get caught flat-footed in the new year! </div></div><div><br /></div><div><h3 style="text-align: left;">More Than 7,500 Students Have Taken Our Courses!</h3><div><br /></div><div>Here's why our online training programs are so popular and highly recommended:</div></div><div><ul style="text-align: left;"><li>These online training courses are designed for California Designated Representative license applicants and their managers. We make the messy regulatory requirements simple and easy to understand!</li><li>Earn a Board-accepted training affidavit, for your license application, by taking any one of our courses.</li><li>No need to schedule your training. Buy the course. Start when you’re ready! Therefore, buy now and start studying!</li><li>Online internet-based e-learning, easily accessed to make it possible & convenient for you to study from your home or office, in other words, study in any location!</li><li>Our courses involve more than just reading slides.</li><li>Available 365 x 24 x 7. Come and go as needed. In other words, our courses are convenient and flexible.</li><li>Composed of a series of self-study pre-recorded presentations that cover essential and required topics (as specified on their respective California Designated Representative license application form).</li><li>Designed with a follow-up quiz after each course section. When you finish, you will request your completion documents, specifically, your training affidavit.</li><li>We’ve added something new, closed captioning. Students can read what the course instructor is teaching. This feature helps ESL (English as a second language) students, and hard of hearing students. Therefore, our courses are more accessible.</li><li>Offered continuously since 2002. Therefore, we have a long record of experience.</li></ul><br /></div><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><span style="margin-left: auto; margin-right: auto;"><a href="https://dreprof.com/buy-now/" target="_blank"><img border="0" data-original-height="720" data-original-width="960" height="300" src="https://blogger.googleusercontent.com/img/a/AVvXsEgftnktFOEj_V48Cv2FhDwtEaFm0IrZSOan2sm3Ic8UcZdW0IBbi508TaEt4aMDbc5Ut2s1LMMex748VtR300mceuZrH_yDOAY_6CKAzKTj3T2ijYDzcxsPyHYe-V099bC5uR5fZtfy4VrCry_L8SWXX8gSpnWIryZ9MSvomPvkKxMXg89NLHlP_SLm=w400-h300" width="400" /></a></span></td></tr><tr><td class="tr-caption" style="text-align: center;"><a href="https://dreprof.com/buy-now/" target="_blank"><span style="color: #6fa8dc;">Don't get caught flat-footed in the new year! California Designated Representative online training courses by SkillsPlus International Inc.</span></a></td></tr></tbody></table><br /><div style="text-align: center;">- - -</div><div><br /><div>Keywords & Phrases: wholesaler, 3PL, third-party logistics provider, reverse distributor, Board of Pharmacy, 2024, 2025, pharmacy law, rules and regulations</div><div><br /></div><div><br /></div><p></p></div><div class="blogger-post-footer">Call us, SkillsPlus International Inc., at (415) 948-5220 ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
</div>Austin Leehttp://www.blogger.com/profile/02068495179758051574noreply@blogger.com3tag:blogger.com,1999:blog-7627527756229223913.post-52986569688740475972022-01-01T04:56:00.000-08:002022-01-01T04:56:09.762-08:00Jennifer Payne Named President Of SkillsPlus Intl Inc.<table cellpadding="0" cellspacing="0" class="tr-caption-container" style="float: right;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/a/AVvXsEjKDpWLix_VZEWPtDbSiqCP4FkZF2BKqusLIaUnVfUqCnmhyt83TeYEMGezKnU6PVRTZ3d91X3kkfIvnjGotPug2Pi7-wR5Yt8A4Cp58rAeSZ3Bv6DLnv4jYrdRGWTm8XXLzhYFDVTjpVz8vycgxI8cN6GYuB8gXZ-kPKtDZ9Th4f-NI2zIu6ugV4jR=s300" imageanchor="1" style="clear: right; margin-bottom: 1em; margin-left: auto; margin-right: auto; text-align: center;"><img alt="Jennifer Payne Named President Of SkillsPlus International Inc. - Image of Jennifer Payne" border="0" data-original-height="300" data-original-width="200" height="200" src="https://blogger.googleusercontent.com/img/a/AVvXsEjKDpWLix_VZEWPtDbSiqCP4FkZF2BKqusLIaUnVfUqCnmhyt83TeYEMGezKnU6PVRTZ3d91X3kkfIvnjGotPug2Pi7-wR5Yt8A4Cp58rAeSZ3Bv6DLnv4jYrdRGWTm8XXLzhYFDVTjpVz8vycgxI8cN6GYuB8gXZ-kPKtDZ9Th4f-NI2zIu6ugV4jR=w133-h200" title="Jennifer Payne - President, SkillsPlus Intl Inc." width="133" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Jennifer Payne - President<br />SkillsPlus Intl Inc.<br /><br /></td></tr></tbody></table><p>SkillsPlus International Inc. announces its new president, Jennifer Payne. She has been in the education field for 15 years. For the past 5 years, she has been responsible for: handling client California Designated Representative & Exemptee training documentation needs, assuring that program content reflects the most current regulatory requirements, the development & updates to content presentations & quizzes, and assisting with improving company procedures to streamline processes that ensure maximum customer service responsiveness. In her new role she also assumes responsibility for all administrative needs and for managing CGMP contract trainers.</p><p>Mrs. Payne earned a Bachelor Degree in Education with a minor in Spanish, and a Master of Education, both from the University of North Carolina at Greensboro. Similarly, her graduate research included: how psychology affects student learning; effective and reliable test construction; and statistical analyses of teaching techniques.</p><p>Allan Dewes, founder and outgoing president of SkillsPlus International Inc. says, "I founded SkillsPlus International Inc. thirty years ago. At that time, my goal was to provide quality and affordable training services to the pharmaceutical & allied industries. Now, my goal is to turn over the reins of the company to the next generation, promote a new vision, and reshape directions. I will remain a consultant to the president on technical & content issues, and advise on specific online course revisions as the need arises."</p><h3 style="text-align: left;">About SkillsPlus International Inc.</h3><p>SkillsPlus International Inc., was incorporated in 1991. We offer training services to pharmaceutical & medical device manufacturers, California Designated Representatives, and California Home Medical Device Retailers & Exemptees.</p><p>For more information, visit: <a href="https://skillsplusinc.com/ " target="_blank"><span style="color: #6fa8dc;">https://skillsplusinc.com/ </span></a></p><p>Contact: <a href="https://skillsplusinc.com/contact-us/" target="_blank"><span style="color: #6fa8dc;">https://skillsplusinc.com/contact-us/</span></a></p><div><br /></div><div class="blogger-post-footer">Call us, SkillsPlus International Inc., at (415) 948-5220 ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
</div>Austin Leehttp://www.blogger.com/profile/02068495179758051574noreply@blogger.com1tag:blogger.com,1999:blog-7627527756229223913.post-3216901585508391712021-12-30T09:05:00.001-08:002021-12-30T09:05:41.273-08:00The Best FDA CGMP Training<p></p><ul style="text-align: left;"><li><a href="https://gmpprof.com/" target="_blank"><span style="color: #6fa8dc;">Recommended FDA GMP online training courses and programs by SkillsPlus International Inc</span></a>. </li></ul><p></p><h3 style="text-align: left;">Respected FDA GMP Online Training Courses & Programs</h3><p><a href="https://skillsplusinc.com/" target="_blank"><span style="color: #6fa8dc;">SkillsPlus International Inc</span></a>., was incorporated in 1991. We offer training services to pharmaceutical and medical device manufacturers.</p><p>Initially, we offered live training at client plant sites. Consequently, we traveled all over the world teaching the CGMP regulations. Now as a result of high travel expenses, the risk of COVID-19 exposure, and demanding production schedules, we now only offer our CGMP training online. Our training courses with The GMP Professor are designed by course developers with over 40 years of CGMP experience. Furthermore, our company brings to those courses many commonly applied industry practices that may apply to your site as well.</p><p><a href="https://gmpprof.com/" target="_blank"><span style="color: #6fa8dc;">Learn more about our basic and advanced GMP online training courses</span></a>.</p><p style="text-align: center;">- - -</p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><span style="margin-left: auto; margin-right: auto;"><a href="https://skillsplusinc.com/cgmp-online-training-courses/" target="_blank"><img alt="Trusted FDA GMP Online Training Courses & Programs - Image of pharmaceutical glass containers" border="0" data-original-height="720" data-original-width="960" height="300" src="https://blogger.googleusercontent.com/img/a/AVvXsEhxC15xLwS0dCukg3EzXq3KyRHl-2smBMqM3AOZDH9-kihH10YU2QKjkukR39It6ePkMJ4zCw8cWeWCTsXo7Vyc5re2ij5PD-6EPEDuJc4zd9g-ZEWPQrW1HEz21RkMO6hRQ8Iy4UpDpzGMDpEtnTF_nnOqe0azdhTJmifJeK7_yZbAHHeZASPCodIG=w400-h300" title="The Best FDA GMP Online Training Courses & Programs" width="400" /></a></span></td></tr><tr><td class="tr-caption" style="text-align: center;"><a href="https://skillsplusinc.com/cgmp-online-training-courses/" target="_blank"><span style="color: #6fa8dc;">The Best FDA GMP Online Training Courses & Programs</span></a></td></tr></tbody></table><br />#FDA #CGMP #GMP best top choice place recommended respected trusted training<br /><br /><p><br /></p><div class="blogger-post-footer">Call us, SkillsPlus International Inc., at (415) 948-5220 ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
</div>Austin Leehttp://www.blogger.com/profile/02068495179758051574noreply@blogger.com0tag:blogger.com,1999:blog-7627527756229223913.post-69790163247352239812021-12-13T07:48:00.004-08:002023-03-02T04:33:21.671-08:00California Designated Representative Training Course For 3PL (third-party logistics providers)<p></p><ul style="text-align: left;"><li>Sign-up now! California Designated Representative training course for:<br /> <a href="https://cvent.me/2KP04G" target="_blank"><span style="color: #6fa8dc;"> 3PL</span></a> | <a href="https://cvent.me/VnkZL8" target="_blank"><span style="color: #6fa8dc;">Wholesalers</span></a> | <a href="https://cvent.me/wQzd9m" target="_blank"><span style="color: #6fa8dc;">Reverse Distributors</span></a> </li></ul><blockquote style="border: none; margin: 0px 0px 0px 40px; padding: 0px;"><blockquote style="border: none; margin: 0px 0px 0px 40px; padding: 0px; text-align: left;"></blockquote></blockquote><blockquote style="border: none; margin: 0px 0px 0px 40px; padding: 0px;"><blockquote style="border: none; margin: 0px 0px 0px 40px; padding: 0px; text-align: left;"></blockquote></blockquote><p></p><h3 style="text-align: left;">California Designated Representative Training Course For Third-Party Logistics Providers (3PL)</h3><p>The Designated Representative-3PL protects the public health and safety in the handling, storage, warehousing, distribution, and shipment of dangerous drugs and dangerous devices in the third-party logistics provider’s place of business.</p><p>If you are applying for a California Designated Representative license, then you’re also going to need to include proof of required training (specifically, a training affidavit) in your license application packet. Earn a training affidavit by taking any of our California Designated Representative training courses.</p><p></p><blockquote>State-approved by the California State Board of Pharmacy. More than 7,500 students have taken one of our state license-related training classes!</blockquote><p></p><p>This course covers all topics specified on the California Designated Representative 3PL license application form.</p><p><a href="https://desrep.org/third-party-logistics-provider-3pl/" target="_blank"><span style="color: #6fa8dc;">California Designated Representative Training Course For 3PL - Learn more >></span></a></p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><span style="margin-left: auto; margin-right: auto;"><a href="https://cvent.me/2KP04G" target="_blank"><img alt="California Designated Representative Training Course For Third-Party Logistics Providers (3PL). Image of backlit palm trees at sunset on a California ocean beach." border="0" data-original-height="720" data-original-width="960" height="300" src="https://blogger.googleusercontent.com/img/a/AVvXsEh_GwHr6QHy9ftv02oQcQzhV5kUFtHkXKZqMgB6BxIOAoQvPzlKFiEPG3mSw9IjKTIsNPXAcks4o73OrlJEcUuKnKmP0ichShiC9pjJNKveIC9hIdsxy0l10pXJjFY-curaN5YYY983ToT_F6dr-OjL3iYOopuOIABRssRk6gVvV5TWFuTRQNK7bIlI=w400-h300" title="California Designated Representative Training Course For Third-Party Logistics Providers (3PL)" width="400" /></a></span></td></tr><tr><td class="tr-caption" style="text-align: center;"><a href="https://cvent.me/2KP04G" target="_blank"><span style="color: #6fa8dc;">California Designated Representative Training Course For 3PL (third-party logistics providers).<br />Enroll now!</span></a></td></tr></tbody></table><br />#CaliforniaDesRep #CaliforniaDesignatedRepresentative<div class="blogger-post-footer">Call us, SkillsPlus International Inc., at (415) 948-5220 ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
</div>Austin Leehttp://www.blogger.com/profile/02068495179758051574noreply@blogger.com6tag:blogger.com,1999:blog-7627527756229223913.post-18953632491127082482021-11-19T07:31:00.000-08:002021-11-19T07:31:53.571-08:00Will Labor Requirements Increase in Meeting DSCSA Milestones? - HealthcarePackaging.com<p></p><ul style="text-align: left;"><li>Recommended online training courses and programs:</li><ul><li>California Board-approved Designated Representative training for:<br /> <a href="https://cvent.me/VnkZL8" target="_blank"><span style="color: #6fa8dc;">Wholesalers</span></a> | <a href="https://cvent.me/2KP04G" target="_blank"><span style="color: #6fa8dc;">3PL</span></a> | <a href="https://cvent.me/wQzd9m" target="_blank"><span style="color: #6fa8dc;">Reverse Distributors</span></a></li><li><a href="https://gmpprof.com/" target="_blank"><span style="color: #6fa8dc;">FDA cGMP training by SkillsPlus International Inc</span></a>. </li></ul></ul><p></p><p>According to the article:</p><p>"With many companies either facing or concerned about labor shortages in manufacturing, an expert from Cardinal Health notes that outbound scanning alone may require a 12 to 15% increase in headcount in their operations."</p><p>... "she noted. “That outbound scanning is expected to increase labor by a minimum of 12 to 15% based on recent time studies. As an example, a distribution center with a 50-person night crew will need to hire six additional people just to support the outbound scanning.”"</p><p>Read the full source article: <a href="https://www.healthcarepackaging.com/issues/traceability-serialization/article/21821526/will-dscsa-increase-labor-requirements-in-nov-2023" target="_blank"><span style="color: #6fa8dc;">Will Labor Requirements Increase in Meeting DSCSA Milestones? - HealthcarePackaging.com</span></a></p><p style="text-align: center;">- - -</p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEixHvY7p5AGqOwbiqT9UgJdPvyRRGN5v7VdcBmbt8vCd0Cr1WR5AhOvGmtFLQX5_TWrYVwrkv_MefMhn-b1wF2NHISFzRfVdr9kHBI0W15NsfIqz6VkwgzI2DOT-G729ShmWDWN8nqOfkk/s960/2019+08Aug+Blue+Med.png" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img alt="California Board-approved Designated Representative training for: Wholesalers | 3PL | Reverse Distributors" border="0" data-original-height="960" data-original-width="720" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEixHvY7p5AGqOwbiqT9UgJdPvyRRGN5v7VdcBmbt8vCd0Cr1WR5AhOvGmtFLQX5_TWrYVwrkv_MefMhn-b1wF2NHISFzRfVdr9kHBI0W15NsfIqz6VkwgzI2DOT-G729ShmWDWN8nqOfkk/w300-h400/2019+08Aug+Blue+Med.png" title="California Board-approved Designated Representative training for: Wholesalers | 3PL | Reverse Distributors" width="300" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">California Board-approved Designated Representative training for: <br /><a href="https://cvent.me/VnkZL8" target="_blank"><span style="color: #6fa8dc;">Wholesalers</span></a> | <a href="https://cvent.me/2KP04G" target="_blank"><span style="color: #6fa8dc;">3PL</span></a> | <a href="https://cvent.me/wQzd9m" target="_blank"><span style="color: #6fa8dc;">Reverse Distributors</span></a></td></tr></tbody></table><br />#CaliforniaDesignatedRepresentative #CaliforniaDesRep<br /><p><br /></p><div class="blogger-post-footer">Call us, SkillsPlus International Inc., at (415) 948-5220 ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
</div>Austin Leehttp://www.blogger.com/profile/02068495179758051574noreply@blogger.com0tag:blogger.com,1999:blog-7627527756229223913.post-5257798791184692512021-11-13T05:56:00.002-08:002021-11-13T05:57:01.951-08:00Biden nominates Califf as FDA commissioner - RAPS.org<p></p><ul style="text-align: left;"><li><a href="https://gmpprof.com/" target="_blank"><span style="color: #6fa8dc;">Respected FDA CGMP online training courses and programs by SkillsPlus International Inc</span></a>.</li></ul><p></p><p>According to the article:</p><p>"After months of speculation – and just days before a statutory deadline – President Joe Biden on Friday announced he would nominate Robert Califf to serve as Commissioner of Food and Drugs for the second time."</p><p>"Steven Grossman, executive director of the Alliance for a Stronger FDA, told Focus he expects Califf will enter the agency with a more pronounced mandate this time around and "act more resolutely" as a commissioner in the first year of a presidency, compared to his previous stint as commissioner in the final year of the Obama administration.</p><p>"I believe Dr. Califf’s priorities will have a common theme: FDA modernization. To achieve the greatest benefit for the American people, FDA needs the resources and tools to address acceleration of medical progress and the potential for a dramatically safer food supply. He will, I predict, advocate for data and technology modernization, improved means of recruiting and retaining FDA employees, facilities upgrades, and the means to make the agency’s processes more efficient, accurate, and responsive," Grossman said."</p><p>Read the full source article: <a href="https://www.raps.org/news-and-articles/news-articles/2021/11/biden-nominates-califf-as-fda-commissioner" target="_blank"><span style="color: #6fa8dc;">Biden nominates Califf as FDA commissioner - RAPS.org</span></a></p><div class="blogger-post-footer">Call us, SkillsPlus International Inc., at (415) 948-5220 ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
</div>Austin Leehttp://www.blogger.com/profile/02068495179758051574noreply@blogger.com2tag:blogger.com,1999:blog-7627527756229223913.post-27930185279334763072021-10-27T06:19:00.001-07:002021-10-27T06:19:18.976-07:00The Latest Activities Related To The DSCSA - FDA Website<p></p><ul style="text-align: left;"><li>California Designated Representative training courses for: <br /> <a href="https://cvent.me/VnkZL8" target="_blank"><span style="color: #6fa8dc;">Wholesalers</span></a> | <a href="https://cvent.me/2KP04G" target="_blank"><span style="color: #6fa8dc;">3PL</span></a> | <a href="https://cvent.me/wQzd9m" target="_blank"><span style="color: #6fa8dc;">Reverse Distributors</span></a></li><li><a href="https://gmpprof.com/" target="_blank"><span style="color: #6fa8dc;">Recommended FDA CGMP online training courses and programs by SkillsPlus International Inc</span></a>. </li></ul><p></p><h3 style="text-align: left;">Latest Activity - Drug Supply Chain Security Act (DSCSA)</h3><p>I like how the FDA is listing and reporting activity related to the DSCSA. They're now providing links to pertinent activities in a section called "Latest Activity."</p><p>According to the referenced FDA webpage:</p><p>"The Drug Quality and Security Act (DQSA), was enacted by Congress on November 27, 2013. Title II of DQSA, the Drug Supply Chain Security Act (DSCSA), outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. This will enhance FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. The system will also improve detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers.</p><p>Additionally, the DSCSA directs FDA to establish national licensure standards for wholesale distributors and third-party logistics providers, and requires these entities report licensure and other information to FDA annually."</p><p>Go to: <a href="https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa" target="_blank"><span style="color: #6fa8dc;">Drug Supply Chain Security Act (DSCSA) - FDA.gov</span></a></p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjhKLwMkdAR0v7D0_0F0d4oXxuBrQLJCCdHv8paYOJOB1DCUL-ElroXEA5b1cphpcz1DhZKq8uGbIodI3K9PIbtPvIwLl1RlrIhCjG7jFEay1Z_USaoWnrqmbqJH8W3DwSyfvXQZ6meV28/s1280/2018+05+Pin+Collage.png" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img alt="SkillsPlus International Inc. - The leader in compliance training. Collage of pharmaceutical images." border="0" data-original-height="720" data-original-width="1280" height="225" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjhKLwMkdAR0v7D0_0F0d4oXxuBrQLJCCdHv8paYOJOB1DCUL-ElroXEA5b1cphpcz1DhZKq8uGbIodI3K9PIbtPvIwLl1RlrIhCjG7jFEay1Z_USaoWnrqmbqJH8W3DwSyfvXQZ6meV28/w400-h225/2018+05+Pin+Collage.png" title="SkillsPlus International Inc. - The leader in compliance training." width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><a href="https://skillsplusinc.com/" target="_blank"><span style="color: #6fa8dc;">SkillsPlus International Inc. - The leader in compliance training. <br />Learn more about our online training courses and programs</span></a>.</td></tr></tbody></table><div class="blogger-post-footer">Call us, SkillsPlus International Inc., at (415) 948-5220 ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
</div>Austin Leehttp://www.blogger.com/profile/02068495179758051574noreply@blogger.com1tag:blogger.com,1999:blog-7627527756229223913.post-34214235269949752952021-10-15T06:39:00.003-07:002021-10-15T06:39:49.133-07:00Former Obama FDA Chief Califf Is Front-Runner to Lead Agency - Bloomberg<p></p><ul style="text-align: left;"><li><a href="https://gmpprof.com/" target="_blank"><span style="color: #6fa8dc;">Respected FDA GMP online training courses and programs offered by SkillsPlus Intl Inc</span></a>. </li></ul><p></p><p>According to the article:</p><p>"Robert Califf, who ran the U.S. Food and Drug Administration under President Barack Obama, has moved into top contention to lead the agency again, according to people familiar with the matter.</p><p>While a decision isn’t final, Califf is now the front-runner, said the people, who asked not to be identified because nothing has been announced. Califf, who is currently head of clinical strategy and policy at Alphabet Inc.’s Verily and Google Health units, would replace acting FDA Commissioner Janet Woodcock if he is confirmed by the Senate."</p><p>Read the full source article: <a href="https://www.bloomberg.com/news/articles/2021-10-14/former-obama-fda-chief-califf-is-top-contender-to-lead-agency?srnd=markets-vp" target="_blank"><span style="color: #6fa8dc;">Former Obama FDA Chief Califf Is Front-Runner to Lead Agency - Bloomberg</span></a></p><div class="blogger-post-footer">Call us, SkillsPlus International Inc., at (415) 948-5220 ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
</div>Austin Leehttp://www.blogger.com/profile/02068495179758051574noreply@blogger.com1tag:blogger.com,1999:blog-7627527756229223913.post-44009930147653048112021-09-28T08:02:00.002-07:002021-09-28T08:02:41.372-07:00Halloween Safety Tips: Costumes, Candy, and Colored Contact Lenses - FDA.gov<p></p><ul style="text-align: left;"><li><a href="https://gmpprof.com/" target="_blank"><span style="color: #6fa8dc;">Respected FDA GMP online training programs and courses taught by SkillsPlus International Inc</span></a>. </li></ul><p></p><p>According to the FDA: </p><p>"Enjoy a safe and happy Halloween by following these guidelines.</p><p>Halloween is fast approaching, and you and your kids may be celebrating it a bit differently this year. Whatever form your celebration takes, make sure it includes safe hygiene practices such as covering your mouth and nose with a cloth face covering or mask when around others, maintaining social distance and frequent hand washing. The Centers for Disease Control also have tips for protecting yourself and others.<br /></p><p>Whether you’re a ghost or zombie, vampire or witch, poor costume choices—including decorative (colored) contact lenses and flammable costumes—and face paint allergies can cause injuries that haunt you long after Halloween.</p><p></p><div class="separator" style="clear: both; text-align: center;"><a href="https://www.fda.gov/files/styles/landscape_16_9_400_x_225/public/candy-corn-1600x900.png?itok=lRPfOUXE" style="clear: right; float: right; margin-bottom: 1em; margin-left: 1em;"><img border="0" data-original-height="225" data-original-width="400" height="113" src="https://www.fda.gov/files/styles/landscape_16_9_400_x_225/public/candy-corn-1600x900.png?itok=lRPfOUXE" width="200" /></a></div>Enjoy a safe and happy Halloween by following these guidelines from FDA, the Consumer Product Safety Commission, and the Centers for Disease Control and Prevention:" ...<p></p><p>Source Article: <a href="https://www.fda.gov/consumers/consumer-updates/halloween-safety-tips-costumes-candy-and-colored-contact-lenses" target="_blank"><span style="color: #6fa8dc;">Halloween Safety Tips: Costumes, Candy, and Colored Contact Lenses - FDA.gov</span></a></p><p><a href="http://www.skillsplusinfo.blogspot.com/" target="_blank"><span style="color: #6fa8dc;">Return to SkillsPlus International Info Blog - Home</span></a></p><div class="blogger-post-footer">Call us, SkillsPlus International Inc., at (415) 948-5220 ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
</div>Austin Leehttp://www.blogger.com/profile/02068495179758051574noreply@blogger.com1tag:blogger.com,1999:blog-7627527756229223913.post-18607307110285048192021-08-19T07:17:00.004-07:002021-11-11T10:50:51.550-08:00California Designated Representative Training Course<ul style="text-align: left;">
<li><a href="https://cvent.me/VnkZL8" target="_blank"><span style="color: #6fa8dc;">Register now for California Board of Pharmacy Designated Representative Wholesaler Training Course - presented by SkillsPlus International Inc. - $525 per student. Board Approved</span></a>. </li><li>People also enroll in these California Designated Representative courses for:<br /> <a href="https://cvent.me/2KP04G" target="_blank"><span style="color: #6fa8dc;">3PL (third-party logistics providers)</span></a> | <a href="https://cvent.me/wQzd9m" target="_blank"><span style="color: #6fa8dc;">Reverse Distributors</span></a></li></ul>
<h3>
Designated Representative - Wholesaler License - California State Board of Pharmacy</h3>
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According to the Board, "To be licensed as a Designated Representative in California, you must satisfy the requirements under Business and Professions Code section 4053. Wholesale operations that distribute dangerous drugs or dangerous devices must be supervised by a registered pharmacist or an individual approved by the board as a designated representative. These companies may not operate unless the pharmacist or designated representative is physically on the licensed premises. To ensure proper control at all times, the board recommends that there be more than one person approved to supervise operations."<br />
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<a href="https://www.pharmacy.ca.gov/applicants/desig_rep.shtml" target="_blank"><span style="color: #6fa8dc;">Download the Designated Representative - Wholesaler License Application Form - California State Board of Pharmacy</span></a></div>
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<h3>
California Board of Pharmacy Designated Representative Wholesaler Training Course </h3>
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If you are applying for a California Designated Representative Wholesaler license, then you’re also going to need to include proof of required training in your license application packet.<br />
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The proof of required training is a form called the training affidavit. You can earn a training affidavit by taking a California Designated Representative training course approved by the Board.<br />
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<a href="https://cvent.me/VnkZL8" target="_blank"><span style="color: #6fa8dc;">Learn more and purchase this California Board of Pharmacy Designated Representative Wholesaler Training Course — presented by SkillsPlus International Inc.</span></a><br />
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<ul>
<li>This course is approved by the California Board of Pharmacy.</li>
<li>Designed specifically for drug/device wholesalers</li>
<li>Successful class completion earns a training affidavit accepted by the Board, to include in your Designated Representative license application.</li>
<li>More than 7,000 students have taken our courses</li>
<li>SkillsPlus International Inc. has deep experience, offering a Designated Representative training course continuously (without interruption) since 2002.</li>
<li>Our online courses run on popular devices and operating systems.</li></ul><br /><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiwzQ8uUZ93FW2eEDz80qXiix-xrsJP_l4Ixat0ccIeNztBw5dYOLhIQH6eqUf4_n3c_ZjwHeP-vLY9zBj4x3EueoSONGFYDTsBMT_Rt2l42YFAnhQIEtjjTkK8fCxG12M9Dkf9-JAR5TE/s960/2021+01Jan+GG+DR+Wlse.png" style="margin-left: auto; margin-right: auto;"><img alt="Learn more and buy California Board of Pharmacy Designated Representative Wholesaler Training Course - presented by SkillsPlus International Inc. - $525 per student. Board Approved. Image of the Golden Gate Bridge." border="0" data-original-height="720" data-original-width="960" height="300" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiwzQ8uUZ93FW2eEDz80qXiix-xrsJP_l4Ixat0ccIeNztBw5dYOLhIQH6eqUf4_n3c_ZjwHeP-vLY9zBj4x3EueoSONGFYDTsBMT_Rt2l42YFAnhQIEtjjTkK8fCxG12M9Dkf9-JAR5TE/w400-h300/2021+01Jan+GG+DR+Wlse.png" title="Learn more and buy California Board of Pharmacy Designated Representative Wholesaler Training Course - presented by SkillsPlus International Inc. - $525 per student. Board Approved." width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><a href="https://cvent.me/VnkZL8" target="_blank"><span style="color: #6fa8dc;">Learn more and buy California Board of Pharmacy Designated Representative Wholesaler Training Course - presented by SkillsPlus International Inc. - $525 per student. Board Approved. </span></a></td></tr></tbody></table><br /><div class="separator" style="clear: both; text-align: center;"><br /></div><div class="separator" style="clear: both; text-align: left;">Keywords and Phrases<br />California Board of Pharmacy; California State Board of Pharmacy; designated representative; approved; accepted; recognized; certified; training; affidavit; certificate; certification; program; course; class; webinar; seminar; workshop; event; license; application; form; online; web; eLearning; provider; vendor; seller; taught by; presented by; buy; purchase; enroll; register; wholesaler</div><div class="blogger-post-footer">Call us, SkillsPlus International Inc., at (415) 948-5220 ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
</div>Austin Leehttp://www.blogger.com/profile/02068495179758051574noreply@blogger.com2tag:blogger.com,1999:blog-7627527756229223913.post-39046375947302121112021-05-20T09:53:00.000-07:002021-05-20T09:53:01.625-07:00California Exemptee License Training - Closed Captioning<p></p><ul style="text-align: left;"><li><a href="https://cvent.me/OmKRnG" target="_blank"><span style="color: #6fa8dc;">Purchase now to take this online class, California HMDR Exemptee license training certification course</span></a></li></ul><h3 style="text-align: left;">Closed Captioning Added To Our Exemptee Training Course</h3><p></p><blockquote style="border: none; margin: 0 0 0 40px; padding: 0px;"><p style="text-align: left;">We've added something new, closed captioning. Students can read what the course instructor is teaching. This feature helps ESL (English as a second language) students, and hard of hearing students. </p></blockquote><h3 style="text-align: left;">About Our California Exemptee License Training Certification Course</h3><p></p><ul style="text-align: left;"><li>$525 per student. No extra fees to retake any of the quizzes.</li><li>Recognized by the CDPH. By the way, the Exemptee license application asks, "Have you completed training program(s) that address the following: (Attach copy of completed training certificate) …"</li><li>This course covers all topics specified in the license application.</li><li>The online classroom is open 24 x 7 for your convenience. Come and go as needed.</li></ul><p></p><p>California home medical device retail laws require that companies carrying items needing a prescription have Exemptees (or pharmacists) responsible for the distribution of these items. For regulatory compliance, a company's Exemptee(s) must complete training recognized by the California Department of Public Health (CDPH), Food and Drug Branch.</p><p>This Exemptee course is offered by SkillsPlus International Inc. and is approved and accepted by the CDPH. Successful course completion earns a course completion certificate that you will include in your Exemptee license application. </p><p>Give us a call if you have any questions: (415) 948-5220</p><p style="text-align: center;">- - -</p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj8p10B3gjx3kta1MXjQw8GWOLGivyNgiC5oFtUjqaq3NnYEvkB3nBmR-F8eaJND52sVv_VD1hN1n8yetzsiuk_jwe-obHsRxtUJIhXQqMC1kR_1ZwTgcVln1LS9IFgz1SEF8zOFCdLtPY/s960/2019+08Aug+HMDR.png" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img alt="Purchase now to take this online class, California HMDR Exemptee license training certification course" border="0" data-original-height="960" data-original-width="720" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj8p10B3gjx3kta1MXjQw8GWOLGivyNgiC5oFtUjqaq3NnYEvkB3nBmR-F8eaJND52sVv_VD1hN1n8yetzsiuk_jwe-obHsRxtUJIhXQqMC1kR_1ZwTgcVln1LS9IFgz1SEF8zOFCdLtPY/w300-h400/2019+08Aug+HMDR.png" title="Purchase now to take this online class, California HMDR Exemptee license training certification course" width="300" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><a href="https://cvent.me/OmKRnG" style="text-align: left;" target="_blank"><span style="color: #6fa8dc;">Purchase now to take this online class, California HMDR Exemptee license training certification course</span></a></td></tr></tbody></table><br /><p style="text-align: center;"><br /></p><div class="blogger-post-footer">Call us, SkillsPlus International Inc., at (415) 948-5220 ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
</div>Austin Leehttp://www.blogger.com/profile/02068495179758051574noreply@blogger.com3tag:blogger.com,1999:blog-7627527756229223913.post-54232170219295483792021-05-07T12:38:00.002-07:002021-07-29T07:56:15.848-07:00U.S. FDA Outlines Inspection and Assessment Activities - Precision Vaccinations .com<p></p><ul style="text-align: left;"><li><a href="http://www.skillsplusinc.com/CBPresent.htm" target="_blank"><span style="color: #6fa8dc;">People also ask about FDA CGMP Online Training - recommended FDA GMP online training courses provided by SkillsPlus International Inc</span></a>.</li></ul><p></p><p>According to the article:</p><p>"The U.S. Food and Drug Administration issued a new report titled “Resiliency Roadmap for FDA Inspectional Oversight,” outlining the agency’s inspectional activities during the COVID-19 pandemic.</p><p>Its detailed plan to move toward a more consistent state of operations, including the FDA’s priorities related to this work going forward."</p><p>Read the full source article: <a href="https://www.precisionvaccinations.com/2021/05/07/us-fda-outlines-inspection-and-assessment-activities" target="_blank"><span style="color: #6fa8dc;">U.S. FDA Outlines Inspection and Assessment Activities - Precision Vaccinations.com</span></a></p><p>Read the report here: <a href="https://www.fda.gov/media/148197/download" target="_blank"><span style="color: #6fa8dc;">Resiliency Roadmap for FDA Inspectional Oversight - FDA.gov</span></a></p>
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</div>Austin Leehttp://www.blogger.com/profile/02068495179758051574noreply@blogger.com0tag:blogger.com,1999:blog-7627527756229223913.post-91176753048318218182021-04-20T09:38:00.003-07:002021-07-29T07:56:39.373-07:00FDA overdue on guidance as DSCSA deadline looms - RAPS.org<p></p><ul style="text-align: left;"><li><a href="http://www.skillsplusinc.com/CBPresent.htm" target="_blank"><span style="color: #6fa8dc;">People also recommend this: FDA CGMP Online Training - trusted FDA GMP online training courses offered by SkillsPlus International Inc</span></a>. </li><li>State-approved <a href="https://desreptraining.blogspot.com/p/california.html" target="_blank"><span style="color: #6fa8dc;">California Designated Representative training courses</span></a> for: <a href="https://cvent.me/VnkZL8" target="_blank"><span style="color: #6fa8dc;">wholesalers</span></a> | <a href="https://cvent.me/2KP04G" target="_blank"><span style="color: #6fa8dc;">3PL</span></a><br /></li></ul><p></p><p>According to the article:</p><p></p><blockquote><p>"Legal experts advised the pharmaceutical industry to start preparing now to meet the November 2023 deadline for having fully electronic interoperable systems in place for tracking products through the supply chain under the Drug Supply Chain Security Act (DSCSA).</p><p>Food and drug law attorneys outlined ways the industry can meet these requirements at a 15 April traceability forum on DSCSA implementation sponsored by the Healthcare Distributors Association (HDA)."</p></blockquote><p></p><p>Read the full source article: <a href="https://www.raps.org/news-and-articles/news-articles/2021/4/fda-overdue-on-guidance-as-dscsa-deadline-looms" target="_blank"><span style="color: #6fa8dc;">FDA overdue on guidance as DSCSA deadline looms - RAPS.org</span></a></p><p>You might also be interested in: <a href="https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/drug-supply-chain-security-act-law-and-policies" target="_blank"><span style="color: #6fa8dc;">Drug Supply Chain Security Act Law and Policies - FDA.gov</span></a></p>
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</div>Austin Leehttp://www.blogger.com/profile/02068495179758051574noreply@blogger.com0tag:blogger.com,1999:blog-7627527756229223913.post-50291390404330737732021-04-15T08:21:00.001-07:002021-07-29T08:37:29.819-07:00Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency | Guidance for Industry - FDA.gov<p></p><ul style="text-align: left;"><li><a href="http://www.skillsplusinc.com/CBPresent.htm" target="_blank"><span style="color: #6fa8dc;">People also search for FDA CGMP Online Training - respected FDA GMP online training courses provided by SkillsPlus International Inc. </span></a></li></ul><p></p><p>According to the guidance document:</p><p></p><blockquote><p>"FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic.</p><p>FDA is issuing this guidance to describe how we will request and conduct voluntary remote interactive evaluations at facilities where drugs are manufactured, processed, packed, or held; facilities covered under FDA's bioresearch monitoring (BIMO) program; and outsourcing facilities registered under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for the duration of the COVID-19 public health emergency.</p><p>This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Secretary of Health and Human Services (HHS) on January 31, 2020, effective January 27, 2020, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d(a)(2))."</p></blockquote><p></p><p>View the full source document: <a href="https://www.fda.gov/media/147582/download" target="_blank"><span style="color: #6fa8dc;">Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency Guidance for Industry - FDA.gov (PDF)</span></a></p>
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</div>Austin Leehttp://www.blogger.com/profile/02068495179758051574noreply@blogger.com0tag:blogger.com,1999:blog-7627527756229223913.post-49029626820809026662021-04-01T13:54:00.003-07:002022-03-23T06:16:15.830-07:00California Designated Representative 3PL Course<blockquote><span style="font-size: medium;">SkillsPlus International Inc. is the <u>ONLY</u> Board-approved provider of all three of the following online training programs.</span></blockquote><p></p><ul><li><span style="color: #6fa8dc; font-size: medium;"><a href="https://cvent.me/2KP04G" target="_blank"><span style="color: #6fa8dc;">Buy Now! California Designated Representative 3PL Training</span></a></span></li><li>Some also buy Calif Des Rep courses for: <a href="https://cvent.me/VnkZL8" target="_blank"><span style="color: #6fa8dc;">Wholesalers</span></a> | <a href="https://cvent.me/wQzd9m" target="_blank"><span style="color: #6fa8dc;">Reverse Distributors</span></a></li></ul><h2 style="text-align: left;">California Designated Representative-3PL Training Course</h2><p></p><p>If you are applying for a California Designated Representative 3PL license, then you’re also going to need to include proof of required training (specifically, a training affidavit) in your California Designated Representative-3PL license application packet. Earn a training affidavit by taking any of our California Designated Representative training courses.</p><h3 style="text-align: left;">About this online training course:</h3><p></p><ul style="text-align: left;"><li>Price: $525 per student</li><li>Enter our online classroom to take the course. Available 24 x 7.</li><li>This course is approved by the California State Board of Pharmacy.</li><li>The course covers all required topics specified in the Board's license application.</li><li>Successful course completion earns a training affidavit accepted by the Board, to include in your California Designated Representative 3PL license application.</li><li><a href="https://cvent.me/2KP04G" target="_blank"><span style="color: #6fa8dc;">Sign-Up Now! California Designated Representative 3PL online training course</span></a></li></ul><p></p><p> </p><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto;"><tbody><tr><td style="text-align: center;"><span style="margin-left: auto; margin-right: auto;"><a href="https://cvent.me/2KP04G" target="_blank"><img alt="California Designated Representative-3PL Training Course. Image of a glowing blue laptop against a dark background." border="0" data-original-height="528" data-original-width="1056" height="200" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEii8yD0seeGrTVT_Hzn0I9zOzb83XT4GJYMgXVpQ5KITFeG7CcJNF4fXWbAjCZpM2za7jEnGsJ-3V-HD5GqNPRoIPlBZpscWoHPF1g1qNlk4XENGToM95nPL-dl-ajwtvFCZwy0CW9r_nU/w400-h200/2021+04Apr+DR+3PL.png" title="California Designated Representative-3PL Training Course. Board-Approved." width="400" /></a></span></td></tr><tr><td class="tr-caption" style="text-align: center;"><a href="https://cvent.me/2KP04G" target="_blank"><span style="color: #6fa8dc;">Register for this class, California Designated Representative-3PL Training Course. <br />Earns a training affidavit accepted by the California Board of Pharmacy.</span></a></td></tr></tbody></table><br /><p></p><div class="blogger-post-footer">Call us, SkillsPlus International Inc., at (415) 948-5220 ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
</div>Austin Leehttp://www.blogger.com/profile/02068495179758051574noreply@blogger.com9tag:blogger.com,1999:blog-7627527756229223913.post-33858018243125229652021-03-02T07:58:00.001-08:002021-07-29T08:37:58.454-07:00Drug industry pushes FDA to solve growing inspection backlog - Politico<p> <span style="font-size: x-small;">AD </span>- <span style="font-size: medium;"><a href="http://www.skillsplusinc.com/" target="_blank"><strong><span style="color: #6fa8dc;">FDA GMP Online Training Courses by SkillsPlus Intl Inc</span></strong></a><span style="color: #6fa8dc;">.</span></span><span style="color: #6fa8dc;"> </span>- <span style="font-size: x-small;">AD</span></p><p>I had to read this snippet very carefully, and re-read it several times to make sure I completely understood the statistics reported. I suggest you do the same.</p><p>According to the article:</p><p>"From March through September, FDA inspected just three plants outside the U.S., well below the 600-plus it visited in each of the prior two years, the Government Accountability Office said last month. FDA has also struggled to keep up with inspections within U.S. borders, conducting just 52 during the same seven-month period last year, compared with roughly 400 each in 2019 and 2018."</p><p>Read the full source article: <a href="https://www.politico.com/news/2021/03/02/fda-pandemic-drug-inspection-471979" target="_blank"><span style="color: #6fa8dc;">Drug industry pushes FDA to solve growing inspection backlog - Politico</span></a></p>
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</div>Austin Leehttp://www.blogger.com/profile/02068495179758051574noreply@blogger.com0tag:blogger.com,1999:blog-7627527756229223913.post-11833123354600905972021-02-03T07:09:00.001-08:002021-07-29T08:38:20.149-07:00 FDA names its first medical device cybersecurity director - Fierce Biotech<p></p><ul style="text-align: left;"><li><a href="https://skillsplusintl.blogspot.com/p/popular-online-gmp-training.html" target="_blank"><span style="color: #6fa8dc;">FDA GMP QSR cGMP Online Training - recommended GMP online training courses offered by SkillsPlus International Inc.</span></a> </li></ul><p></p><p>According to the article:</p><p>"The FDA has appointed its first medical device cybersecurity chief to help guide the agency’s regulatory strategies as more devices become interconnected—and potentially more vulnerable to digital attacks and breaches.</p><p>Kevin Fu, an associate professor and research fellow at the University of Michigan, was named to the post. He will serve a one-year term as an expert-in-residence at the agency’s Center for Devices and Radiological Health (CDRH) as well as at its nascent Digital Health Center of Excellence, which launched last fall."</p><p>Read the full source article: <a href="https://www.fiercebiotech.com/medtech/fda-names-its-first-medical-device-cybersecurity-director" target="_blank"><span style="color: #6fa8dc;">FDA names its first medical device cybersecurity director - Fierce Biotech</span></a></p><p><a href="http://www.skillsplusinfo.blogspot.com/" target="_blank"><span style="color: #6fa8dc;">Return to SkillsPlus International Info Blog - Home</span></a></p>
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</div>Austin Leehttp://www.blogger.com/profile/02068495179758051574noreply@blogger.com0tag:blogger.com,1999:blog-7627527756229223913.post-41694232074544855102021-01-28T09:24:00.003-08:002021-05-12T10:45:58.453-07:00Exemptee License Training - California Exemptee Certification<p></p><ul style="text-align: left;"><li><a href="https://cvent.me/OmKRnG" target="_blank"><span style="color: #6fa8dc;">Buy now! California Exemptee License Training Course</span></a></li><li><a href="http://www.exemptee.org/exempteeclass.htm" target="_blank"><span style="color: #6fa8dc;">California HMDR Exemptee License Training. California Exemptee training certification course for home medical device retail license applicants and their managers. Recognized by the California Department of Public Health - Food and Drug Branch.</span></a> </li></ul><p></p><h2 style="text-align: left;">Exemptee License Training - California Exemptee Certification</h2><p><a href="http://www.skillsplusinc.com/hmdr.htm" target="_blank"><span style="color: #6fa8dc;">An online training program for home medical device retailer Exemptee license applicants and their supervisors - California Exemptee License Training Certification Course - learn more & buy</span></a></p><p>California home medical device retail law requires companies carrying items needing a prescription to have an Exemptee (or pharmacist) responsible for the distribution of these items. In order to be in regulatory compliance, the company's Exemptee(s) must complete required training approved and accepted by the California Department of Public Health (CDPH) - Food and Drug Branch.</p><p>Such an Exemptee course is offered by SkillsPlus International Inc. and is recognized by the CDPH. Successful course completion earns a course completion certificate suitable for your Exemptee license application submission.</p><h2 style="text-align: left;">Details About Our California HMDR Exemptee Training Course</h2><p></p><ul style="text-align: left;"><li><a href="https://cvent.me/OmKRnG" target="_blank"><span style="color: #6fa8dc;">Learn more and buy now | California Exemptee Training</span></a></li><li>$525 per student - no extra fees to retake any of the quizzes</li><li>Recognized by the CDPH. By the way, the Exemptee license application asks, "Have you completed training program(s) that address the following: (Attach copy of completed training certificate) …"</li><li>This course covers all topics specified in the license application.</li><li>The online classroom is open 24 x 7 for your convenience. Come and go as needed.</li><li>We've added something new, closed captioning. Students can read what the course instructor is teaching. This feature helps ESL (English as a second language) students, and hard of hearing students. </li><li>Highly recommended, offered continuously since 2002.</li></ul>
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</div>Austin Leehttp://www.blogger.com/profile/02068495179758051574noreply@blogger.com1tag:blogger.com,1999:blog-7627527756229223913.post-43703835968687641582021-01-19T11:34:00.001-08:002021-01-19T12:08:25.276-08:00Top pharma industry predictions for 2021 - Pharma Manufacturing<p></p><ul style="text-align: left;"><li><a href="http://www.skillsplusinc.com/serv01.htm#Our%20Most%20Popular%20Courses" target="_blank"><span style="color: #6fa8dc;">FDA GMP QSR cGMP Online Training - GMP online training courses offered by SkillsPlus International Inc.</span></a></li></ul><p></p><p>According to the article:</p><p>"Perhaps more than most other industries, the landscape of pharma was radically altered by the pandemic. Now, with an end to the coronavirus within reach, experts say that the industry will soon be taking stock of how it navigated the pandemic and what the sudden shifts in operations and regulations could mean in the long-term. </p><p>Here’s a look at some of the top trends experts say will impact the industry in 2021 and predictions about how the pandemic could permanently change life in pharma."</p><p>The predictions are categorized by:</p><ul style="text-align: left;"><li>Therapeutic innovations</li><li>Manufacturing capacity</li><li>Supply chain</li><li>Manufacturing technologies</li><li>Drug development</li><li>Regulatory changes, and</li><li>Market trends</li></ul><ul style="text-align: left;"></ul><ul style="text-align: left;"></ul><ul style="text-align: left;"></ul><ul style="text-align: left;"></ul><ul style="text-align: left;"></ul><p>Read the full source article: <a href="https://www.pharmamanufacturing.com/articles/2021/top-pharma-industry-predictions-for-2021/" target="_blank"><span style="color: #6fa8dc;">Top pharma industry predictions for 2021 - Pharma Manufacturing</span></a></p><br /><br />
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</div>Austin Leehttp://www.blogger.com/profile/02068495179758051574noreply@blogger.com0tag:blogger.com,1999:blog-7627527756229223913.post-83109154113737160642021-01-14T10:52:00.003-08:002021-07-29T08:39:13.230-07:00FDA Veteran Woodcock Being Considered to Lead Agency Under Biden - Bloomberg News<p></p><ul style="text-align: left;"><li>FDA GMP QSR cGMP Online Training: <a href="http://www.gmpprof.com/index.html" target="_blank"><span style="color: #6fa8dc;">FDA cGMP QSR GMP Online Training - popular online training courses</span></a> by SkillsPlus International Inc. #FDA #cGMP #GMP #QSR #training </li></ul><p></p><p>According to the article:</p><p>"Janet Woodcock, a 30-year veteran of the Food and Drug Administration, is being considered by President-elect Joe Biden to serve as commissioner of the agency, according to people familiar with the selection process.</p><p>Woodcock is expected to serve as acting head of the drug regulator after Biden’s inauguration next week, while being vetted by the Biden team for the permanent job along with former FDA principal deputy commissioner Joshua Sharfstein, according to the people."</p><p>Read the full news article: <a href="https://www.bloomberg.com/news/articles/2021-01-14/fda-veteran-woodcock-being-considered-to-lead-agency-under-biden" target="_blank"><span style="color: #6fa8dc;">FDA Veteran Woodcock Being Considered to Lead Agency Under Biden - Bloomberg News</span></a></p>
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