The Best FDA CGMP Training

• Recommended FDA GMP online training courses and programs by SkillsPlus International Inc. 

Respected FDA GMP Online Training Courses & Programs

SkillsPlus International Inc., was incorporated in 1991. We offer training services to pharmaceutical and medical device manufacturers.

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.

Learn more about our basic and advanced GMP online training courses.

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The Best FDA GMP Online Training Courses & Programs

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California Designated Representative Training Course For 3PL (third-party logistics providers)

• Sign-up now! California Designated Representative training course for:
       3PL | Wholesalers | Reverse Distributors 

California Designated Representative Training Course For Third-Party Logistics Providers (3PL)

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.

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.

State-approved by the California State Board of Pharmacy. Nearly 10,000 students have taken one of our state license-related training classes!

This course covers all topics specified on the California Designated Representative 3PL license application form.

California Designated Representative Training Course For 3PL - Learn more >>

California Designated Representative Training Course For 3PL (third-party logistics providers).
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Will Labor Requirements Increase in Meeting DSCSA Milestones? - HealthcarePackaging.com

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According to the article:

"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."

... "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.”"

Read the full source article:  Will Labor Requirements Increase in Meeting DSCSA Milestones? - HealthcarePackaging.com

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Wholesalers | 3PL | Reverse Distributors

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Biden nominates Califf as FDA commissioner - RAPS.org

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According to the article:

"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."

"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.

"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."

Read the full source article:  Biden nominates Califf as FDA commissioner - RAPS.org

The Latest Activities Related To The DSCSA - FDA Website

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Latest Activity - Drug Supply Chain Security Act (DSCSA)

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."

According to the referenced FDA webpage:

"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.

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."

Go to:  Drug Supply Chain Security Act (DSCSA) - FDA.gov

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Former Obama FDA Chief Califf Is Front-Runner to Lead Agency - Bloomberg

• Respected FDA GMP online training courses and programs offered by SkillsPlus Intl Inc. 

According to the article:

"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.

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."

Read the full source article: Former Obama FDA Chief Califf Is Front-Runner to Lead Agency - Bloomberg

Halloween Safety Tips: Costumes, Candy, and Colored Contact Lenses - FDA.gov

• Respected FDA GMP online training programs and courses taught by SkillsPlus International Inc. 

According to the FDA: 

"Enjoy a safe and happy Halloween by following these guidelines.

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.

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.

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:" ...

Source Article:  Halloween Safety Tips: Costumes, Candy, and Colored Contact Lenses - FDA.gov

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California Designated Representative Training Course

• Register now for California Board of Pharmacy Designated Representative Wholesaler Training Course - presented by SkillsPlus International Inc. - $525 per student. Board Approved. 
• People also enroll in these California Designated Representative courses for:
        3PL (third-party logistics providers) | Reverse Distributors

Designated Representative - Wholesaler License - California State Board of Pharmacy

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."

Download the Designated Representative - Wholesaler License Application Form - California State Board of Pharmacy

California Board of Pharmacy Designated Representative Wholesaler Training Course 

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.

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.

Learn more and purchase this California Board of Pharmacy Designated Representative Wholesaler Training Course — presented by SkillsPlus International Inc.

• This course is approved by the California Board of Pharmacy.
• Designed specifically for drug/device wholesalers
• Successful class completion earns a training affidavit accepted by the Board, to include in your Designated Representative license application.
• More than 7,000 students have taken our courses
• SkillsPlus International Inc. has deep experience, offering a Designated Representative training course continuously (without interruption) since 2002.
• Our online courses run on popular devices and operating systems.

Learn more and buy California Board of Pharmacy Designated Representative Wholesaler Training Course - presented by SkillsPlus International Inc. - $525 per student. Board Approved. 

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California Exemptee License Training - Closed Captioning

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Closed Captioning Added To Our Exemptee Training Course

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. 

About Our California Exemptee License Training Certification Course

• $525 per student. No extra fees to retake any of the quizzes.
• 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) …"
• This course covers all topics specified in the license application.
• The online classroom is open 24 x 7 for your convenience. Come and go as needed.

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.

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. 

Give us a call if you have any questions:  (415) 948-5220

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U.S. FDA Outlines Inspection and Assessment Activities - Precision Vaccinations .com

• People also ask about FDA CGMP Online Training - recommended FDA GMP online training courses provided by SkillsPlus International Inc.

According to the article:

"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.

Its detailed plan to move toward a more consistent state of operations, including the FDA’s priorities related to this work going forward."

Read the full source article:  U.S. FDA Outlines Inspection and Assessment Activities - Precision Vaccinations.com

Read the report here:  Resiliency Roadmap for FDA Inspectional Oversight - FDA.gov

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FDA overdue on guidance as DSCSA deadline looms - RAPS.org

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• State-approved California Designated Representative training courses for:  wholesalers | 3PL
  

According to the article:

"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).

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)."

Read the full source article:  FDA overdue on guidance as DSCSA deadline looms - RAPS.org

You might also be interested in:  Drug Supply Chain Security Act Law and Policies - FDA.gov

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Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency | Guidance for Industry - FDA.gov

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According to the guidance document:

"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.

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.

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))."

View the full source document: Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency Guidance for Industry - FDA.gov (PDF)

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SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
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California Designated Representative 3PL Course

SkillsPlus International Inc. is the ONLY Board-approved provider of all three of the following online training programs.

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• Some also buy Calif Des Rep courses for:  Wholesalers | Reverse Distributors

California Designated Representative-3PL Training Course

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.

About this online training course:

• Price: $525 per student
• Enter our online classroom to take the course. Available 24 x 7.
• This course is approved by the California State Board of Pharmacy.
• The course covers all required topics specified in the Board's license application.
• Successful course completion earns a training affidavit accepted by the Board, to include in your California Designated Representative 3PL license application.
• Sign-Up Now! California Designated Representative 3PL online training course

 

Register for this class, California Designated Representative-3PL Training Course.
Earns a training affidavit accepted by the California Board of Pharmacy.

Drug industry pushes FDA to solve growing inspection backlog - Politico

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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.

According to the article:

"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."

Read the full source article: Drug industry pushes FDA to solve growing inspection backlog - Politico

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FDA names its first medical device cybersecurity director - Fierce Biotech

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According to the article:

"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.

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."

Read the full source article:  FDA names its first medical device cybersecurity director - Fierce Biotech

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FDA GMP QSR cGMP Online Training - recommended GMP online training courses offered by SkillsPlus International Inc. 

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Exemptee License Training - California Exemptee Certification

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• 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. 

Exemptee License Training - California Exemptee Certification

An online training program for home medical device retailer Exemptee license applicants and their supervisors - California Exemptee License Training Certification Course - learn more & buy

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.

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.

Details About Our California HMDR Exemptee Training Course

• Learn more and buy now | California Exemptee Training
• $525 per student - no extra fees to retake any of the quizzes
• 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) …"
• This course covers all topics specified in the license application.
• The online classroom is open 24 x 7 for your convenience. Come and go as needed.
• 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. 
• Highly recommended, offered continuously since 2002.

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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. 

Top pharma industry predictions for 2021 - Pharma Manufacturing

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According to the article:

"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. 

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."

The predictions are categorized by:

• Therapeutic innovations
• Manufacturing capacity
• Supply chain
• Manufacturing technologies
• Drug development
• Regulatory changes, and
• Market trends

Read the full source article: Top pharma industry predictions for 2021 - Pharma Manufacturing

FDA GMP QSR cGMP Online Training - GMP online training courses offered by SkillsPlus International Inc.

FDA Veteran Woodcock Being Considered to Lead Agency Under Biden - Bloomberg News

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According to the article:

"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.

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."

Read the full news article:  FDA Veteran Woodcock Being Considered to Lead Agency Under Biden - Bloomberg News

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Free GMP Training Tips
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6 Things We Need From FDA Before Full 2023 DSCSA Enforcement - BioProcess Online

• California Designated Representative Training Courses | 3PL - Wholesaler - Reverse Distributor
• FDA GMP QSR cGMP Training - GMP online training courses

According to the article:

"The journey to industry compliance with the U.S. Drug Supply Chain Security Act (DSCSA) continues to twist and turn with recent requirements going into effect for distributors and dispenser and subsequent delays on enforcement of some of those requirements until Nov. 27, 2023."

"The discussions and perspectives in the meeting were often conflicting and sometimes seemed to ignore insights developed over the past years by several industry workgroups. We would like to suggest some concrete actions the FDA can take now to help bring together a complex and diverse number of sectors in advance of 2023 enforcement:"

Read the full source article:  6 Things We Need From FDA Before Full 2023 DSCSA Enforcement - BioProcess Online

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SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
Free GMP Training Tips
Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
Qualstar Simulation - Advanced GMP Training That's Fun!