FDA - Hurricane Preparedness Free Tips

Be safe, be prepared. Follow the link below to the FDA's tips on hurricane preparedness.

Public Health Focus > Hurricane Safety Checklist:

"The FDA reminds consumers to take precautions for storing water and ensuring the safety of their food and medical supplies for themselves, their families, and their pets during and after any hurricane-related rain, possible flooding and power outages.

The agency also reminds consumers that it is important to have a plan in place for emergency medication and medical supplies for both people and animals. This is especially true for those with health concerns, particularly if the power goes out.

In general, FDA encourages consumers to: . . . "

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FDA : Draft Guidance - Contract Manufacturing Arrangements for Drugs: Quality Agreements; Availability

Comments are due to FDA by July 29, 2013.

Federal Register | Draft Guidance for Industry on Contract Manufacturing Arrangements for Drugs: Quality Agreements; Availability:

"This guidance describes our current thinking on defining, establishing, and documenting the responsibilities of each party (or all parties) involved in the contract manufacturing of drugs subject to Current Good Manufacturing Practice (CGMP). In particular, we describe how parties involved in the contract manufacturing of drugs can utilize Quality Agreements to delineate their responsibilities and assure drug quality, safety, and efficacy."

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Food or Dietary Supplement - Therapeutic Claims = Drugs

FDA Law Blog: Using Scientific Literature in Food or Dietary Supplement Marketing? Proceed with Caution:

"Recent actions by FDA and the FTC serve as reminders that both agencies will consider the use of scientific literature in determining whether marketing for a food or dietary supplement conveys disease treatment or prevention.

FDA recently issued a warning letter to a company that sells eye health dietary supplements. FDA alleged that the company’s website included “therapeutic claims” that established that its products were unapproved new drugs."

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Choose Live On-Site Instructor-Led GMP Training - - Benefits

On-site training, taught live by an instructor, is the perfect choice for companies that need to train groups of employees.

The Benefits of Live On-Site Instructor-Led cGMP Training:

You'll . . .

1. Get a maximum number of employees trained in new skills in a minimal amount of time on the date, and location of your choice. 
2. Be able to deliver the same customized message & course content at the same time, ensuring everybody gets on the same page. 
3. Ensure knowledge & skills transfer from classroom to workplace.
4. Get an expert trainer's insights and hear real-world examples.
5. Experience face-to-face interaction with real-time feedback.
6. Get a more comfortable training environment that supports the learning of complex material.

Taking advantage of onsite instructor-led training classes gives you the optimal balance of facilitation, group exercises, case studies, and practical application exercises. Call our master trainer, Allan Dewes, to arrange your next client site class, (954) 873-7422.

Explore the full line of SkillsPlus Intl Inc. live on-site courses:
On-Site cGMP, QSR, and Other Compliance Training Courses by SkillsPlus International Inc.

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Root Cause Analysis for Better Deviation Investigations - Onsite Courses - Popular

These highly popular cGMP & QSR training classes are taught at the location of your choice, as a client on-site in-house training. You might be interested in two of our highly inter-related courses.

1. Root Cause Analysis for Better Investigations, and
2. Deviation Investigation Reports

- - - FIRST - - -

Root Cause Analysis for Better Deviation Investigations: On-site Training by SkillsPlus International Inc.:

"Purpose:

• To conduct or facilitate an individual or team-based investigation that solves problems and gets results, and complies with FDA expectations in the pharmaceutical and biotech industries. 

Objectives
1. Use tools and techniques to effectively identify the deviation statement.
2. Identify the root cause of the deviation.
3. Generate and objectively select the best corrective and preventive actions.
4. Assess the risk of implementing the corrective action and preventive action.
5. Develop a contingency plan to preventive action implementation.
6. Create corrective actions and preventive action metrics. 

About the Class
1. This class uses current deviations to practice the techniques taught.
2. The optional final exam is approximately 25 questions.
3. Each student receives a student guide containing a representation of the program's
slides and graphics with space provided for note taking.
4. This class can accommodate up to 25 people.
5. Duration: 8 hours."

'via Blog this'

- - - SECOND - - -

Deviation Investigation Reports: On-Site Training by SkillsPlus International Inc.:

Purpose:

• To use the data collected in an investigation to write a report and answer management and FDA questions.

 Objectives 

1. Increase investigation report suitability for FDA review. 
2. Decrease the number of reports returned by internal reviewers. 
3. Write supported deviation statements. 
4. Provide a detailed background statement to include related information, investigations, affected materials and references. 
5. Document deviation investigation findings. 
6. State the root cause with supporting facts. 
7. Generate supported, plausible, and defensible corrective actions. 
8. Develop effectiveness measures for the corrective actions. 
9. Generate realistic preventive actions. 
10. Develop effectiveness measures for the preventive actions. 
11. Develop a follow up plan for corrective and preventive actions. 
12. Write accurate executive summary statements. 

 About the Class

1. In-house deviation reports will be used to demonstrate and practice the skills and principles of this class.
2. This course is best taught in a computer lab. We can ship computer labs to your site if needed.
3. This course is customized to reflect your company procedure on writing deviation investigation reports. As we review that document we will make any recommendations to for change that we feel would be helpful.
4. The optional final exam is approximately 25 questions.
5. Each student receives a student guide containing a representation of the program's  slides and graphics with space provided for note taking.
6. This class can accommodate up to 12 people.
7. Duration: 8 hours as a minimum.

For more information:

• Root Cause Analysis for Better Deviation Investigations: On-site Training by SkillsPlus International Inc.
• Deviation Investigation Reports: On-Site Training by SkillsPlus International Inc.

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Last Chance For A Discount - GMP-QSR Trainer Certification - May 6-10 Public Seminar

This year is flying by so fast!

Do yourself a favor and do two things by April 15th:

1. Get your taxes filed with the IRS, and
2. Sign-up now for our public seminar (the registration discount ends on April 15th)

If you're still on the fence about attending, be drawn to sunny and warm Florida, before school is out for the Summer . . .

Things to do while you're here in the Fort Lauderdale & Miami area for our public seminar:

• Fort Lauderdale Visitors Bureau:  http://www.sunny.org/
• Miami Visitors Bureau:  http://www.miamiandbeaches.com/
• Visit Florida:  http://www.visitflorida.com/

Oh, by the way, did I mention . . . sign-up before April 15th in order to qualify for the early registration discount to our upcoming May 6-10, 2013 Public Seminar in Fort Lauderdale, FL.

• QSR cGMP Trainer Certification Program - Public Seminar Info, Location, Brochure, Registration: http://www.skillsplusinc.com/Pub_Sem.htm

Learn more about SkillsPlus Intl Inc. products & services:  http://www.skillsplusinc.com/

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How To Become A Better GMP Trainer

Trainers must be skilled!

• They must be expert course designers and facilitators
• They must pay attention to the experiential learning process
• They must keep students involved, engaged, and energized

It’s a given that GMP & QSR trainers must have mastery over the regulations that they are teaching. Mastering applicable laws, regulations, directives, standards, guidance, and compendia for manufacturing biologics, drugs, dietary supplements, and medical devices is essential for raising your company’s employees and management team compliance competency.

GMP & QSR trainers must also be able to help others expand their knowledge of relevant regulatory requirements, and to help others apply that knowledge in the workplace.

What does that mean?

It means that trainers must have the skills needed to teach others. We often find that trainers, program designers, training supervisors, training managers, and others who conduct GMP or QSR training in the pharmaceutical, biotech, medical device or dietary supplement industries need help in developing their training skills.

Expert GMP & QSR trainers:

1. Focus on experiential learning processes
2. Teach in a facilitation and learning style that’s appropriate to particular regulatory topics
3. Design and facilitate learning activities
4. Facilitate meaningful discussions, and create safe environments through the debrief process
5. Model different teaching strategies
6. Tell compelling case stories
7. Keep students involved, engaged, and energized

If you think you or a member of your team needs help in developing training skills, then consider attending our only 2013 offering of this course, on May 6-10th:
 GMP-QSR Trainer Certification Public Seminar by SkillsPlus International Inc.

 

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Enhance Your Training Skills - GMP & QSR Trainer Certification Course - Discount Ends Apr 15

Sign-up soon!  Here's why . . .

1. The early registration discount expires April 15th.
2. This is the most popular trainer certification course on the market!

Don't delay, and save!  See you soon in warm and sunny Fort Lauderdale!

Overview:

This is a five-day public seminar that leads participants through many different ways to teach CGMPs and QSRs. Learn what your instructor is thinking about during sessions, so that you can repeat that training approach in your organization. Students make two presentations demonstrating their skills during the class. This class is also suitable for food and dietary supplement manufacturers.

Course Details:

• Learn how to train CGMPs and QSR courses from successful compliance professionals
• Experience, practice, and master the skills to make compliance training fun, informative, and exciting

Participants will learn how to:

• Explain the essentials of the CGMP/QSR regulations.
• Use the philosophical basis for the rules and interpretation to respond to CGMP/QSR related questions.
• Demonstrate techniques to present CGMP/QSR content in memorable ways.
• Design and conduct activities that reinforce learning.
• Facilitate discussions and questions like a pro.
• Respond to difficult questions.
• Deal successfully with difficult students.
• Manage classroom media

Event Details:

Date: May 6-10, 2013

Location:  Fort Lauderdale, FL

Seminar & Lodging Location:  Pelican Grand Beach Resort in Fort Lauderdale

Additional Information:

About this cGMP and QSR Trainer Certification Course - on the SkillsPlus Intl Inc. website

Brochure - QSR-cGMP Trainer Certification Course - A Public Seminar Offered by SkillsPlus Intl Inc.

Register for this cGMP and QSR Trainer Certification Course by SkillsPlus Intl Inc.

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In-Plant On-Site GMP Training & QSR Training Courses

We offer onsite, in-plant GMP training & QSR training courses.

If you've got training needs, we've got the courses and classes for you!

1. Our live classes span QSR and cGMPs, and more! 
2. We're training experts with experience! 
3. Avoid boring courses. Students love our exciting, energizing, and engaging classes! 

Learn more about our training offerings that can be delivered at the location of your choice:
Live, in-plant, on-site, GMP training & QSR training courses taught by SkillsPlus Intl Inc.

You might also be interested in:
SkillsPlus Intl Inc training products and services

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CGMP Trainer Certification - QSR Trainer Certification - May 6-10, 2013 in FL - Very Popular Annual Public Seminar - Don't Miss Out!

Allan Dewes - SkillsPlus Intl Inc.

Pursue your maximum potential as a trainer in the FDA-regulated industries.

Don't miss out on this highly popular annual public seminar.

Overview:

This is a five-day public seminar that leads participants through many different ways to teach CGMPs and QSRs. Learn what your instructor is thinking about during sessions, so that you can repeat that training approach in your organization. Students make two presentations demonstrating their skills during the class. This class is also suitable for food and dietary supplement manufacturers.

Course Details:

Learn how to train CGMPs and QSR courses from successful compliance professionals, headed by Allan Dewes, a well-respected industry master trainer.
Experience, practice, and master the skills to make compliance training fun, informative, and exciting

Event Details:

Date: May 6-10, 2013

Location:  Fort Lauderdale, FL

Seminar & Lodging Location:  Pelican Grand Beach Resort in Fort Lauderdale

Additional Information:

About this cGMP and QSR Trainer Certification Course - on the SkillsPlus Intl Inc. website

Brochure - QSR-cGMP Trainer Certification Course - A Public Seminar Offered by SkillsPlus Intl Inc.

Register for this cGMP and QSR Trainer Certification Course by SkillsPlus Intl Inc.

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GMP QSR Trainer Certification Course - May 6-10, 2013 - Event Rate Hotel Rms - Limited Supply

You need to sign-up for this public seminar quickly!  Here's why . . .

1. There's a limited supply of special rate hotel rooms at the seminar location. The special rate is available through March 25th, or until this block of rooms is sold out.
2. Early registration discount offers will expire soon.
3. This is the most popular trainer certification course on the market!

You can save money in two ways: 1) sign-up soon to qualify for an early registration discount, and 2) book your room at the discounted rate, while they're still available.

Overview:

This is a five-day public seminar that leads participants through many different ways to teach CGMPs and QSRs. Learn what your instructor is thinking about during sessions, so that you can repeat that training approach in your organization. Students make two presentations demonstrating their skills during the class. This class is also suitable for food and dietary supplement manufacturers.

Course Details:

• Learn how to train CGMPs and QSR courses from successful compliance professionals
• Experience, practice, and master the skills to make compliance training fun, informative, and exciting

Participants will learn how to:

• Explain the essentials of the CGMP/QSR regulations.
• Use the philosophical basis for the rules and interpretation to respond to CGMP/QSR related questions.
• Demonstrate techniques to present CGMP/QSR content in memorable ways.
• Design and conduct activities that reinforce learning.
• Facilitate discussions and questions like a pro.
• Respond to difficult questions.
• Deal successfully with difficult students.
• Manage classroom media

Event Details:

Date: May 6-10, 2013

Location:  Fort Lauderdale, FL

Seminar & Lodging Location:  Pelican Grand Beach Resort in Fort Lauderdale

Additional Information:

About this cGMP and QSR Trainer Certification Course - on the SkillsPlus Intl Inc. website

Brochure - QSR-cGMP Trainer Certification Course - A Public Seminar Offered by SkillsPlus Intl Inc.

Register for this cGMP and QSR Trainer Certification Course by SkillsPlus Intl Inc.

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Things To Do in FL - When here for our GMP Trainer Certification Course May 6-10, 2013

Things to do while you're here in the Fort Lauderdale & Miami area for our public seminar:

• Fort Lauderdale Visitors Bureau:  http://www.sunny.org/
• Miami Visitors Bureau:  http://www.miamiandbeaches.com/
• Visit Florida:  http://www.visitflorida.com/

Sign-up soon to get the early registration discount for our upcoming May 6-10, 2013 Public Seminar in Fort Lauderdale, FL.

• QSR cGMP Trainer Certification Program - Public Seminar Info, Location, Brochure, Registration: http://www.skillsplusinc.com/Pub_Sem.htm

Learn more about SkillsPlus Intl Inc. products & services:  http://www.skillsplusinc.com/

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FDA Final Rule on Combo Product CGMPs - New!

Fda (Photo credit: Wikipedia)

Hot off the press!

This final rule clarifies which CGMP requirements apply when drugs, devices, & biological products are combined to create combination products:

Current Good Manufacturing Practice Requirements for Combination Products - A Rule by the Food and Drug Administration on 01/22/2013

In a nutshell:

The FDA is issuing this regulation on the current good manufacturing practice (CGMP) requirements applicable to combination products. This rule is intended to promote the public health by clarifying which CGMP requirements apply when drugs, devices, and biological products are combined to create combination products. In addition, the rule sets forth a transparent and streamlined regulatory framework for firms to use when demonstrating compliance with CGMP requirements for "single-entity" and "co-packaged" combination products.

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• FDA - Proposed Rules To Implement FSMA (skillsplusinfo.blogspot.com)

QSR GMP Trainer Certification in FL - May 6-10, 2013

You've been clamoring for our public seminar at an East Coast location, so here we are!
Visit warm and sunny Fort Lauderdale, FL in May, for this highly recommended public seminar course.

Average Weather In May For Fort Lauderdale, Florida

Register soon to qualify for an early registration discount.

This is the most popular trainer certification course on the market!

• Learn how to train CGMPs and QSR courses from successful compliance professionals
• Experience, practice, and master the skills to make compliance training fun, informative, and exciting

Graduates of this course say that attending this public seminar is a life-changing event!

Overview:

This is a five-day public seminar that leads participants through many different ways to teach CGMPs and QSRs. Learn what your instructor is thinking about during sessions, so that you can repeat that training approach in your organization. Students make two presentations demonstrating their skills during the class. This class is also suitable for food and dietary supplement manufacturers.

Course Details:

Brochure - QSR-cGMP Trainer Certification Course - A Public Seminar Offered by SkillsPlus Intl Inc.

Participants will learn how to:

• Explain the essentials of the CGMP/QSR regulations.
• Use the philosophical basis for the rules and interpretation to respond to CGMP/QSR related questions.
• Demonstrate techniques to present CGMP/QSR content in memorable ways.
• Design and conduct activities that reinforce learning.
• Facilitate discussions and questions like a pro.
• Respond to difficult questions.
• Deal successfully with difficult students.
• Manage classroom media

Event Details:

Date: May 6-10, 2013

Location:  Fort Lauderdale, FL

Seminar & Lodging Location:  Pelican Grand Beach Resort in Fort Lauderdale

Additional Information:

About this cGMP and QSR Trainer Certification Course - on the SkillsPlus Intl Inc. website

Brochure - QSR-cGMP Trainer Certification Course - A Public Seminar Offered by SkillsPlus Intl Inc.

Register for this cGMP and QSR Trainer Certification Course by SkillsPlus Intl Inc.

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GMP Trainer Certification - May 2013 Public Seminar - Register Early To Get A Discount

This is the most popular trainer certification course on the market!

• Learn how to train CGMPs and QSR courses from successful compliance professionals
• Experience, practice, and master the skills to make compliance training fun, informative, and exciting

Graduates of this course say that attending this public seminar is a life-changing event!

Overview:

This is a five-day public seminar that leads participants through many different ways to teach CGMPs and QSRs. Learn what your instructor is thinking about during sessions, so that you can repeat that training approach in your organization. Students make two presentations demonstrating their skills during the class. This class is also suitable for food and dietary supplement manufacturers.

Course Details:

Brochure - QSR-cGMP Trainer Certification Course - A Public Seminar Offered by SkillsPlus Intl Inc.

Participants will learn how to:

• Explain the essentials of the CGMP/QSR regulations.
• Use the philosophical basis for the rules and interpretation to respond to CGMP/QSR related questions.
• Demonstrate techniques to present CGMP/QSR content in memorable ways.
• Design and conduct activities that reinforce learning.
• Facilitate discussions and questions like a pro.
• Respond to difficult questions.
• Deal successfully with difficult students.
• Manage classroom media

Event Details:

Date: May 6-10, 2013

Location:  Fort Lauderdale, FL

Seminar & Lodging Location:  Pelican Grand Beach Resort in Fort Lauderdale

Additional Information:

About this cGMP and QSR Trainer Certification Course - on the SkillsPlus Intl Inc. website

Brochure - QSR-cGMP Trainer Certification Course - A Public Seminar Offered by SkillsPlus Intl Inc.

Register for this cGMP and QSR Trainer Certification Course by SkillsPlus Intl Inc.

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FDA - Proposed Rules To Implement FSMA

Food and Drug Administration logo (Photo credit: Wikipedia)

The FDA has released for public comment a proposed rule on Preventive Controls for Human Food and a proposed rule on Standards for Produce Safety. These rules are two of the proposed rules that are key to the preventive food safety approach established by the 2011 FDA Food Safety Modernization Act (FSMA). The proposed rules build on existing voluntary industry guidelines for food safety, which many producers, growers and others currently follow. FDA expects to soon issue its proposed rule on importer foreign supplier verification; future proposed rules will address preventive controls for animal food, and accreditation of third-party auditors.:

• Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food, and 
• Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption

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The Exemptee Institute just launched

SkillsPlus International Inc. has just launched a new website, The Exemptee Institute, to help California Exemptee applicants and home medical device retailers (HMDR) get the information they need quickly.

Check out our new site:   http://www.exemptee.org/

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• CA HMDR Exemptee Training - The Best Course Around
• Why GMP Training Does Seem To Work
• Regulators, Industry Discuss Potential Impact of IMDRF
• GHTF Archives Can Be Found On The IMDRF Website

Free Tips - GMP Master Training Plan - QSR Master Training Plan

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GMP Posters & QSR Posters - Buy The Entire Collection!

Take advantage of a simple way to reinforce your compliance messages, by putting up posters.

As many trainers and managers know, creating excitement about the next training topic or  keeping the compliance message alive after training is always a challenge.

This product line of large posters, created by the well-known San Francisco artist, Francis Redman, attracts attention and reinforces key compliance messages.

• Buy individual posters, by image or by compliance message
• Buy all the posters on CD

Individual Posters
You can choose individual posters, by selecting an image and then selecting a compliance message.
QSR & GMP Posters by SkillsPlus International Inc.

All The Posters on CD
Better yet, purchase all the posters on CD.  This way you'll get 12 different posters and 56 different slogans to choose from.
QSR & GMP Posters on CD - the Catalog - SkillsPlus Intl Inc.
Purchase QSR & GMP Poster on CD - via the SkillsPlus Intl Inc secure site

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2013 Plan For FDA CDRH Guidance Documents

The CDRH is considering developing a variety of guidance documents in fiscal year 2013. Specific topics and status as final and draft guidance document, are provided in the two lists:

---

Prioritized medical device guidance documents that the Agency intends to publish in FY 2013 ("A-list")

Final Guidance Topics

• Refuse to Accept (RTA) Policy for 510(k) Submissions
• Acceptance and Filing Review for Premarket Approval Applications
• Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies
• In Vitro Companion Diagnostic Devices
• Design Considerations for Pivotal Clinical Investigations for Medical Devices
• De Novo Classification Process (Evaluation of Automatic Class III Designation)
• The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications
• CDRH Appeals Processes
• Medical Device Classification Product Codes
• The Pre-Submission Program and Meetings with FDA Staff
• Mobile Medical Applications
• eCopy
• Premarket Notification [510(k)] Submissions for Medical Devices that Include Antimicrobial Agents

Draft Guidance Topics

• Distinguishing and Reporting Medical Device Recalls from Product Enhancements
• Types of Communication During the Review of Medical Device Submissions
• FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations
• eCopy
• Appropriate Use of Voluntary Consensus Standards in Premarket Submissions

---

Device guidance documents that the Agency intends to publish, as the Agency’s guidance-development resources permit each in FY 2013 ("B-list")

Final Guidance Topics

• Finalizing existing draft guidance documents.

Draft Guidance Topics

• Benefit-Risk Determinations in Premarket Notifications (510(k)s)
• Direct to Consumer (DTC) Genetic Testing: IVDs
• Transfer of Ownership of a Premarket Notification (510(k)) - Questions and Answers
• Custom Devices

Reference:  FDA CDRH Fiscal Year 2013 (FY 2013) Proposed Guidance Development

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2013 GMP Training - It's Time To Start Planning

It's time to start planning your 2013 QSR and cGMP training, and consider engaging SkillsPlus International Inc. as your external trainer.

1. Tackle 2013 now! Coordinating future training is involved, so get ahead of the new year before it arrives. Waiting to start planning conversations in the new year only perpetuates delays, and contributes to pushing off training to the last minute.  
2. Send the right message!  By delaying early planning for 2013 training, there's a risk of sending unintended and unspoken messages that training isn't very important.
3. Deliver the best training!  Brainstorm your training needs with the leaders in GXP compliance training. Sometimes discussing things with, or bringing in external trainers can ratchet up the quality of training that students will experience. SkillsPlus International Inc. is a leader in compliance training, having trained thousands of students, over more than 20 years. Past students rave about the engagement and interactivity experienced in SkillsPlus courses.

Partner now with SkillsPlus International Inc. for your 2013 QSR & GMP training needs, to ensure that your Master Training Plan delivers timely quality training programs throughout the coming year. Simply visit our website to get started:

SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

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