FDA Reduces GMP Inspections by 40 Percent, Focuses on Imports - PharmaManufacturing

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

FDA Reduces GMP Inspections by 40 Percent, Focuses on Imports - PharmaManufacturing:

"The FDA plans to conduct 591 domestic good manufacturing practice (GMP) inspections in fiscal 2014 and 2015, down from the 967 performed last year. The agency in turn hopes to perform 30 percent more foreign GMP inspections, conducting 843 inspections each year, up from last year’s 604. Companies will be chosen for inspection based on the agency’s risk-based inspection model that grants leeway to high-quality companies. The FDA takes into account risk factors including Class I recalls and adverse events, as well as compliance history, in applying the risk-based inspections model to its decision making."

'via Blog this'


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GMP Trainers - Why You Should Get Training

GMP Training Certification Course: GMP Trainer Awareness, Certification, and Master Trainer Course - Online Self-Study

• It's important to learn the most effective ways to train your employees
• Never stop learning! Train & be trained as often as possible
• Your training toolbox should have a ton of things in it. 

FDA GMP Trainer Certification Course

"The mediocre teacher tells. The good teacher explains. The superior teacher demonstrates. The great teacher inspires." - William Arthur Ward

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Become A Better GMP Trainer

Updated October 26, 2022

You might also be interested in this course offering.

GMP Trainer Awareness, Certification, and Master Trainer Courses

This online self-study course leads participants through many different ways to teach cGMPs and QSRs. Learn what a class instructor thinks while delivering a training session to students, so you can repeat that training approach in your own organization. 

Pricing | Questions? - Call us:  (415) 948-5220

How This Course Is Implemented

This course is implemented in three phases: Awareness, Certification, and Master Trainer. This is NOT a public seminar workshop. Our public seminar was so popular; we turned it into an online self-study course that fits into your busy schedule.

• GMP Trainer Awareness – Students view presentations covering the course objectives below.
• GMP Trainer Certification – Students view the “Awareness” presentations. Students then prepare elements of a training session demonstrating the application of the content taught in the awareness course, or in some cases, capture and submit video segments of an actual or practice training session. All information submitted will be reviewed and critiqued by a team of Master Trainers. This course is taken simultaneously with the Awareness course.
• GMP Master Trainer – Learn GMP content to assure you know the basic GMP rules. This phase of the program is under development.

In this course, you will learn how to:

• Apply a Participant Centered Approach to training
• Write course objectives
• Development a course assessment
• Describe the difference between ice breakers and activities
• Describe and develop ice breakers for a class
• Describe and develop activities for a class
• Explain the role of the instructor during activities
• Develop an activity debriefing strategy
• Describe various strategies for forming groups
• Design a course presentation
• Identify and demonstrate effective presentation skills
• Develop stories for a class and how to deliver the story
• Develop discussion questions
• Develop and implement discussion follow-up strategies
• Demonstrate the management of disruptive behavior
• Identify the elements of a course assessment validation plan
• Identify the elements of a course evaluation form
• Develop a course evaluation form

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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

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Executive Session - An Advanced GMP Training Course

• FDA cGMP QSR GMP Training - online training courses taught by SkillsPlus International Inc.

Updated July 30, 2024

Sadly, "Executive Session" is no longer available.

- - -

EXECUTIVE SESSION - a cGMP training course
- #FDA #GMP #cGMP #QSR #advanced #training #course

Executive Session is an advanced course that addresses CGMP & QSR issues directly relevant to the executive leadership and executive teams of manufacturers.

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

Related articles

• Do You Have SOP Compliance Problems? (drughealth.blogspot.com)
• 2014 GMP Training Ideas - Executive Session (2014 cGMP Updates) (drughealth.blogspot.com)
• GMP Training - Olympic-Style (drughealth.blogspot.com)

Analytical Procedures and Methods Validation for Drugs and Biologics - New FDA Draft Guidance

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

Updated December 19, 2025

You might be interested in:

Analytical Procedures and Methods Validation for Drugs and Biologics - Guidance for Industry - FDA.gov

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FDA Guidance for Industry Analytical Procedures and Methods Validation for Drugs and Biologics - DRAFT GUIDANCE (February 2014 - PDF):

"This revised draft guidance supersedes the 2000 draft guidance for industry on Analytical Procedures and Methods Validation and, when finalized, will also replace the 1987 FDA guidance for industry on Submitting Samples and Analytical Data for Methods Validation. It provides recommendations on how you, the applicant, can submit analytical procedures and methods validation data to support the documentation of the identity, strength, quality, purity, and potency of drug substances and drug products. It will help you assemble information and present data to support your analytical methodologies."

Source:

• Guidance for Industry: Analytical Procedures and Methods Validation for Drugs and Biologics (PDF - 359KB)

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

Root Cause Investigations Workshop - GMP Training

ROOT CAUSE INVESTIGATIONS WORKSHOP
#FDA #GMP #QSR #cGMP #training #course #class

Learn how to dig deeper and discover what's really below the surface. In this course, students apply root cause analysis tools to real in-plant deviations.

Learn more: http://www.skillsplusinc.com/root_cause.htm

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

Certified Designated Representative

Florida Certified Designated Representative (CDR)

 CERTIFIED DESIGNATED REPRESENTATIVE
"All prescription drug wholesale distributor and out-of-state prescription drug wholesale distributor permittees and applicants must designate in writing at least one natural person to serve as the designated representative for a given establishment.  Such person must have an active certification from the department (a “certified designated representative” or “CDR”)." [Source: Florida Certified Designated Representative: - 'via Blog this']

Go to:  The Designated Representative and Exemptee Blog

FL Certified Designated Representative online e-Learning exam preparation by SkillsPlus Intl Inc.
CA Designated Representative online web-based training certification by SkillsPlus Intl Inc - Available around-the-clock 24 x 7 
The Designated Representative Institute

CA HMDR Exemptee online internet-based training certification by SkillsPlus Intl Inc 
The Exemptee Institute

SkillsPlus Intl Info Blog

FDA Orange Book 2014 - 34th Edition

The 2014 FDA Orange Book (34th Edition) is hot off the press.

This 34th edition of the FDA Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations) is current through December 31, 2013.

View the Orange Book:
FDA Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations) - PDF

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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!

 

Tired Of Boring Training? Then Feel The Thrill of the GMP Olympics!

Updated February 27, 2026:

The GMP Olympics course is no longer available.

You might also like the best and recommended choice for FDA GMP QSR cGMP Online Training: FDA cGMP QSR GMP Online Training - popular online training courses by SkillsPlus International Inc. 

#FDA #cGMP #GMP #QSR #training | Recommended | Respected | Popular | The best choice for FDA CGMP online training courses and programs.

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Upd

• Do your employees avoid CGMP training, claiming they've heard it all? 
• Do they resist attending CGMP training because "their" job is never discussed? 
• Do some employees "drift off" in CGMP training because it is too theoretical? 

If you answered "Yes" to any of these questions, then you need to take a look at our GMP Olympics Refresher course.

Featured Course: GMP Olympics 
Participate in the Olympics! This course challenges even the most seasoned employee's knowledge of CGMPs. This course is definitely not for employees who are new to the industry.

Activities from this highly interactive workshop include:

• Heard on the Street 
• Team-based regulation review 
• GMP Challenge 
• Inspection Detection, and more! 

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

Do You Have SOP Compliance Problems? Need Help?

Updated 12/26/2022

The original post got outdated.

You might also be interested in:

FDA cGMP online training courses by SkillsPlus International Inc.

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• Do CGMP documents contain many errors, or
• Are change controls often side-stepped, or 
• Is the Quality Unit often side-stepped, or 
• Are procedures not always followed?

If you answered "Yes" to any of these questions, then take a look at our Qualstar: A CGMP Training Simulation course.

Featured Course:   Qualstar - A CGMP Simulation
Designed to teach and to change the culture of companies in order to focus on quality and compliance. This competitive simulation is an eye-opener for participant and executive staff observers alike. Issues addressed in this exciting simulation:

1. Documentation problems
2. Procedures not being followed
3. Change control not practiced
4. QA not consulted on deviations 

If this describes some of your issues, then you need to experience Qualstar!
Examine The Qualstar Outline

Ready? Set? Go! and feel the high energy of this popular and exciting course.

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

Related articles

• 2014 GMP Training Recommended: The Qualstar Simulation (drughealth.blogspot.com)
• Once Again, Lack of SOP Compliance Tops List of 483 Observations - BioProcess Blog (drughealth.blogspot.com)