FDA FastStats: A Look Back at all FDA 483 Inspectional Observations for Fiscal Year 2014 - AssurXblog

View the chart & read the full article:  FDA FastStats: A Look Back at all FDA 483 Inspectional Observations for Fiscal Year 2014 - AssurXblog:

". . . FDA 483 Inspectional Observations for Fiscal Year 2014. 483s increased in foods from the prior fiscal year to 2476, an increase of 3.8%. However, medical devices and drugs were down -11.6% and -6.5%, respectively, from FY 2013. Interestingly, medical device 483s bucked their recent upward trend with the lowest number of observations since FY 2009."

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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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About Training for GMP Trainers - Enhance Your Skills

Updated December 19, 2025

You might also be interested in our online version of the course:

GMP Trainer Awareness, Certification, & Master Trainer Course. This online self-study course leads participants through many different ways to teach cGMPs and QSRs. Learn how your class instructor thinks about delivering a training session to students, so you can repeat that training approach in your own organization.

--- original post follows below  ---

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 May 5-9, 2014 GMP Trainer Certification Public Seminar in Fort Lauderdale, FL.
GMP-QSR Trainer Certification Public Seminar by SkillsPlus International Inc.

 

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Recommendations for 2014 GMP Training - Executive Session: What Leadership Needs to Know

 

483 Observation Gotchas!

 

1. Firm lacked an effective training program to ensure all employees, including upper management, are fully trained on CGMPs.

2. Management failed to prevent non-controlled documents from being in the dispensing area.

3. Management did not understand their role & responsibility in supporting & enforcing the quality system.   

 

 

Planning for Training 2014!

 2014 is just around the corner! 

1. Can't get management staff to attend your CGMP training sessions, or
2. Not quite sure what to present to management staff for annual CGMP training, or
3. Does management feel that they do not need to attend annual CGMP training?

If you answered "Yes" to one or more of these questions, then you need to take a look at our Executive Session 2014 CGMP Update.

Learn More About the SkillsPlus Executive Session 2014 CGMP Update Course

  

 

Featured Course

Executive Session 2014 CGMP Update: This course focuses on what the executive needs to know. There's no discussion of "single-line through ... yada, yada, yada," in this course.

 

Topics addressed in this intense update:

1. Annual observation update

2. What the observations mean to executives and managers

3. Consequences

4. Interesting court cases

5. Current trends and more!

 

If your firm needs to get some of your executives and managers into meaningful CGMP training, then you need to look into our Executive Session 2014 CGMP Update!

Examine The Executive Session Outline

 

Allan Dewes, President.

 

About Your Instructor

Allan Dewes

Allan Dewes has been training CGMP for over 30 years, including managers and executives. Allan knows how to adjust his comments and focus on the needs of executives and managers.

Email today to request a quotation

 

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2014 GMP Training Ideas - GMP Olympics Refresher Course

Updated September 26, 2022

The GMP training course described in the original post is no longer offered.

People also search for:

FDA GMP online training programs and classes offered by SkillsPlus International Inc.

---  the original post follows below  ---

Plan for cGMP Training 2014!  2014 is just around the corner!  Do your employees avoid CGMP training, claiming they've heard it all, or Do they resist attending CGMP training because "their" job is never discussed, or Do some employees "drift off" in CGMP training because it is too theoretical? If you answered "Yes" to one or more of these questions, then you need to take a look at our GMP Olympics Refresher course.

Featured Course GMP Olympics 2014: Become a participant in the Olympics! This course challenges even the most seasoned employee's knowledge of CGMPs. This course is definitely not for new employees who are new to the industry. Activities from this highly interactive workshop: 1. Heard on the Street 2. Team-based regulation review 3. GMP Challenge 4. Inspection Detection, and more! This course can be customized to meet a variety of content and time constraints. Examine the GMP Olympics 2014 Course Outline About Your Instructor Allan Dewes    Allan Dewes has been training employees for over 40 years, with 30 years in the pharmaceutical industry. Allan understands CGMP regulations, the FDA expectations, and how to make training fun to maximize retention. Email today to request a quotation

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

2014 GMP Training Recommendation - Root Cause for Deviation Investigations Workshop

Do your firm's   Planning for Training 2014!  2014 is just around the corner!  Do your firm's investigations conclude no assignable root cause, or Do your firm's investigations conclude the root cause was human error, or Do your investigations fail to identify product impact? If you answered "Yes" to one or more of these questions, then take a look at our Root Cause for Deviation Investigations workshop.

 

Featured Course Root Cause Analysis of Deviations: This course is more than idle chat. In this workshop, students apply root cause analysis tools to real in-plant deviations.   Tools addressed in this very popular workshop: 1. 5-Whys In-depth Map 2. Sequence of Events 3. Distinctions 4. Walk Through Analysis 5. Change Analysis 6. Control Barrier Analysis 7. Fishbone Diagrams and more!   If your firm is not satisfied with the quality of deviation investigations, then you need to look into our Root Cause Analysis of Deviations workshop!   Examine The Root Cause Analysis - Investigation of Deviations Outline      Allan Dewes, President.   About Your Instructor Allan Dewes Allan Dewes has worked on deviation investigations and trained others to do the same for over 30 years. Allan understands CGMP regulations, the FDA expectations, and how to make deviation training effective and fun.   Email today to request a quotation

 

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GMP Training - Plan For Next Year

• Buy now! FDA GMP online training courses offered by SkillsPlus International Inc.

Updated December 19, 2025

---  the original post follows below  ---

Planning for Training 2014!

 2014 is just around the corner! 

1. Do CGMP documents contain many errors, or
2. Are change controls often side-stepped, or
3. Is the Quality Unit often side-stepped, or
4. Are procedures not always followed?
   
   If you answered "Yes" to one or more of these questions, then take a look at our 2014 Qualstar: A CGMP Training Simulation course. 

Featured Course (this course has been discontinued)

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!

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