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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Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
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Report On The State Of Pharmaceutical Quality - FDA.gov

• FDA cGMP QSR GMP Online Training Courses by SkillsPlus International Inc.

Center For Drug Evaluation And Research - Office Of Pharmaceutical Quality

Report On The State Of Pharmaceutical Quality - FDA.gov

Assuring quality medicines are available for the American public


The report is a good read.  It's data-rich, and provides a good overview.

This comes from the report's introduction:

"The Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER) in the U.S. Food and Drug Administration (FDA) monitors the quality of CDER-regulated drugs legally marketed in the U.S. A quality drug is consistently safe and effective, free of contamination and defects. Patients and consumers expect quality drugs with every dose they take. The ‘State of Pharmaceutical Quality’ is a yearly snapshot of the pharmaceutical manufacturing industry’s ability to deliver quality pharmaceutical products."

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Major shift ahead in how FDA regulates drug quality: PwC

• Recommended FDA cGMP online training programs and courses by SkillsPlus Intl Inc.

Updated June 27, 2022

The link to the original source article broke.

---  the original post follows below  ---

FDA Drug Quality Report - Major shift ahead in how FDA regulates drug quality: PwC:

"Parts of the pharmaceutical industry continue to struggle with drug quality. A major shift in the way the FDA oversees drug quality could pose new challenges for companies with inadequate control over their manufacturing facilities and supply chains."

'via Blog this'

Read the PwC report:
Major shift ahead in how FDA regulates drug quality (PDF)

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- - -

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Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
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Ideas For 2014 GMP Training - Deviation Investigation Report Writing Clinic

483 Observation Gotchas!

 

1. Deviation reports failed to include a discussion of product impact.

2. Investigation reports stated this was an isolated incident, yet the database revealed 13 similar incidents.

3. Investigation reports failed to provide data to support the root cause determination

 

Planning for Training 2014!  2014 is just around the corner!  Do your investigation reports wander all over and never get to the point, or Do deviation reports fail to document a sound root cause conclusion, or Do deviation report writers never seem to know what Quality Assurance wants discussed in the report? If you answered "Yes" to one or more of these questions, then take a look at our Investigations Report Writing clinic.

 

Featured Course Deviation Investigation Report Writing Clinic: This course is hands-on and personal. In this clinic, students: learn about each section of your company's investigation report; write each section of the report for a real investigation report, and then; receive personal coaching privately from Allan. This course is not the typical spelling and grammar checking training program often offered.   Common sections addressed in this very popular workshop: 1. Deviation Description 2. Previous Related Investigations 3. Product Impact Assessment 4. Root Cause Investigation Discussion 5. Root Cause Determination 6. Risk Assessment 7. Corrective and Preventive Actions and more!   If your firm is not satisfied with the quality of deviation investigation reports, then you need to look into our Deviation Investigation Report Writing Clinic!   Examine The SkillsPlus Investigation Report Writing Clinic Outline

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Stop Blaming The Same Old "False" Root Causes

Updated May 19, 2022

Now offered as an online training program!

View advanced cGMP training courses taught by SkillsPlus International Inc.

---  the original post follows below  ---

Pinpointing the wrong cause (for example, a "false" root cause) can result in ineffective immediate, corrective, and preventive actions.

• Throwing fixes at the wrong things might not fix the problem.
• Blaming and overusing human error as the root cause can result in incomplete and ineffective root cause analysis.

By taking our courses, you'll more confidently identify the real root causes, and craft clearer and more concise investigation reports.

.

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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FDA 483s Can Form Basis of Class Action Lawsuit

• Trusted FDA cGMP online training programs and courses offered by SkillsPlus Intl Inc.

In the long list of things that are inadvisable to regulatory professionals, making misleading statements to the authority in charge of regulating your business likely ranks near the top. Those found to have misled the U.S. Food and Drug Administration (FDA) have in the past been publicly warned, fined, imprisoned, shut down and barred from participating in federal programs.

Now KV Pharmaceuticals is facing the prospect of an additional action: a class-action shareholder lawsuit as the result of an FDA inspection report. This is an important event, and here's why . . .

Judge: Regulatory Inspection Report Can Form Basis of Class Action Lawsuit - RAPS - News - Article View:

"On Monday, 4 June a federal appeals court ruled a securities fraud class action lawsuit could proceed against pharmaceutical manufacturer KV Pharmaceuticals for purportedly causing $1.5 billion in shareholder losses after first misleading FDA about manufacturing problems at a facility and later shutting down the facility’s manufacturing operations."

'via Blog this'

What's important to note is that this decision is a marked reversal from existing precedence, which has found Form 483 reports to be immaterial to federal securities law.

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Deviation Investigation Reports - Training Class

Updated November 16, 2025

You might also be interested in:

Root Cause Analysis and Investigation Report Writing - Online Self-Study

You asked for it, so we delivered!

The most popular class with Allan Dewes, "Root Cause Analysis and Investigation Report Writing" is now available as an online self-study course. In 3-1/2 hours you'll learn about the tools used to conduct a thorough deviation investigation. You'll also learn great tips and get clear guidance on how to write a deviation investigation report. This class is not just theory and offers clear examples. Private email-based coaching is also available.

Learn more and buy:  Root Cause Analysis and Investigation Report Writing - Online Self-Study (by SkillsPlus International Inc.)


- - -  original post follows below  - - -

GMP Training - Deviation Investigation Reports - cGMP Training

Many FDA observations are caused by failures in deviation management and CAPA.

We can help you in this area, through this course:
Deviation Investigation Reports - a SkillsPlus Intl Inc. training class

This class teaches students how to use the data collected in an investigation to write a report and answer management and FDA questions.

After completing the class, students will be able to:

1. Increase investigation report suitability for FDA review. 
2. Decrease the number 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.

This class is energizing and exciting, and uses the following teaching approaches:

• In-house deviation reports will be used to demonstrate and practice the skills and principles of this class. 
• This course is best taught in a computer lab. We can ship computer labs to your site if needed. 
• 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.

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