Comprehensive Overview of FDA Regulatory Compliance for Drug and Biotech Products

The course will give participants a thorough understanding of the fundamentals of FDA regulatory compliance for drug products.  

Upon completion of the course, attendees will:

• Understand the guidelines, philosophy, and practical approach to FDA compliance.
• Comprehend the key strategies to achieve compliance: use of outsourced assistance, internal audits, the drug development and approval process, Quality by Design, reliance on electronic submissions, remediation plans, and proper FDA communication.
• Have resources for reference and updates on the latest regulations.

1. Introduction

• FDA delegated authority and powers
• FDA compliance: regulations, guidelines, internal agency controls
• FDA enforcement

1. 483s
2. Warning letters
3. Consent decrees
4. Seizure
5. Recalls

2. Interpreting Regulations

• Review of applicable regulations
• FDC ACT
• CFR

1. Establishing clear criteria
2. Establishing clear SOPs and policies
3. Managing the process

3. Audits and Outsourcing

• Auditor qualifications
• Use of contract support
• Internal auditing procedures and schedule

1. Key critical audit areas
2. Audit expectations of site personnel

• Staff training

4. Management Oversight

• Quality policy
• Management review

1. Escalation of issues to upper management
2. Communication, decision-making and transparency across management

• Resourcing

5. Navigating FDA

• Website review
• Investigator operations manual
• Compliance policy guides and program manuals

6. Emerging Trends at the FDA

• New compliance issues
• Drug shortage crisis
• Counterfeit drug issues and growing concerns
• Biosimilar approval pathways

7. Drug Development and Approval Process

• Drug development

1. QbD product development and design
2. Risk analysis
3. Post-approval changes to process, methods, etc.

• Regulatory filings

1. Key elements of IND, NDA/ANDA applications and FDA expectations
2. Electronic CTD format and content, most submitted through ESG (electronic submissions gateway)

• FDA review and approval process
• Post approval submissions

8. Successful Approaches to Compliance

• Internal auditing procedure and schedule
• Gap analysis

1. Regulations, guidances and procedures

• Remediation Plan

1. CAPAs
2. Change control process
3. Assignment of resources to correct issues

• Training procedure and curriculums
• FDA communication

1. Direct communication (emails,phone calls)
2. Recalls
3. Post approval submissions – Annual reports, ADE reporting

9. Summary

• Key issues
• Questions and resources

Highly Qualified Instructor

This workshop is led by Glenda Guest, an industry veteran with decades of hands-on regulatory experience in biotech and pharmaceuticals. Guest's expertise goes beyond compliance theory, having successfully navigated real-world FDA submissions and inspections from both the industry and agency perspectives.

"I have been provided with a better understanding of QA regulatory requirements, as they apply to my own processes. Also, I have acquired some ideas on how to implement audits within my group."

Cleo N., Quality Control Officer/Acting Team Leader, Los Alamos National Lab

"The course instructor was excellent. She has a wealth of knowledge and applicable examples to share with the class. She allowed the class to go off topic, but in relation to the course overall."

Sophia S., Manager Regulatory Affairs, Merrimack Pharmaceuticals

"Very engaging and knowledgeable instructor. Sharing of actual experiences and bench marking made the course educational and provided tools to improve compliance at my employer"

Jeffrey W., QA Compliance Specialist, Bristol Myers Squibb

"I am very, very happy with the depth and detail of information provided by the instructors. I also feel that I was given the tools to continue to educate myself effectively in FDA regulations. I will definitely recommend this group to others seeking FDA regulation training."

David G., Chemist, Blaine Labs

"The decision to attend the CfPIE course was one of the wisest decisions in my professional career. The Course Director was extremely knowledgeable and an expert in engaging attendees in the discussions. The subject matter was thoroughly covered. I would definitely recommend the course to others. I am looking forward to attending more courses with CfPIE. This course justified each and every dollar I spent on it."

Hiral K., QA Associates, Apicore Pharma

"I felt that the instructor tailored the class to the needs of the attendees and requested the needs up front, which was very helpful."

Karen K., Senior Director, Submissions & Product License Support, Pfizer

"The Course was well organized and supported well by the written material. The instructor was knowledgeable and illustrated numerous points by example. She appeared to be very current on FDA thinking."

William M., Livestock Vet. Manager, Pfizer Animal Health

"CfPIE has once again delivered a course of the highest standard. The instructor relayed her best knowledge of the pharmaceutical and biotech industries in a comprehensive and energetic manner. I look forward to attending further courses with CfPIE in the future."

Janet P., QCT, Pfizer

"This was and excellent class! The information gives you a very comprehensive overview of what the FDA requires. I was able to get more information from this FDA training class in two days than I have in all other training courses I have taken combined!"

Cory D., Associate Manager, Document Control, Cardinal Health – Oral Technologies

"Very informative course. The Course Director takes the time to answer client-specific questions which really helps drive the information home."

Claudia B., Senior Consultant, Tunnell Consulting

"Great introduction to the FDA inspection process and requirements from all perspectives. The Course Director's experience and knowledge is very applicable and evident."

Scott G., Senior Scientist, Shire Labs

"Presentation was clear and the Course Director showed a willingness to go beyond the material by giving real-life examples to help with understanding and clarification."

Monica S., Senior QA Auditor, Merck

"The Course Director was very informative. Her ability to give examples based on personal experience really enhanced my learning and understanding of the topics."

Kelli H., QA Manager, PharmaForm

"The course used numerous examples of personal experience and examples from FDA audits of biotech and pharma companies which was critical in effectively understanding FDA regulations, audits and quality systems. I have been able to make a direct comparison between my company's current quality systems and what the FDA expects to see. This has not only provided me with a degree of reassurance, but has also enabled me to think of new ideas. I intend to implement change within my own manufacturing department which will assist in the monitoring and control of current process and systems. The course has been very thought provoking and a fantastic refresher."

Angela S., Reagents Manager, Genzyme Diagnostics

"Our instructor was very knowledgeable and very encouraging. Communication was excellent and she cared that we understood the course materials."

Sarah V., Regulatory Affairs Compliance Analyst, Paddock Labs