OTC Drug and Personal Care Product GMP & FDA Regulation

Upon completion of this course, the participants will be able to:

• Describe the legal basis, regulatory control & industrial standards regulating the manufacture of various over-the-counter drug and personal care products.
• Compare and contrast GMPs requirements and industrial best practices for these products marketed in the US.
• Outline steps and tools to establish and implement an effective GMP/quality management system for these OTC products.
• Design a self-audit program and/or preparation plan for an FDA inspection.

Introductions & Agenda Review

Session 1. Introduction to Over-the-Counter Personal Care Consumer Products

• Terminology
• Product Types & Regulatory Categories
• Market trends & consumer behavior  
• Current affairs 

Session 2. Regulatory Review of the Control of Personal Care Products in the World

• Definition & classification:  drug or cosmetic or something else?
• Regulatory comparison & contrast

1. Drugs 
2. Cosmetics
3. Topical antimicrobials (FDA vs. EPA Perspectives)

• Relevant chemical control regulations

Session 3. Introduction to Pharmaceutical cGMPs

• Global quality system overview

1. Historical background
2. International legal basis
3. Global GMP trend watch
4. International harmonization

• Pharmaceutical quality system framework in the US

1. Quality system overview
2. Legal basis
3. Guidance to the industry

Session 4. US OTC Drug Regulation Highlights

• Historical/Current legislative development
• Legal definition & distinction
• Product classification standards
• Path to regulatory “registration”

1. OTC monograph
2. NDA path
3. What if you are a combination product?

• Manufacturing requirements

1. Control of PI
2. Safety & effectiveness control
3. Mandatory pharmaceutical cGMP compliance
4. FDA inspections

• Labeling/Advertising/Promotion rules
• Post market surveillance

1. Complaints & recalls
2. Roles & responsibilities
3. Follow-up & reporting responsibilities

• Import requirements

Session 5. Select FDA GMP Highlights

• Cosmetic & Personal Care Products GMP
• Other Relevant Chemical Control Regulations – A Global Review

1. TSCA
2. REACH

• Summary, Discussion & Case Studies

Session 6. The Dreaded FDA Inspection

• Definition
• Self-audit vs. regulatory inspection
• Self audit essentials
• Preparing for an FDA inspection
• Post FDA inspection measures

Session 7. FDA GMP Enforcement 

• Enforcement Statistics, Highlights & Focus
• Case studies
• Discussion, review, recap, questions & answers

Session 8. Global Current Affairs & Case Studies

• Existing & emerging issues

1. Quality, authenticity & counterfeit
2. Sourcing & supply
3. Tracking & inventory
4. Efficiency management
5. Relevant chemical control & management

"Compared to courses by other providers this was much better and more comprehensive. The supporting case studies kept the audience fully engaged. The course director was very experienced and delivered interesting real-life examples."

Ruben C., Director of Quality, Universal Beauty Products

"The experience of the Course Director was critical to this great course! She added excellent insight. The case studies were very enjoyable."

Carl R., Supplier Quality Compliance Manager, Clorox

"The Course Director took time to answer questions throughout the course. The discussion opportunity this provided was very beneficial."

Tammy V., OTC QE, Dow Corning Corporation

"A well-organized, thorough, well-paced overview of VMP, cGMP and validation requirements presented in a manner that anyone could understand. Well done!"

Kirk J., Corporate Engineering Manager, Alberto Culver

"The Course Director kept the course interesting. She was extremely knowledgeable and answered all questions to the point."

Shiv R., Sr. Scientist, J&J

"The Course Director was knowledgeable and presented the material well."

Eileen M., QA/QC Manager, Arkema, Inc.