Effective Risk-Based Applications of cGMPs for Cosmetics and OTC Drug Products

This two-day course is designed for those who manage, audit or oversee manufacturing of cosmetic and OTC drug products (no dosage). It will also be beneficial for those involved in Quality Systems and/or those assigned with quality unit responsibilities at manufacturing facilities.

This includes, but is not limited to, professionals in Research and Development for the Process and Analytical procedures, Quality Control, Quality Assurance, Manufacturing, Engineering and Validation groups. The course will also benefit those in other departments who will interact with the Manufacturing and Quality functions at the facility.

Learning Objectives

Upon completion of this course attendees will have a clear understanding of regulatory agency expectations for the manufacture of Cosmetic Products in comparison to OTC Drug requirements. Additionally, participants will gain the background knowledge necessary to effectively implement good manufacturing practices and controls within their operation including the application of the validation requirements. Attendees will understand how to apply a risk-based approach for planning and implementing GMP/Quality systems, as well as, refining procedures within the validation program by addressing areas/systems with the highest impact on product quality.

Those attending will also learn how to apply the family product grouping approach to simplify validation procedures while maintaining compliance and developing a long-term quality program.

Course Description

This course provides the tools for risk-based implementation and continuous compliance with cGMPs for OTC drug products produced by cosmetic manufacturers. The course also covers regulatory expectations as contained in U.S. and International guidelines. This training prepares attendees to assess their current compliance status, develop strategies and plans for remediation of identified gaps and execute a plan to achieve compliance by initially addressing higher risk items within a reasonable time frame. There will be an opportunity to apply what you have learned in during two workshops.

In addition, ample time will be provided to address specific problems and questions of individual participants.

Additional benefits of this class include:

• All participants receive a Resource CD with Key Guidance Documents, Quality/Validation Procedure templates, a Validation Master Plan template and Protocol templates.
• Participants will also have the opportunity for one-on-one consulting with the course director during course breaks and in the evenings.

________________________________________

COURSE AGENDA

DAY ONE

Session 1

• Introduction – Why cGMPs and Validations? Why a risk-based approach is necessary for cosmetic manufacturers producing OTC drug items?
• What are your top cGMP compliance and validation questions, problems, and issues?
• U.S. and International Regulations Pertaining to Cosmetics and OTC Drug Products (No Dosage) commonly produced by Cosmetic manufacturers
• Key FDA and International Guidance Documents
• Quality Systems requirements – new FDA guideline

Session 2

• How to conduct an Assessment of your current compliance status
 Procedures for Quality Functional Responsibilities
 Production/Process Controls
 Non-Conformances
 Change Control
 Validation
• How to Plan/Organize the process to develop/revise/review current procedures to assure an adequate level of compliance
 How to establish priorities – define key systems using a risk-based approach
 Training Program – is it effective and adequately documented?
 Prepare for Validation
• Workshop - Participants will have the opportunity to review a list of procedures necessary for cGMP/Validation and prioritize the items on the list.

Session 3

• How to structure a Validation Program
• The Validation Master Plan – Why and How to effectively use this document
• How to Apply Product Grouping Concepts and the overall flow of the program implementation based on risk and impact concepts

DAY TWO

Session 1

• Process Transfer documentation – define critical steps and parameters
• Method Transfer documentation – validation versus verification of validated methods
 Analytical Equipment Qualification
• How to qualify Utilities (Water, Gases) – direct impact systems
• How to select/prioritize Processing Equipment/Systems to be Qualified – direct impact on product quality
• How to develop a Cleaning Validation Strategy
• How to address Computer Systems and Part 11 Applications
• Validation Maintenance – How to keep your program

Session 2

• cGMP and Validation at work – Case Studies
• Review of Recent Validation Related 483s and Warning Letters – related to OTC Drug products by Cosmetic manufacturers
• Detailed discussion of participant questions, problems, and issues
• Preparing for an FDA Inspection

Session 3

• Workshop - Participants will have the opportunity to create and critique validation plans for case study applications to be provided

Session 4

• Question and Answer Session
• Course Wrap-up and Conclusions