Session 1

• Introduction – Why cGMPs and Validations? Why a risk-based approach is necessary for OTC drug manufacturers and 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
• Discussion of a Comparison Matrix between Cosmetic GMP Guidelines and focus versus drug GMP Regulations
• 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

                                                          DAY TWO

Session 1

• Process Transfer documentation – define critical steps and parameters
• 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
• 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 critique procedures to be provided in terms of their compliance with cGMP’s and current industry standards

Session 4

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