Training #1 GMP master class – get it right to avoid compliance issues (12 hrs)

Course Agenda

GMPs – Government Regulations

• What are the regulations governing Good Manufacturing Practices?
• Your responsibilities
• Pertinent GMP topics as per the code of Federal Regulations
• Quality Management
• Personnel
• Premises and equipment
• Documentation
• Production
• Quality Assurance
• Materials management
• Production and in-process controls
• Packaging and labeling
• Storage and distribution
• Laboratory controls
• Validation
• Change control
• Rejection and re-use of material
• Complaints and recalls
• Supplier controls

GMP Inspections

• Preparing for a GMP Inspection
• The consequences of not being ready
• The specific areas that are inspected during a GMP inspection

FDA Inspection Tips and Recommendations

• The FDA Inspection – how is it structured and conducted
• Responding and organizing for the FDA Inspection
• Importance of truthfulness
• Importance of knowledgeability and confidence
• FDA Tricks to elicit information
• Arguing and challenging
• Behavior during the inspection
• Importance and role of documentation
• Effective communication skills
• Being deceptive
• Opinion versus fact
• Phrases never to say
• Handling adverse findings during the inspection

Training #2 GCP/GLP/GMP : Comparison and Understanding of the FDA’s 3 Major Regulations (1.5 hrs)

Agenda

• FDA Guidance and Standards
• Major Misconception
• Overview of each regulation – GCP, GLP, GMP
• How each regulation is the same
• How each regulation differs
• FDA’s interpretation of each regulation
• Regulations and Requirements for each

Training #3 cGMP Training on FDA Inspections

Session 1:

U.S., EU, and Japan GMPs - Status of Harmonization& Future Trends

• Current status of harmonization of GMP requirements
• Future Trends

Where Inconsistencies Become a Problem: WHO, ICH, Countries

• Discrepancies in global expectations
• Alignment issues

Key Chapter Reviews

• ICH GMP organization
• Category reviews

Compliance with ICH Guidelines for GMPs

• Understanding and Insight into Healthcare Authority expectations
• How GMP requirements/inspections can differ from a single ICH Standard
• How regulators (from 3 regions) will assess/enforce compliance with Q7

Session 2:

APIs

• Auditing API facilities
• Typical audit agenda
• ICH Area differences

Finished Products

• Auditing finished product facilities
• Typical audit agenda
• ICH Area differences

Excipients

Sterile products

Biologics

Clinical Packaging

Session 3:

Area GMP Inspections

•  Differences in how GMP inspections are conducted.
• Areas of GMP inspection focus by area
•  Modifying your self-inspection systems to customized area concerns.

Outsourcing Management Regional Perspective on:

• Contract Manufacturing
• Contract packaging.
• 3rd Party Contract testing

Auditing Your Facilities for Global Considerations

• Importance of pre-audits to regional GMP focus.
• How to focus your internal audits on a US, EU, and Japan compliance system

Training #4 GMPs for MICROBIOLOGISTS — The Manufacturing Environment Webinar

To Gain an overall review of cGMP and those sections of 21 CFR 211 that impact microbiology within the Manufacturing environment

• Review USP, 21 CFR 211, EP, Canadian, ISO and various FDA Guidances that impact microbiological issues throughout the cGMP environment for the microbiologist within manufacturing/QC operations
• Determine how to control numbers/species of microorganisms within the manufacturing environment with disinfectants and antiseptics USP<1072>
• Review how to control water systems (PW/WFI) within a manufacturing environment
• Study how OOT, OOS and CAPAs impact all aspects of the microbiological environment
•  Review various Case Studies that involve Form FDA 483s and Warning Letters