2021 - Quality and GMP Compliance for Virtual Companies (Pharmaceutical and Biologics Industries)

Day 01(11:00 AM - 5:00 PM EDT)
11.00 AM: Session Start
Introductions and participant expectations for the program
Fundamentals of Good Manufacturing Practice
What is GMP?
Purpose of GMP
Basis in law: US, Europe, Canada
Elements that apply to all virtual companies
Elements that depend on how operations are conducted: How to tell what applies to your company
Data Integrity: What it is and why it is important to GMP
Fundamentals of Good Clinical Practice (GCP)
What is GCP?
Purpose of GCP
Basis in law: US, Europe, Canada
Elements that apply to all virtual companies
Elements that depend on how operations are conducted: How to tell what applies to your company
Regulatory and business risks: The case for compliance
Virtual company organizational structure and responsibility for QA/GMP/GCP
Virtual company quality system structure and management
Policies, procedures, documentation management
Metrics and management review considerations
Selection, qualification and monitoring of contractors
Initial due diligence – public information sources to gage compliance
Qualification of vendors
Quality agreements – determining and documenting responsibilities for GMP
Vendor audit program
Day One Q&A and recap of progress meeting stated course expectations
Day 02(11:30 AM - 5:30 PM EDT)
Regulatory Inspections
Purpose of an inspection
Reasons for inspections
Inspections at virtual company headquarters locations – purpose and scope
Inspections at CMOs and Contract Labs
GMP inspections versus Preapproval inspections – FDA
GCP inspections of sponsors of clinical trials
EMA inspections – contrast with FDA
Health Canada inspections
Logistics for managing inspections at your location
Information sources about inspections on agency web sites: What you need and how to find it easily
Preparation for inspections
Overall process – ready room support
Receiving and hosting the inspectors
Providing documents
Answering questions
Interpersonal dos and don’ts for interacting with inspectors
Managing the exit discussion at the conclusion of the inspection
Inspections at your contract organizations
Making sure your CMO and contract lab are “PAI ready”
Training employees to assure inspection readiness – pitfalls to make sure you avoid
Conducting mock inspections effectively
Post-inspection communications with the inspecting agency
How to write an effective response
Common mistakes to avoid
Following up to ensure the response is satisfactory
When to request a meeting, and if granted, how best to handle it
Enforcement considerations
FDA enforcement process – domestic and ex-US
EMA enforcement
Health Canada
Final Q&A, discussion, and conclusion
4:30 PM: Adjourn