PDA 211.2 Quality and Compliance Management for Virtual Companies
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Many biotech companies and some pharma companies today are small, “virtual” organizations that outsource most GxP-governed activities such as clinical trials, manufacturing, packaging, laboratory testing, and drug safety monitoring. Such companies often lack in-house knowledge of GCP, GLP and GMP requirements, or have such knowledge vested in very few people. The prospect of an FDA inspection can be a daunting one, as can ensuring that your vendors will pass FDA scrutiny.
This live eLearning training course will help you understand what you need to have in place, what the high-risk areas are, and how best to manage those risks as you grow and bring activities in-house. This training course explains the GMP, GCP and GLP responsibilities of virtual companies or others who predominately outsource GxP-governed activities.
- Explain GMP and GCP requirements for virtual companies
- Decide which elements of your quality system should be managed in-house and how
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Standard Pricing
Standard Member Price
$599GovernmentMember Only
$599
Health AuthorityMember Only
$599
Early Career ProfessionalMember Only
$599
StudentMember Only
$599
AcademicMember Only
$599
Non-Member
$599
Day 1
Virtual Company Challenges and the Business Case for GXP Compliance
Introduction to FDA Law, Regulation and GXP Concepts
Steps to Building a GXP Quality System in a Virtual Company Setting
Quality Agreements, Vendor Qualification and Auditing: Best Practices
Day 2
Phase Appropriate GMP Compliance Considerations
Data Integrity: A GXP-Wide Concept
FDA Inspections: FDA Authority, Logistics, Effective Ways to Respond to Questions; The 483 and Beyond
Summary and General Q&A
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