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.

For more options and/or related training courses, please visit the page(s) below.

PDA Quality and Compliance Training Courses

  1. Explain GMP and GCP requirements for virtual companies
  2. Decide which elements of your quality system should be managed in-house and how

Contact

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Standard Pricing

Standard Member Price

$599

GovernmentMember Only

$599

Health AuthorityMember Only

$599

Early Career ProfessionalMember Only

$599

StudentMember Only

$599

AcademicMember Only

$599

Non-Member

$599

See Qualifying Criteria for Member Types.

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

Agenda is subject to change.

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