Many life sciences teams struggle with:
Unclear MAH and contractor regulatory responsibilities
Weak quality agreements that fail under inspection
Poor oversight of raw data and records
Inadequate vendor qualification and audit follow-up
CAPA gaps across outsourced manufacturing and testing
Participants learn a structured, practical approach including:
Defining accountable roles across outsourced operations
Building defendable quality and technical agreements
Strengthening vendor qualification and pre-contract audits
Improving data governance and batch release oversight
Managing CAPAs, inspections, and ongoing compliance
This course gives professionals a clear, practical framework for managing outsourced facilities with stronger compliance, better oversight, and greater regulatory confidence.
Many life sciences teams struggle with:
Unclear MAH and contractor regulatory responsibilities
Weak quality agreements that fail under inspection
Poor oversight of raw data and records
Inadequate vendor qualification and audit follow-up
CAPA gaps across outsourced manufacturing and testing
Participants learn a structured, practical approach including:
Defining accountable roles across outsourced operations
Building defendable quality and technical agreements
Strengthening vendor qualification and pre-contract audits
Improving data governance and batch release oversight
Managing CAPAs, inspections, and ongoing compliance
This course gives professionals a clear, practical framework for managing outsourced facilities with stronger compliance, better oversight, and greater regulatory confidence.
FDA, EU GMP, Annex 16, and EMA expectations
MAH, QP, and contractor roles and accountability
Delegation limits for regulated outsourced activities
Vendor selection and qualification best practices
Pre-contract audits and expectation alignment approaches
CAPA prioritization, tracking, and effectiveness follow-up
MSA versus quality and technical agreement requirements
Documentation review and routine oversight models
Person-in-plant approaches and contractor management practices
Batch release responsibilities and raw data access
Data integrity, retention, and governance expectations
Inspection findings, CRLs, and prevention strategies
FDA, EU GMP, Annex 16, and EMA expectations
MAH, QP, and contractor roles and accountability
Delegation limits for regulated outsourced activities
Vendor selection and qualification best practices
Pre-contract audits and expectation alignment approaches
CAPA prioritization, tracking, and effectiveness follow-up
MSA versus quality and technical agreement requirements
Documentation review and routine oversight models
Person-in-plant approaches and contractor management practices
Batch release responsibilities and raw data access
Data integrity, retention, and governance expectations
Inspection findings, CRLs, and prevention strategies
Learn how to maintain regulatory accountability while strengthening oversight of CDMOs, contract labs, and outsourced partners.
Gain practical tools to evaluate delegation limits, batch release responsibilities, and documentation expectations across contractor environments.
Build stronger systems for vendor qualification, audits, CAPA follow-up, data governance, and inspection readiness.
Improve cross-functional control of outsourced manufacturing, testing, technology transfer, and partner performance.
Learn how to maintain regulatory accountability while strengthening oversight of CDMOs, contract labs, and outsourced partners.
Gain practical tools to evaluate delegation limits, batch release responsibilities, and documentation expectations across contractor environments.
Build stronger systems for vendor qualification, audits, CAPA follow-up, data governance, and inspection readiness.
Improve cross-functional control of outsourced manufacturing, testing, technology transfer, and partner performance.
Karen Taylor is a highly respected GMP and quality systems consultant with more than 30 years of industry experience supporting global pharma and biotech companies in inspection readiness, regulatory strategy, computerized systems compliance, and data governance. She is also an award-winning international speaker known for translating complex GMP changes into practical, real-world guidance.
Areas of expertise: • GMP • Quality Systems • Inspection Readiness • Computerised Systems • Data Governance • Regulatory Strategy • CMO Audits
More than 30 years in pharma and biotech consulting
Supported startups and global companies through inspections
Co-founded PDA interest group on outsourced operations
Multiple speaker of the year award recipient
Karen Taylor is a highly respected GMP and quality systems consultant with more than 30 years of industry experience supporting global pharma and biotech companies in inspection readiness, regulatory strategy, computerized systems compliance, and data governance. She is also an award-winning international speaker known for translating complex GMP changes into practical, real-world guidance.
Areas of expertise: • GMP • Quality Systems Inspection • Readiness • Computerised Systems • Data Governance • Regulatory Strategy • CMO Audits
More than 30 years in pharma and biotech consulting
Supported startups and global companies through inspections
Co-founded PDA interest group on outsourced operations
Multiple speaker of the year award recipient
Interactive sessions with real-time Q&A and expert guidance
Two intensive sessions: 10:00-13:30 EST each day
4 sessions of 3 hours each
Review sessions and reference materials at your own pace
Yes. The course addresses FDA expectations as well as key EU requirements, including EU GMP Chapter 7, Annex 16, and relevant EMA expectations. Participants gain a practical view of how these frameworks apply to outsourced operations.
No. It is highly relevant for pharma, biotech, vaccine, and ATMP organizations, as well as service providers such as CDMOs and contract laboratories. The principles also apply broadly to regulated outsourced activities.
No prior deep expertise is required. The course is valuable for both professionals new to contractor oversight and experienced teams looking to strengthen compliance and inspection readiness.
Yes. Participants receive practical implementation materials, including a CDMO audit agenda example and guidance related to inspection management and follow-up. These tools are designed to support immediate application.
