Drug Master Files (DMFs) — Understanding and Meeting Your Global Regulatory and Processing Responsibilities
Master Drug Master File creation, submission, and lifecycle management — navigate FDA and EMA requirements, protect proprietary information, and maintain global regulatory compliance.
Instructor
Charles H. Paul
President, CHP Consulting LLC — Regulatory Compliance & Operational Excellence
What You'll Learn
About the event
About this event
Drug Master Files (DMFs) play a pivotal role in the pharmaceutical industry as confidential documents containing detailed information about the manufacturing, processing, packaging, and storage of APIs, excipients, and other essential drug product components. A DMF serves as a comprehensive regulatory submission, allowing companies to protect proprietary information while still complying with regulatory requirements.
This 90-minute webinar provides a thorough understanding of DMFs — their types, creation, submission process, global regulatory responsibilities, and lifecycle management. The session covers FDA and EMA requirements, practical documentation pitfalls to avoid, and how to ensure data integrity throughout the DMF lifecycle.
Code: FDB3663
Curriculum
Requirements
- QA, QC, Regulatory Affairs, R&D, Manufacturing, and Operations professionals
- Applicable to all personnel involved in the creation, use, and management of drug master files
Meet Your Instructor
Charles H. Paul
President, CHP Consulting LLC — Regulatory Compliance & Operational Excellence
Charles H. Paul is President of CHP Consulting LLC, a regulatory compliance, operational excellence, training, and technical documentation consulting firm supporting pharmaceutical, biotechnology, medical device, and advanced therapy organizations worldwide. With more than 30 years of experience in regulated manufacturing environments, Charles specializes in helping organizations build sustainable quality systems that support compliance, operational performance, workforce effectiveness, and inspection readiness. His experience includes GMP quality systems, manufacturing operations, technical training development, process validation, deviation management, CAPA systems, operational excellence, documentation systems, and regulatory inspection preparation. Charles has supported organizations implementing new technologies, expanding manufacturing operations, establishing quality infrastructures, and preparing for complex regulatory inspections. He is a recognized author, speaker, and consultant who has delivered numerous webinars and seminars on GMP compliance, quality systems, human performance improvement, technical documentation, inspection readiness, and operational excellence throughout the life sciences industry.
Event Details
Format
Recorded Webinar
Duration
1.5 hours
Certificate
Included
Access
Lifetime
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