Overview

The process to bring a drug to the commercial market involves a validation life cycle, which includes product and process design, facility and equipment qualification, process and product validation studies, and continuing evaluation. This course will provide an overview of the process, and suggest approaches that may be considered.

Why Should You Attend

To learn the required parts of a drug’s validation life cycle, and ways to satisfy the requirements of each component.

Learning Objectives

  • Understand what must be accomplished during EQ, IQ/OQ, PQ, and PV
  • Learn methods to assure smooth transfer from lab to production equipment
  • Learn approaches to establish correlation between development and production freeze dryers
  • Understand challenges of moving from non-controlled to GMP environments
  • Learn a QbD approach to product and process design and management
  • Learn post-validation approach for managing deviations during production activities

Webinar Takeaway

  • Dryer correlation
  • Tech transfer
  • Validation
  • Quality by Design
  • Deviation management 

Who Will Benefit

  • Professionals in Quality Control
  • Quality Assurance
  • Validation
  • R&D Groups
  • Biochemists
  • Pilot Plant Operators
  • Chemical Engineers
  • Production Supervisors
  • Chemists
  • Equipment Maintenance
  • Mechanical Engineers

The course will also benefit those in other departments who find lyophilization among their responsibilities.

FDA Faculty Lisa Hardwick Thompson

Faculty Lisa Hardwick Thompson 

Pharmaceutical Lyophilization Expert at Lyo Blackboard LLC

Nashville, Indiana, United States

Lisa Hardwick Thompson is a pharmaceutical technology consultant and educator with quality, regulatory, product/process development, and technical management experience at Cook Medical, Baxter, Catalent, and start-up businesses. During her career based in the pharmaceutical CMO sector, her expertise has been dedicated to the creation and/or transfer of clinical and commercial formulations and processes, specifically focused on lyophilized parenteral drug products. Her current role at Lyo Blackboard is devoted to consultation and education in the field of lyophilization.

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