PDA Letter Article

The Two aspects of Visual Inspection: Process and Technology

by John Ayres, MD, Pharma Safety Solutions, LLC and Rob Miller, MS, Pfizer Inc.

A gloved hand holding a medicine vial over a lens. Within the lens is a map of the world.

We are very excited to announce the 2021 PDA Visual Inspection Forum will be held 14-15 April with an innovative virtual agenda and wide-ranging content. The forum will be comprised of two tracks: one with focused content related to the Process of visual inspection and the other centered around the Technology of visual inspection, each featuring presentations related to contemporary visual inspection topics by both industry and regulatory agency subject matter experts.

The Forum opens with the traditional, and always informative, regulatory overview presented by conference co-chair John Shabushnig and the U.S. FDA’s Rukman De Silva. After a live question and answer, the concurrent process and technology tracks will begin.

  • The process track will highlight topics such as:
  • Particle investigation best practices
  • Sources of particles case study
  • Enhanced test methods for visible particles
  • PDA survey of particles in flex containers
  • Quality metrics and data integrity for visual inspection
  • Bracketing strategy methodology

The technology track will showcase:

  • Accelerating the inspection journey, vaccine production case study
  • Qualification of deep learning AVI
  • Placebo vs. real product challenges
  • Requirements for small batch size medicines
  • PDA Task Force to consider AI
  • Other deep learning and AI topics

Each session will include pre-recorded topic introductions and presentations followed by a live Q&A. Attendees will have access to all recorded presentations both during the conference and after the forum has concluded. Ample opportunities will be available for session-specific discussions and informal chat-room conversations throughout the event.

The virtual conference format provides convenient access to hear from leading visual inspection experts with the added opportunity to revisit any of the presentations post event. We look forward to lively discussions and virtual networking opportunities during the Forum and hope you will join us to interact and discover what’s new in the visual inspection process space for this year.

You may also be interested in the two-day training on visual inspection through PDA’s Training and Research Institute (TRI) on the days preceding the Visual Inspection Forum. Like the Forum, this popular course will be virtual and offer the opportunity to review the regulations, science and practical aspects of implementing a visual inspection program. You will have the opportunity to learn and review topics critical to successful visually inspect and to discuss your unique inspection challenges.

More information on the training course, PDA 417.1 Introduction to Visual Inspection, 12-13 April is available online.

About the Authors

John AyresDr. John Ayres received his undergraduate degree in chemistry from Butler University then received his MD from Indiana University School of Medicine. He obtained his JD from Indiana University-Bloomington. For 15 years, Dr. Ayres served as the Health Hazard Evaluation physician and Sr. Medical Fellow, Product Safety Assessments for a multi-national pharmaceutical company. Dr. Ayres now provides limited consultative assessments on issues related to the clinical implications of product quality attributes and variability surrounding CQAs with biopharmaceuticals in addition to safety-related compliance matters. He currently serves on the USP Visual Inspection Expert Panel and PDA’s Scientific Advisory Board.

Robert MillerRob Miller has been with Pfizer Global Technology and Engineering, Sterile Injectables Technology as a subject matter expert and group leader in visual inspection since 2019. He is responsible for supporting Pfizer’s aseptic network with internal guidance and policy related to manual and automated visual inspection. In addition, he reviews site inspection processes for compliance and directs strategic initiatives to the Pfizer network. Prior to this he worked within Pfizer Global Quality supporting the sterile injectables network and responsible for internal policy associated with visual inspection. Rob has a BS in Electrical Engineering, an MS in Engineering Management and a Graduate Certificate in Applied Statistics.