2020 PDA Visual Inspection Interest Group Workshop

The regulatory environment for pharmaceutical manufacturing constantly evolves. We continue to look at current hot topics in the regulations that govern visual inspection and particle control and recent and proposed revisions to these requirements. EMA Annex 1 and the European Pharmacopoeia (EP) provide this guidance in Europe and Food and Drug Administration (FDA) and The US Pharmacopia (USP) provide this guidance in the United States. Both regions have been actively revising their regulations and guidance on these topics. We will discuss:

• FDA Recalls and Guidance
• USP <1790> Visual Inspection of Injections
• EMA Annex 1 Manufacture of Sterile Products
• EP 2.9.20 Particulate Contamination: Visible Particles
• EP 5.17.2 Recommendations on testing of particulate contamination: visible particles

10:00 a.m. – 10:10 a.m. | Welcome and Introduction of Workshop
John G. Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC

10:10 a.m. – 10:40 a.m. | Visual Inspection Regulatory and Compendial Update
John G. Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC

This session will highlight topics that will be covered at this year’s VI Forum held in Berlin in October. Key topics from this meeting will include:

• Particle identification, reduction and defect prevention
• Experience with difficult to inspect parenteral products (DIP)
• Advances in Automated Inspection
• Application of Artificial Intelligence (AI)/Deep Learning (DL) to automated inspection

11:40 a.m. – 11:50 a.m. | Forum Highlights
John G. Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC

This session will discuss novel technologies that are expected to deliver a positive impact on visual inspection processes.  The discussion will include examples of current advancements and consideration of likely future direction for application of these new technologies. Topics that will be discussed include:

• Use of Smart Glasses to enhance manual inspection 
• Applications for VR technology
• Advances in Artificial Intelligence (AI) in automated inspection
• How you prepare for Artificial Intelligence (AI)/Deep Learning (DL) and how to validate these systems

12:10 p.m. – 12:20 p.m. | Novel Technology Overview
Rick Watson, Director, Sterile & Validation CoE, Merck & Co., Inc.

This session will provide the opportunity to discuss topics of specific interest to those attending the workshop that were not addressed in the earlier sessions. This will be a good opportunity to:

• Discuss current challenges
• Benchmark with peers
• Discuss current regulatory and compliance environment and experience
• Identify useful references and resources

12:35 p.m. – 12:50 p.m. | Regulatory Considerations for the Assessment of Visible Particulates
Rukman S. De Silva, PhD, Chemist/Product Quality Reviewer, CDER, U.S. FDA

12:50 p.m. – 1:50 p.m. | Panel Discussion
Rukman S. De Silva, PhD, Chemist/Product Quality Reviewer, CDER, U.S. FDA
John G. Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC
Romain Veillon, Senior Manager, Vision Inspection & Leak Testing MSAT – Manufacturing Technologies, GSK Vaccines
Rick Watson, Director, Sterile & Validation CoE, Merck & Co., Inc.

1:50 p.m. – 2:00 p.m. | Closing Remarks and Final Wrap-up
John G. Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC