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2020Visual-1988x680

2020 PDA Visual Inspection Interest Group Workshop

Sep 23, 2020
Online,

  • Conference
  • Workshop
  • Interest Group
  • Virtual
  • Online

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Overview

A one-day meeting on visual inspection will be held in virtually, on September 23, 2020. This format offers the opportunity for extended discussion on hot topics in the field of visual inspection. We have identified a limited number of topics for discussion to allow a thorough review and will also have a panel discussion to address additional topics of interest to those that attend. We will provide an overview of each topic and the issues which are of interest and concern. We will then discuss and develop possible solutions to these challenging issues.

Agenda

  • Wednesday, September 23

    10:00 a.m. - 11:35 a.m. | P1: The Changing Regulatory Environment for Visual Inspection
    Moderator: John G. Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC

    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

    10:40 a.m. – 11:35 a.m. | Group Discussion

    11:35 a.m. – 11:40 a.m. | Break

    11:40 a.m. – 12:00 p.m. | P2: 2020 PDA Visual Inspection Forum Preview
    Moderator: 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

    11:50 a.m. – 12:00 p.m. | Group Discussion

    12:00 p.m. – 12:10 p.m. | Break

    12:10 p.m. – 12:30 p.m. | P3: Application of Novel Technology in Visual Inspection
    Moderator: Rick Watson, Director, Sterile & Validation COE, Merck & Co., Inc.

    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.

    12:20 p.m. – 12:30 p.m. | Q&A

    12:30 p.m. – 12:35 p.m. | Break

    12:35 p.m. – 2:00 p.m. | P4: Panel Discussion
    Moderator: 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


Highlighted Speakers

Rukman S.  De Silva
Rukman S. De Silva
U.S. FDA
John G. Shabushnig
John G. Shabushnig
Insight Pharma Consulting, LLC
Romain Veillon
Romain Veillon
GSK Vaccines
Rick J. Watson
Rick J. Watson
Merck & Co., Inc.

Additional Information

  • Learning Objectives

    Learning Objectives

    Upon completion of this workshop, participants will be able to:

    • Understand the planned revisions to EC Annex 1 and the requirements for visual inspection and container integrity testing found therein
    • Understand the revisions to USP <1790> and the guidance on visual inspection which it provides
    • Discuss and evaluate the application of Artificial Intelligence (AI)/Deep Learning (DL) to automated inspection
    • Discuss and evaluate new technologies being applied to the visual inspection process
  • Who Should Attend

    Who Should Attend

    Departments:
    Engineering | Manufacturing | Packaging | Process Development | Quality | Technical Services | Validation

    Pharmaceutical/Biopharmaceutical Developers:
    Clinical Supplies | Parenteral Development | Process Development

    Inspection Equipment Suppliers:
    Applications Development | Machine Design | Sales

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Registration Fees

Regular Price
Registration Type Fee
Member $600
Non-member $879

* For this member type or discounted rate, online registration is not available and must be faxed in.

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