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2020 PDA Visual Inspection Interest Group Workshop

Sep 23, 2020
Bethesda, MD

  • Interest Group
  • The Americas

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Overview

A one-day meeting on visual inspection will be held in Bethesda, MD, 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

    7:30 a.m. - 12:15 p.m.
    Registration Open

    8:30 a.m. – 10:30 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.  will 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

    8:30 a.m. – 8:40 a.m.
    Welcome and Introduction of Workshop
    John G. Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC

    8:40 a.m. - 10:30 a.m.
    Group Discussion

    9:45 a.m. – 5:15 p.m.
    Exhibit Area Open

    10:30 a.m. – 11:15 a.m.
    Refreshment Break in Exhibit Area

    11:15 a.m. – 12:15 p.m.
    P2: Summary of Discussion from the 2020 PDA Visual Inspection Forum
    Moderator: John G. Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC

    This session will bring highlights from this year’s VI Forum held in Berlin in April. 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

    11:15 a.m. – 11:25 a.m.
    Forum Summary
    John G. Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC

    11:25 a.m. – 12:15 p.m.
    Group Discussion

    12:15 p.m. – 1:30 p.m.
    Networking Lunch

    1:30 p.m. – 3:00 p.m.
    P3: Application of Novel Technology in Visual Inspection
    Moderator: Richard (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

    1:30 p.m. – 1:40 p.m.
    Novel Technology Overview
    Richard (Rick) Watson, Director, Sterile & Validation COE, Merck & Co., Inc.

    1:40 p.m. - 3:00 p.m.
    Group Discussion


    3:00 p.m. – 3:45 p.m.
    Refreshment Break in Exhibit Area

    3:45 p.m. – 5:30 p.m.
    P4: Panel Discussion
    Moderator: Richard (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

    3:45 p.m. – 4:00 p.m.
    Introduction
    Richard (Rick) Watson, Director, Sterile & Validation COE, Merck & Co., Inc.

    4:00 pa.m. – 5:15 p.m.
    Panel Discussion

    5:15 p.m. – 5:30 p.m.
    Closing Remarks and Final Wrap-up
    John G. Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC


Highlighted Speakers

John G. Shabushnig
John G. Shabushnig
Insight Pharma Consulting, LLC

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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Travel

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

4350 East West Highway, Suite 110
Bethesda, MD

How to Get Here

By Air

Reagon National Airport (DCA) is approximately 13 miles away from PDA and all major carriers service this airport. Two other airports in the vicinity are both serviced by all major carriers: Dulles International Airport (IAD), is 27 miles away, and Baltimore-Washington International Airport (BWI), 35 miles away.

Taxi fares from DCA are approximately $60 one way, not including tip. One way taxi fares from IAD is approximately $75 and $80 from BWI.

By Car

PDA is located within 4350 Bethesda Towers, which is to the left of and across from Bethesda-Chevy Chase High School.

There is a parking garage located at the PDA location. The fee is $12/day. Please do not leave your car in the parking garage past 6:00 p.m. as both the building and parking garage access doors are locked.

Other Options

Metro – Ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to PDA.

Amtrak – Ride Amtrak and depart at Union Station. From Union Station, ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to PDA.

Directions

Registration Fees

Regular Price
Registration Type  
Member $750
Non-member $950








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

† You must be a member to receive this rate.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Group Registration Discount

Register 3 people from the same organization as a group (at the same time) for the Conference or Workshop and receive the 4th registration free. Other discounts cannot be applied.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact [email protected] or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent by Aug 25, 2020, no fee will be charged. After Aug 25, 2020, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent by Aug 25, 2020, a full refund will be given minus a $200 fee. After Aug 25, 2020, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to [email protected]. Phone messages are not accepted.

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