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2018 PDA Visual Inspection Interest Group Workshop

Apr 25, 2018
Bethesda, MD

  • Interest Group
  • Western Hemisphere Events

Overview

A one-day meeting on visual inspection will be held in Bethesda, MD on April 25, 2018. This will be in addition to the usual sessions held as part of the PDA Annual Meeting and PDA/FDA Joint Regulatory Conference. This format offers the opportunity for extended discussion on hot topics in the field of visual inspection. Our current plan is to identify a limited number of topics for discussion to allow a thorough review. 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. We welcome your suggestions on topics of interest to you in advance of this meeting.

Learning Objectives

At the completion of this workshop, attendees will be able to:

  • Identify unique testing requirements for difficult to inspect products found in USP <790> such as suspensions, freeze dried powders, colored solutions, biopharmaceuticals with inherent particles and those products in non-transparent containers
  • Develop practical implementation strategies for automated inspection methods
  • Understand the current proposal to revise EC Annex 1 and the requirements for visual inspection and container integrity testing found there

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

Contact

Workshop Inquiries
Jason Brown

Assistant Director, Programs
(301) 656-5900 ext. 131
Email: brown@pda.org

Registration Inquiries
Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
Email: registration@pda.org

Exhibition Inquiries
David Hall
Vice President, Sales 
Tel: +1 (240) 688- 4405
Email: hall@pda.org

Agenda

  • Wednesday, April 25

    7:30 a.m. – 8:30 a.m.
    Continental Breakfast

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

    8:30 a.m. – 10:00 a.m.
    P1: Proposed Revisions to Annex 1
    Moderator: John G. Shabushnig, PhD,
    Principal Consultant, Insight Pharma Consulting, LLC. and Visual Inspection Interest Group Leader.

    Session Description: This session will look at the proposed revisions and additions to the Finishing of Sterile Products section in the recently released Annex 1 draft. This document, which governs sterile medicinal product quality in Europe, contains significant changes that may affect the way you inspect and test your products. Much has been added to this version. We will discuss:

    • What's changed / What's new
    • General visual inspection requirements
    • Manual inspection
    • Automated Methods
    • Trending Topics
    • Container integrity testing

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

    10:00 a.m. – 10:45 a.m.
    Refreshment Break in Exhibit Area

    10:45 a.m. – 12:15 p.m.
    P2: Difficult to Inspect Products and USP <790>
    Moderator: Rick Watson,
    Director, Sterile & Validation COE, Merck Co., Inc.

    Session Description: This session will be a focused discussion on implementation of visible particulate process controls to meet the USP <790> and <1790> guidance, with an emphasis on the challenges posed by DIP (Difficult to Inspect Product). Topics covered in this session include:

    • USP <790> and <1790> guidance
    • Considerations of particle criticality
    • Approaches for non-destructive and Destructive AQL testing
    • Application in customer complaints
    • Regulatory approach to manage changes
    • Upcoming guidance in PDA Tech Report for Difficult to Inspect Products

    12:15 p.m. – 1:30 p.m.
    Lunch

    1:30 p.m. – 3:00 p.m.
    P3: The Future of Visual Inspection
    Moderator: Rob Miller,
    Senior Manager, Technical Services, Pfizer, Inc.

    Session Description: This session will review technologies that have affected the visual inspection process and new technologies that may have an impact in the future. The validation of these technologies along with how regulations may impact their adoption will also be explored. Topics that will be discussed include:

    • Established and emerging tech
    • Particle/leak detection
    • Visual Inspection’s role in the control and monitoring of components and processes
    • Regulation and policy requirements

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

    3:45 p.m. – 5:15 p.m.
    P4: Panel Discussion

    Session Description: 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

    Panelists

    John G. Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting, LLC. and Visual Inspection Interest Group Leader
    Rob Miller, Senior Manager, Technical Services, Pfizer, Inc.
    Rick Watson, Director, Sterile & Validation COE, Merck and Co., Inc.

Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    More information coming soon.

  • Accreditation

    Accreditation

    Continuing Education for Pharmacists

    ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:


    Type of Activity:

    ALERT   ACPE and NABP developed the CPE Monitor that allows pharmacists to electronically track their continuing pharmacy education (CPE) credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE-accredited activity. Always submit CPE activity claims as soon as possible. For more information, please visit the ACPE or NABP website.

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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.

  • Accommodations
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Registration Fees

Early Registration
Regular Registration

* 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 registration@pda.org or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent by , no fee will be charged. After , 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 , a full refund will be given minus a $200 fee. After , no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to registration@pda.org. Phone messages are not accepted.

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Exhibition Inquiries
Training Course Inquiries
Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
registration@pda.org

 

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