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2018 PDA Glass Quality Conference

Jan 23 - Jan 24, 2018
Washington, DC

Improving Primary Packaging of Parenterals

  • Conference
  • The Americas
Program Highlights

Take advantage of this opportunity to explore the many developments and improvements in pharmaceutical glass quality. Through interactive plenary and breakout sessions, discuss current challenges with glass packaging and brainstorm possible improvements to pursue in glass manufacturing, characterization, handling, and packaging.

Save the Date for the 2018 PDA Universe of Pre-filled Syringes and Injection Devices, Oct. 8-9 in Orlando, FL!

Overview

Since a spike in recalls and warning letters related to glass packaging occurred early this decade, there have been many developments and improvements in glass quality, including new formulations and processes for pharmaceutical packaging. This conference will explore the important research being conducted and the advancements offered to industry. Included are presentations on better analytical test methods, improved process controls, glass handling practices, and inspection techniques. We will delve into the improved glasses and new formulations, glass strengthening techniques and special coatings that are being developed and offered. The conference will explore the issues of glass-drug interactions; glass breakage and glass particulate. The challenges of regulatory acceptance of innovation will be addressed along with revising and modernizing pharmacopeias.

Presenters will be subject matter experts from glass manufacturers; with views and case studies given by pharmaceutical and biopharmaceutical company representatives; along with perspectives of the regulators.

The 2018 PDA Glass Quality Conference is back after nearly five years. It is an opportunity to review where we are, and explore many of the developments that have occurred during the last few years and look to our future in the field of pharmaceutical glass packaging. 

Additionally, the Conference will include an exhibition of glass, packaging, testing facilities, glass inspection, and equipment companies over the dates of the Conference.

Who Should Attend

Persons involved in selection and quality assurance of glass packaging; manufacturing of products packaged in glass, glass suppliers, and regulators.

Specifically, pharmaceutical and biopharmaceutical professionals with the following responsibilities are encouraged to participate: Quality Assurance | Packaging | Supplier Control | Glass Suppliers | FDA Regulators | Product Development

Contact

Brooke Schneider, CMP
Manager, Programs
Tel: (301) 656-5900 ext. 111
Email: [email protected]

Registration Customer Care
Tel: +1 (301) 656-5900 ext. 115
Email: [email protected]

Exhibition Inquiries
David Hall
Vice President, Sales 
Tel: +1 (240) 688- 4405
Email: [email protected]

Agenda

  • Tuesday, January 23

    7:15 a.m. – 5:45 p.m.
    Registration Open

    7:15 a.m. – 8:15 a.m.
    Continental Breakfast

    8:15 a.m. – 8:30 a.m.
    Welcome and Opening Remarks from Conference Chair 
    Roger Asselta
    , Vice President, Technical Services, Genesis Packaging Technologies, A Division of R-V Industries, Inc.

    8:30 a.m. – 10:15 a.m.
    P1: Regulatory Perspectives and Updates
    Moderator: Roger Asselta
    , Vice President, Technical Services, Genesis Packaging Technologies, A Division of R-V Industries, Inc.

    Session Description: This Opening Plenary will provide a regulator’s perspective on pharmaceutical glass packaging in the years since the U.S. FDA issued its advisory to the industry, including trends in recalls and warnings and some insight into current developments. Updates will be presented on reviews and revisions to USP chapters covering pharmaceutical glass.

    8:30 a.m. – 8:55 a.m.
    Compliance Perspective on Glass and Injectable Drug Quality        
    David J. Jaworski, MBA, Senior Policy Advisor, CDER, FDA

    8:55 a.m. – 9:20 a.m.
    Compendial Effort to Revise USP <660> <1660> Glass-Containers
    Carol Rea Flynn, MS, Glass Standards and Technical Services Manager, Corning Pharmaceutical Technologies 

    9:20 a.m. – 9:45 a.m.
    ICG TC12 "Pharma Packaging": Pharmacopeial Procedures for Proper Autoclave Cycles
    Daniele Zuccato, Core Team Leader, Nuova Ompi

    9:45 a.m. – 10:15a.m.       
    Questions and Answers/Discussion

    10:00 a.m. – 7:30 p.m. 
    Exhibit Area Open

    10:15 a.m. – 11:00 a.m.
    Refreshment Break in Exhibit Area

    11:00 a.m. – 12:30 p.m.
    P2: Glass Material Developments, Part 1
    Moderator: Xu Song, MS,
    Principal Engineer, Manufacturing Science and Technology (Biologics), Bristol-Myers Squibb

    Session Description: This session will address the recent developments and innovations in the glass material for pharmaceutical parenteral packaging. The session will have presentations on the new aluminosilicate glass and quartz that offers unique benefits over the borosilicate glass followed by case studies.

    11:00 a.m. – 11:30 a.m.
    Design and Performance of an Aluminosilicate Glass for Packaging Parenterals
    Robert Schaut, PhD, Research Associate, Corning Incorporated

    11:30 a.m. – 12:00 p.m.
    Fused Quartz Vials for Enhanced Chemical Stability
    Ben Gauthier, Global Platform Development Leader, Momentive Performance Materials

    12:00 p.m. – 12:30p.m.
    Questions and Answers/Discussion

    12:30 p.m. – 2:00 p.m.
    Lunch on Your Own. Exhibit Area Closed. A listing of local restaurants is available at the PDA registration desk.

    2:00 p.m. – 3:30 p.m.
    P3: Glass Material Developments, Part 2
    Moderator: Xu Song, MS,
    Principal Engineer, Manufacturing Science and Technology (Biologics), Bristol-Myers Squibb

    Session Description: Continuing the discussion from the previous Plenary, presentations in this session will focus on the latest improvements to borosilicate glass containers. The latest developments in glass surface treatment and coating, leading to improved compatibility with drug product, will be discussed and presentations will illustrate the efforts and progress made in overall glass container quality.

    2:00 p.m. – 2:30 p.m.
    Novel Approach Beyond Process Control to Address Interactions in Tubular Glass Vials
    David Lisman, MBA, Strategic Project Manager, Nipro PharmaPackaging

    2:30 p.m. – 3:00 p.m.
    A Breakthrough Treatment Technology for High-Demanding Drugs
    Riccardo Gallo, Manager, Customer Quality Management, Ompi

    3:00 p.m. – 3:30 p.m.
    Questions and Answers/Discussion

    3:30 p.m. – 4:15 p.m.
    Refreshment Break in Exhibit Area

    4:15 p.m. – 5:45 p.m.
    P4: Challenges in Adoption of New Primary Packaging Materials
    Moderator: Roger Asselta,
    Vice President, Technical Services, Genesis Packaging Technologies, A Division of R-V Industries, Inc.

    Session Description: This session offers insight into the many challenges that the Pharmaceutical industry will face with the implementation of new packaging materials. Find out how these new materials are expected to address the regulatory expectations regarding such issues as the interaction of high PH drug products and new biologics with the containers. We will also discuss how these new packaging materials will maintain the protection and purity of the product while assuring the increased scrutiny of quality surrounding the concerns of particulates and delamination.

    4:15 p.m. – 4:45 p.m.
    CDER Approaches for Facilitating the Development and Implementation 
    Sau "Larry" Lee, PhD, Deputy Director, Office of Testing and Research, CDER, FDA

    4:45 p.m. – 5:15 p.m.
    New Vial Technologies for Pharmaceutical Products
    Dawn Watson, Director - Sterile Technology & Commercialization, Merck & Co./Merck Sharp & Dohme

    5:15 p.m. – 5:45 p.m.
    Questions and Answers/Discussion

    5:45 p.m. – 7:00 p.m.
    Networking Reception in Exhibit Area

    Wednesday, January 24

    7:30 a.m. – 5:00 p.m.
    Registration Open

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

    8:30 a.m. – 10:00 a.m.
    P5: Why Good Glass Handling Practices Matter and Ways to Improve your Company’s Practices
    Moderator: David R. Gatzke,
    Technical Advisor, Modality Solutions

    Session Description: The “strength” of glass may be directly related to the amount and severity of surface flaws and every link in the pharmaceutical container supply chain provides an opportunity to either protect or damage the glass. Therefore, an awareness of the importance for good glass handling practices is critical to ensure quality and patient safety. This session will explore recent developments and innovation in glass handling for pharmaceutical parenteral containers with a presentation from an equipment manufacturer on developments that have improved glass handling followed by case studies from the pharmaceutical industry.

    8:30 a.m. – 9:00 a.m.
    Processing of Glass Containers – a Machine Manufacturers Perspective
    Klaus Ullherr, Product Management Pharma Liquid, Robert Bosch Packaging Technology GmbH

    9:00 a.m. – 9:30 a.m.
    Reduction of Glass Breakage in Pharmaceutical Process, a Systematic and Practical Approach
    Mads Reedtz Espersen, Principal Specialist, Primary Packaging Development, Novo Nordisk A/S

    9:30 a.m. – 10:00 a.m.
    Questions and Answers/ Discussion

    9:45 a.m. – 4:00 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.
    P6: Key Issues with Glass Containers
    Moderator:
    James T. McFarland, Senior Regulatory Manager, Gerresheimer

    Session Description: The glass we use to transport, store, protect, and deliver injectable medicines has remained standard over the past 50 years. Technological advances including faster filling lines, highly aggressive drug formulations, more sophisticated drug delivery systems, and increased regulatory expectations have created greater demands on the glass container. As a result, the need for different glass vial technologies has grown. This session will take a new glass technology and walk you through the qualification process from suitability considerations, including compatibility, as well as operational considerations of various improved glass technologies.

    10:45 a.m. – 11:15 a.m.
    Understanding Glass Breakage Through Fractography - A Key to Reliability
    Jim R. Varner, Professor of Ceramic Engineering, Emeritus, Alfred University

    11:15 a.m. – 11:45 a.m.
    Advances in Performance and Testing of Type I Borosilicate Glasses
    Daniel Haines, PhD, Scientific Advisor, Pharma Services, SCHOTT Pharmaceutical Packaging

    11:45 a.m. – 12:15 p.m.
    Questions and Answers/ Discussion

    12:15 p.m. – 1:45 p.m.
    Lunch on Your Own. Exhibit Area Closed. A listing of local restaurants is available at the PDA registration desk.

    1:45 p.m. – 3:15 p.m.
    P7: PDA Updates – Connecting People, Science, and Regulation
    Moderator:
    Carol Rea Flynn, Glass Standards and Technical Services Manager, Corning Pharmaceutical Technologies

    Session Description: PDA connects you to more technical resources than any other organization, helping you find solutions to challenges you face every day. PDA provides technical reports, peer-reviewed scientific research, training, conferences, interest groups, and more. First, PDA will present the results of the recent Glass Quality Survey, including such topics as glass container quality, recall rates, cost of defect recalls, critical glass vial defect complaint rate, out-of-spec for glass related defects, re-inspection practices, and more. Second, pharmaceutical companies, glass suppliers, and machine manufacturers have joined together to form a Glass Handling Task Force. A Glass Handling Task Force member will provide insight on the Task Force’s progress to date and future objectives.

    1:45 p.m. – 2:15 a.m.
    PDA Glass Quality Survey Results
    Richard M. Johnson, President & CEO, PDA

    2:15 p.m. – 2:45 p.m.
    PDA Glass Handling Task Force Updates
    James T. McFarland, Senior Regulatory Manager, Gerresheimer

    2:45 p.m. - 3:15 p.m.
    Questions and Answers/ Discussion

    3:15 p.m. – 4:00 p.m.
    Refreshment Break in Exhibit Area

    4:00 p.m. – 4:45 p.m.
    P8: Panel Discussion
    Moderator:
    Richard M. Johnson, President & CEO, PDA

    Session Description: Our final session will include a discussion by a panel of experts from the glass and pharmaceutical industries as well as regulators, moderated by PDA’s President & CEO, Richard Johnson. Our expert panel will recap the conference proceedings and provide their perspectives on these developments and the potential impact in parenteral packaging. The session will conclude with an open forum for further questions and comments by the all participants in the conference.

    Mads Reedtz Espersen, Principal Specialist, Primary Packaging Development, Novo Nordisk A/S 
    David J. Jaworski, MBA, Senior Policy Advisor, CDER, FDA
    Xu Song, MS, Principal Engineer, Manufacturing Science and Technology (Biologics), Bristol-Myers Squibb
    Dawn Watson, Director - Sterile Technology & Commercialization, Merck & Co./Merck Sharp & Dohme

    4:45 p.m. – 5:00 p.m
    Closing Remarks and Adjournment from Conference Chair
    Roger Asselta, Vice President, Technical Services, Genesis Packaging Technologies | A Division of R-V Industries, 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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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 [email protected] 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 [email protected]. Phone messages are not accepted.

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Tel: +1 (301) 656-5900 ext. 115
[email protected]

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