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Parenteral Drug Association Connecting People, Science and Regulation ®

2018 PDA Glass Quality Conference

Improving Primary Packaging of Parenterals
Jan 23 - Jan 24, 2018 |
Jan 24, 2018 |
Omni Shoreham Hotel | Washington, DC
  • Conference
  • Western Hemisphere Events
Exhibition: January 23-24
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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: schneider@pda.org

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

Tuesday, January 23

7:15 a.m. – 4:30 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. – 10:00 a.m.
P1: Opening Plenary Session
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. – 9:00 a.m.
Update on U.S. FDA Advisory and Update on 1999 CCS Guidance rewrite        
David J. Jaworski, MBA, Senior Policy Advisor, CDER, FDA

9:00 a.m. – 9:30 a.m.
Update and USP Glass chapters <660>, <1660>
USP Glass Expert Panel Member

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

9:45 a.m. – 7:30 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: 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 a presentation on the new aluminosilicate glass that offers unique benefits over the borosilicate glass followed by case studies.

10:45 a.m. – 11:15 a.m.
Design and Performance of an Aluminosilicate Glass for Packaging Parenterals
Robert Schaut, PhD, Research Associate, Corning Incorporated

11:15 a.m. – 11:45 a.m.
A Breakthrough Coating Technology for High-Demanding Drugs
Riccardo Gallo, Manager, Customer Quality Management, Ompi

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. – 3:30 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.

1:45 p.m. – 2:10 p.m.
Novel Approach Beyond Process Control to Address Interactions in Tubular Glass Vials
David Lisman, MBA, Strategic Projects Manager, Nipro PharmaPackaging

2:10 p.m. – 2:35 p.m.
Industry perspectives on Glass Material Developments
Industry Representative Invited

2:35 p.m. – 3:00 p.m.
Fused Quartz Vials for Enhanced Chemical Stability
Ben Gauthier, Global Platform Development Leader, Momentive Performance Materials

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

3:30 p.m. – 4:45 p.m.
Refreshment Break in Exhibit Area

4:15 p.m. – 6:15 p.m.
P4: Challenges in Adoption of New Primary Packaging Materials
Moderator: Jennifer Johns,
Director, Packaging and Device Services, Pfizer 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.
Regulatory Pathway for Filing for New Materials Regulatory Expectations on New Technologies
Regulatory Representative Invited

4:45 p.m. – 5:15 p.m.
Case Study: Introduction of Valor™ Vial for Pharmaceutical Products
Dawn Watson, Director - Sterile Technology & Commercialization, Merck & Co./Merck Sharp & Dohme

5:15 p.m. – 5:45 p.m.
Operational Technical Considerations Associated with Qualification of New Glass Vial Technology
Heriberto Delgado, Principal Engineer, Pfizer Inc.

5:45 p.m. – 6:15 p.m.
Questions and Answers/Discussion

6:15 p.m. – 7:30 p.m.
Networking Reception in Exhibit Area

Wednesday, January 24

7:30 a.m. – 4:15 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,
Research Scientist, Technical Services/Manufacturing Science, Eli Lilly and Company

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
James 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.

Heriberto Delgado, Principal Engineer, Pfizer Inc.
David J. Jaworski, MBA, Senior Policy Advisor, CDER, FDA
Dawn Watson, Director - Sterile Technology & Commercialization, Merck & Co./Merck Sharp & Dohme
Regulatory Representative Invited

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.

Conference Registration | January 23-24

Member

By November 13, 2017
$1,895

After November 13, 2017
$2,095

Non-member

By November 13, 2017
$2,174

After November 13, 2017
$2,374


Government/Health Authority

Member

By November 13, 2017
$700

After November 13, 2017
$700

Non-member*

By November 13, 2017
$800

After November 13, 2017
$800


Academic

Member

By November 13, 2017
$700

After November 13, 2017
$700

Non-member*

By November 13, 2017
$800

After November 13, 2017
$800


Student

Member

By November 13, 2017
$280

After November 13, 2017
$280

Non-member*

By November 13, 2017
$310

After November 13, 2017
$310


Young Professional Member †

Member

By November 13, 2017
$948

After November 13, 2017
$1,048


One Day Only Fee

Tuesday/Wednesday Only

PDA Member
$1,248

Nonmember
$1,387

All prices in US dollars.

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

† You must be a member to take advantage of this rate.

Please note: In order to receive the prevailing registration rate, your registration(s) must be received by PDA by 5:00 p.m. ET on or before the date noted.

Please read PDA's confirmation, substitution, refund, and photo release policies for this workshop and course.

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

Please let us know if you have any special dietary requirement we may assist you with. Please contact us at registration@pda.org for help.

CONFIRMATION: A letter of confirmation will be sent to you once payment is received. You must have this written confirmation to be considered enrolled in a PDA event. Please allow one week for receipt of confirmation letter. If you have submitted a purchase order or requested an invoice please be advised that a credit card guarantee is needed. Please be advised that if your payment or written cancelation notice is not received by November 24, 2017 your credit card will be charged the prevailing rate.

SUBSTITUTIONS: If you are unable to attend, substitutions can be made at any time, including onsite for a fee of $200. If you are a non-member substituting for a member, you will be required to pay the difference non-member fee. If you are pre-registering as a substitute attendee, indicate this on the registration form.

REFUNDS: Refund requests must be in writing and faxed to +1 (301) 986-1093. (Emails and phone messages are not accepted). Refunds for Full Conference, Workshops and Events: If your written request in received on or before November 24, 2017, you will receive a full refund minus a $200 processing fee. After that time, no refunds or credit requests will be approved. Onsite registrants are not guaranteed to receive Conference materials until all advanced registered attendees receive them. PDA reserves the right to modify the material or speakers/instructors without notice or to cancel an event. If an event must be canceled, registrants will be notified by PDA in writing as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancelation. For more details, contact PDA at info@pda.org or +1 (301) 656-5900.

PLEASE NOTE: Photo ID will be required in order to pick up badge materials on-site. This important security procedure will prevent anyone other than the registrant from picking up their badge and materials.

RECORDING/PHOTO RELEASE: By registering for these events, I authorize PDA to record and photograph me and to use the recordings/photographs in all formats and media for any purpose, including for education, marketing and trade purposes. I hereby release PDA from all claims arising out of the use of the recordings/photographs, including without limitation all claims for compensation, libel, invasion of privacy or violation of copyright ownership. Tape recordings are prohibited at all PDA Conferences.

Omni Shoreham Hotel

Omni Shoreham Hotel
2500 Calvert Street NW
Washington, DC 20008
Phone: +1 (202) 234-0700

Rate: Single: $179.00, plus applicable taxes (14.5%).

Cut Off Date: Tuesday, December 26, 2017 (Availability may be limited. Requests will be processed on a first-come, first-served basis. Attendees staying within the PDA block will receive the conference rate.)

Hotel Accommodations

To make reservations at the Omni Shoreham Hotel, please call the Hotel at +1 (202) 234-0700 and reference the PDA event to receive the PDA group rate. Check in time is 3:00 p.m., and check out time is 12:00 noon.

Individual Cancellation

Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. Individuals will be responsible for payment of their own cancellation fees. The cancellation policy is by 12 p.m. three days prior to the date of arrival otherwise specified on your reservation information.

Amenities

Since 1930, the luxurious Omni Shoreham Hotel in Washington, D.C. has played host to presidents, world leaders and inaugural balls, making it a true Washington landmark. The 834 luxury guest rooms are located steps away from the National Zoo. For a full list of hotel amenities - click here.

Travel

Area Airports
Ronald Reagan Washington National (DCA) is approximately 8 miles away. Two other airports in the vicinity are both serviced by all major carriers: Dulles International (IAD) is 28 miles away and Baltimore/Washington (BWI) is 34 miles away.

Ground Transportation
Taxi fares from Reagan National are $20-$25 one way, not including tip, and will take about 20 minutes. One way taxi fares from Dulles is $50-$65 and from BWI is about $75-$100.

Metro
Woodley Park Metro Station is 0.2 miles away from the hotel and is approximately $2.35-$3.25 one way to Reagan National.

Train
Union Station is 4 miles away from the hotel. To book your reservation call Amtrak at 1 (800) 872-7245 or visit http://www.amtrak.com.

Driving
Visit this page for detailed driving directions to the Omni Shoreham Hotel.

Hotel Parking
$49 / Valet parking only - per car, per day

The PDA Glass Quality Conference will provide your company exclusive exhibit and sponsorship opportunities to gain access to and network with key decision makers from the biopharmaceutical industry involved in the development and improvement of glass quality. Attendees will include industry professionals from manufacturing, packaging, quality assurance, and product development.

With multiple networking breaks, luncheon, and reception, you have ample time to connect with your desired audience of industry leaders. Comprehensive exhibition packages allow you the opportunity to partake in the conference sessions and gain firsthand insights on what the industry is looking for so you can better position your product and/or service offerings.

Become a sponsor at the conference to strengthen your brand image, increase your visibility, and align your company with industry leading minds and world class content. High profile sponsorships are available for lanyards, notepads, audience response systems, tote bags, refreshment breaks, lunch and networking reception. We’ll create a customized sponsorship to fit your needs and budget.

The tabletop package includes one full conference registration, one exhibit only badge, company listing on the conference website and in the on-site exhibit guide, and access to key decision makers in this dynamic field.

For more information about exhibit and sponsorship opportunities, please contact:

David Hall

+1 (301) 656-5900 ext. 160
Cell +1 (240) 688-4405
hall@pda.org

Alison Caballero

+1 (301) 656-5900 ext. 135
caballero@pda.org

Register Now
https://store.pda.org/Meetings/Login.aspx?ID=3907

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