pda.org/2018Glass
2018 PDA Glass Quality Conference
o Si
Improving Primary Packaging of Parenterals
Oxygen
Na
Calcium
Sodium
K
Silicon
Ca Si
Al
Potassium
Silicon
o
Aluminum
K
Potassium
K
Potassium
B
Boron
Al
Aluminum
B
Boron January 23-24, 2018 | Washington, DC Exhibition: January 23-24 #PDAGLASS This preliminary schedule-at-a-glance is current as of December 13, 2017 RECORDINGS ARE PROHIBITED AT ALL PDA EVENTS
Oxygen
Na Sodium
CONNECTING
PEOPLE+ SCIENCE
REGULATION
®
2018 PDA GLASS QUALITY CONFERENCE – GENERAL INFORMATION
Connecting People, Science and RegulationÂŽ
PROGRAM PLANNING COMMITTEE
A MESSAGE FROM THE PROGRAM CHAIR Dear Friends and Colleagues,
Program Chair:
On behalf of the Program Planning Committee, I would like to invite you to attend the 2018 PDA Glass Quality Conference.
Roger Asselta Genesis Packaging Technologies, A Division of R-V Industries, Inc.
Carol Rea Flynn, MS Corning Pharmaceutical Technologies David R. Gatzke, MBA Eli Lilly and Company Jennifer Johns Pfizer Inc. James T. McFarland Gerresheimer Xu Song, MS Bristol-Myers Squibb Jahanvi (Janie) Miller, MBA PDA Brooke Schneider, CMP PDA
Roger Asselta Genesis Packaging Technologies, A Division of R-V Industries, Inc.
We all remember the significant spike in the number of drug recalls related to glass packaging that occurred earlier this decade. There were concerns that the problems associated with glass quality were contributing to certain drug shortages. The U.S. FDA took the unusual step of issuing an advisory to drug manufacturers on the Formation of Glass Lamellae in Certain Injectable Drugs in March of 2011.
In response, PDA and the U.S. FDA co-sponsored the first Glass Quality Conference in Washington, DC later that year. The program focused on understanding the causes of breaches in glass quality and brainstorming possible solutions. It was very well attended by stakeholders at every level and in all areas of parenteral packaging, including glass suppliers and pharmaceutical users, scientists and regulators, and professionals in package development, quality, pharmaceutical manufacturing, and testing. In the next two years, additional PDA conferences shifted the focus from the issues to exploring potential solutions and controls to ensure fitness for use, patient safety, and glass compatibility to the drug product. Since our last Conference on Glass Quality five years ago, our work has continued. Important research has been completed and published; reliable analytical test methods have been developed; and new process controls, glass handling practices, and inspection techniques have been implemented. Improved glasses are constantly being developed, and pharmacopeias have been revised to make them more relevant to these concerns and new glass options. At our 2018 Conference, we will use an evaluation of the past to help inform us about future innovation. Join us as we explore many of the developments that have occurred over the last few years and look to the future in the field of pharmaceutical glass packaging. Expert glass manufacturers will share the latest on improved process controls, glass handling practices, and inspection techniques. Through presentations and case studies, topics such as glass-drug interactions, glass breakage, and glass particulate will be discussed. Regulators will present their perspectives on new advances in glass quality. Take advantage of plenty of opportunities to discuss current glass packaging challenges and brainstorm possible improvements to glass manufacturing, characterization, handling, and packaging. Be sure to visit the Exhibit Area to see the latest from glass, packaging, testing glass inspection, and equipment vendors. Network with friends and colleagues, old and new, at the Networking Reception, and other opportunities to connect and share. We look forward to seeing you in Washington, DC on January 23-24, 2018 for the PDA Glass Quality Conference!
2
January 23-24, 2018 | Washington, DC
Exhibition: January 23-24 #PDAGLASS
GENERAL INFORMATION REGISTER NOW
Online: pda.org/2018Glass Fax: +1 (301) 986-1093 (USA) Questions? Call registration at +1 (301) 656-5900 ext. 115
VENUE
Omni Shoreham Hotel 2500 Calvert Street, NW Washington, DC 20008 Phone: +1 (202) 234-0700 Website: www.omnihotels.com/hotels/washington-dc-shoreham Rate: Single/Double: $179, plus applicable state and local taxes Cut-off Date: Tuesday, December 26, 2017 (Rooms must be secured by this date in order to receive the PDA rate.) Rates are guaranteed until the PDA block of rooms are sold out on a first-come basis.
CONTINUING EDUCATION CREDITS 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 email the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive CPE credit. ALERT: ACPE and the National Association of Boards of Pharmacy developed the Continuing Pharmacy Education (CPE) Monitor that allows pharmacists to electronically track their 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 and by the deadline specified on the CPE credit request form. 2018 PDA Glass Quality Conference ACPE # 0116-0000-17-036-L04-P | 1.15 CEUs Type of Activity: Knowledge
LEARNING OBJECTIVES At the completion of this Conference, participants will be able to: • Discuss current issues with glass packaging • Identify best practices on glass handling • Summarize current expectations for incoming glass and pharmaceutical product packaging • Describe effective glass supplier relationship for product improvement
• Find new analytical techniques that are being used to analyze bioproduct interactions with solid surfaces • Summarize the historical basis for the interaction of biomolecules with packaging surfaces • Identify technologies that are available for glass strengthening • Describe how the manufacturing environment can create glass defects that lead to eventual breakage • Examine possible improvements in glass manufacturing, characterization, handling, or packaging to be pursued • Review recent developments in glass packaging
WHO SHOULD ATTEND
Job Function: Persons involved in selection and quality assurance of glass packaging or manufacturing of products packaged in glass, glass suppliers, and regulators. Departments: Quality Assurance | Packaging | Supplier Control | Glass Suppliers | Regulators | Product Development
CONFERENCE REGISTRATION HOURS
Tuesday, January 23: 7:15 a.m. – 4:30 p.m. Wednesday, January 24: 7:30 a.m. – 4:15 p.m.
DRESS/ATTIRE Business casual attire is recommended for the 2018 PDA Glass Quality Conference. Since the temperature in meeting rooms tends to be cool, please bring a jacket or sweater for your comfort.
SPECIAL REQUIREMENTS If you require special accommodations to fully participate, please attach a written description of your needs with your registration form. Specific questions can be directed to registration@pda.org.
CONTACT INFORMATION Conference Inquiries Brooke Schneider, CMP, Manager, Programs Tel: +1 (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 Alison Caballero, Senior Sales Coordinator Tel: +1 (301) 656-5900 ext. 135 | Email: caballero@pda.org
3
2018 PDA GLASS QUALITY CONFERENCE – GENERAL INFORMATION
2018 PDA Glass Quality Conference
2018 PDA GLASS QUALITY CONFERENCE – SCHEDULE-AT-A-GLANCE
Connecting People, Science and Regulation®
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. – 10:00 a.m. P1: Welcome and Opening Remarks from Conference Chair and Opening Plenary Session 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. 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 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. 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 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. 3:30 p.m. – 4:15 p.m. Refreshment Break in Exhibit Area
4
January 23-24, 2018 | Washington, DC
TUESDAY, JANUARY 23 – WEDNESDAY, JANUARY 24
Exhibition: January 23-24 #PDAGLASS
4:15 p.m. – 6:15 p.m. P4: Challenges in Adoption of New Primary Packaging Materials 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. 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 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. 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: Evaluating Key Issues with Glass Containers 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 walk you through the qualification process from suitability considerations, including compatibility, as well as operational considerations of various improved glass technologies. 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.
5
2018 PDA GLASS QUALITY CONFERENCE – SCHEDULE-AT-A-GLANCE
2018 PDA Glass Quality Conference
2018 PDA GLASS QUALITY CONFERENCE – SCHEDULE-AT-A-GLANCE
Connecting People, Science and Regulation®
WEDNESDAY, JANUARY 24 (CONTINUED) 1:45 p.m. – 3:15 p.m. P7: PDA Updates – Connecting People, Science, and Regulation 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. 3:15 p.m. – 4:00 p.m. Refreshment Break in Exhibit Area 4:00 p.m. – 5:00 p.m. P8: Panel Discussion, Thank You, and Closing Remarks from Conference Chair 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.
Sponsorship and Exhibit Opportunities Available! The 2018 PDA Glass Quality Conference is a unique opportunity to attract an audience of “movers and shakers” in the field of pharmaceutical glass packaging. Get your product or service in front of these influential decision makers by exhibiting at or sponsoring the 2018 PDA Glass Quality Conference! Sponsor a Refreshment Break, Luncheon, or Networking Reception for maximum visibility to attendees. Opportunities for expanding brand recognition include sponsoring tote bags, lanyards, and wireless Internet service. Or, customize your promotional package to fit your company’s specific needs. For exhibit and/or sponsorship information, please contact: David Hall, Vice President, Sales Phone: +1 (240) 688-4405 | Email: hall@pda.org
6
2018 PDA Glass Quality Conference January 23-24, 2018 | Washington, DC Omni Shoreham Hotel Exhibition: January 23-24
1 Contact Information Prefix
REGISTER NOW Online: pda.org/2018Glass Fax: +1 (301) 986-1093 (USA) Questions? Call registration at +1 (301) 656-5900 ext. 115
PDA Membership Number
First Name
Job Title
Last Name
Company
Business Address City State/Province Zip Code Country Email Business Phone Fax Substituting for (Check only if you are substituting for a previously enrolled colleague. The fee difference in the prevailing rate is due at the time of substitution. Please note that if you are a non-member substituting for a member, you will be required to pay the difference in the non-member fee.)
Check here to become a member and receive the member price for this event. (Add $279 to your total.)
3 ONE DAY ONLY Registration Please check appropriate fee (US$).*
2 CONFERENCE Registration | January 23-24 Please check appropriate fee (US$). By Nov. 13, 2017
After Nov. 13, 2017
PDA Member
$ 1,895
$ 2,095
Non-member
$ 2,174
$ 2,374
Young Professional Member
$ 948
$ 1,048
Government/ Health Authority
Member Non-member*
$ 700 $ 800
$ 700 $ 800
Academic
Member Non-member*
$ 700 $ 800
$ 700 $ 800
Student
Member Non-member*
$ 280 $ 310
$ 280 $ 310
Tuesday, Jan. 23
Wednesday, Jan. 24
PDA Member
$ 1,248
$ 1,248
Non-member
$ 1,387
$ 1,387
* This rate is currently not available online.
Special Dietary Requirements (Please be specific):
Please note: In order to receive the prevailing rate, your registration(s) with payment must be received by PDA by 5:00 p.m. ET on or before the date noted.
* For this member type or discounted rate, online registration is not available and must be faxed in.
Payment Options All cards are charged in US$. Group Registration: Register 3 people from the same organization as a group (at the same time) for the CONFERENCE and receive the 4th registration free. 4 Other discounts cannot be applied. All forms MUST be faxed in together. By Credit Card – Clearly indicate account number, expiration date, and billing address. Please bill my: American Express MasterCard VISA Credit Card Guarantee Only
Total amount $
Account Number Exp. Date Name (exactly as it appears on card) Signature Billing Address (must match credit card statement) PDA Federal Tax I.D. #52-1906152 City State Zip Code
Country
Wire Transfer Payments: If you require wire transfer, please contact registration@pda.org.
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 in the non-member fee. If you are pre-registering as a subsitute 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 Conference/Event: If your written request is 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 THAT YOUR PHOTO ID WILL BE REQUIRED IN ORDER TO PICK UP BADGE MATERIALS ONSITE. THIS IMPORTANT SECURITY PROCEDURE WILL PREVENT ANYONE OTHER THAN THE REGISTRANT FROM PICKING UP THEIR BADGES 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. PDA USE ONLY Date:
Check:
Amount:
Account: