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Parenteral Drug Association Connecting People, Science and Regulation ®

2018 PDA Sterile Medicinal Products Manufacturing Conference

May 14 - May 15, 2018 |
May 15, 2018 |
Hyatt Regency Bethesda | Bethesda, MD
  • Conference
  • Western Hemisphere Events
Exhibition: May 14-15
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Speaker Biographies

Regulatory expectations, including the use of more effective risk-based decision making, have changed due to the expansion of global manufacturing, the need to produce new therapies and products, and the use of new technologies. As a result, aseptic processing and terminal sterilization practices have been revisited, and the need for more reliable, efficient, and effective product manufacturing, control, and release processes has emerged. The proposed revision to EU Annex 1: Manufacture of Sterile Medicinal Products aims to address these trends.

Over the past decade, Aseptic Processing has increasingly become a prominent method for manufacturing sterile pharmaceutical products. It is the preferred, and in many cases, the only method available for manufacturing many of the new biologic therapies, even as it continues to be the method used for many long-standing more traditional drug products. In addition, there has been renewed interest in the use of terminal sterilization and post-aseptic processing microbiological treatments/sterilization to ensure product quality and sterility.

Health authorities from around the world are tightening expectations for sterile product quality and safety, based on patient risk. Producers of sterile products are contemplating true risk-based approaches to improve manufacturing and manufacturing controls to better meet challenges and comply with regulatory requirements. The need for dialogue and partnership between manufacturers, suppliers, and regulators is growing as a means to solve issues and improve.

The 2018 PDA Sterile Medicinal Products Manufacturing Conference will bring together sterile product experts and the sterile products community to highlight contemporary approaches for sterile product manufacturing. This will be done using case studies and personal experiences from recognized industry and regulatory agency experts. The Conference will cover modern approaches to aseptic product manufacturing and will focus on the following sterile product manufacturing essentials, with special reference to the draft revision of the EU GMP Annex 1:

  • Risk- and science-based assessment and approaches in sterile product facility design and manufacturing processes – what works and what may not be worth the risk
  • Modern methods for cleanroom qualification, environmental monitoring, and contamination control
  • How to better use existing sterile product technologies
  • PDA and industry responses to the proposed revision to Annex 1 and other regulatory trends and expectations
  • New thinking on sterile product manufacturing validation and process simulation

Learning Objectives

At the completion of this Conference, the participant will be prepared to better understand and meet the challenges of manufacturing healthcare sterile products in a modern global technological and regulatory environment by:

  • Explaining the latest methods for sterile product manufacturing risk evaluation
  • Describing the benefits associated with post-aseptic processing microbiological treatments/sterilization
  • Interpreting regulatory risk perspectives and implications for sterile product manufacturing and processing
  • Identifying contemporary aseptic processing technologies for risk minimization
  • Recognizing the new requirements present in the draft revised Annex 1

Who Should Attend

Department
Manufacturing | Formulation | Compliance | Engineering | QA/QC | Development | Regulatory Affairs | Research and Development | Technical Operations | Validation

Level of Expertise
Senior Management | Senior Scientists | Project/Program Leader | Technical Contributor

Job Function
Microbiology | Validation | Engineering | Quality | Regulatory | Sterility Assurance | Sterile Operations | Product and Process Development

Conference Inquiries

Brooke Schneider, CMP
Manager, Programs
Tel: +1 (301) 656-5900 ext. 111
Email: schneider@pda.org

Registration Inquiries

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

Exhibition/Sponsorship Inquiries

David Hall
Vice President, Sales
Tel: +1 (301) 656-5900 ext. 160
Email: hall@pda.org

Monday, May 14

7:00 a.m. – 5:30 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 Co-Chair 
Gabriele Gori, 
Vice President, Audit and Risk Management, Global Quality, GSK Vaccines

8:30 a.m. – 10:00 a.m.
P1: Opening Plenary: The State of Sterile Product Manufacturing: Challenges and Opportunities for Improvement 
Moderator: Gabriele Gori, 
Vice President, Audit and Risk Management, Global Quality, GSK Vaccines

Session Description: The conference takes the opportunity of the on-going changes in the European regulations for sterile medicinal product manufacturing to discuss how to move forward to true risk-based manufacturing and control, in order to enhance process robustness and sterility assurance, thus ensuring supply reliability. The necessity for moving forward is illustrated by changes of the scenario where we operate, such as the availability of modern technologies, the development of innovative personalized and alternative therapies, the globalization of the manufacturing and supply chain as well as by increased regulatory expectations. What needs to change is our understanding of the limitations of traditional methods for process and contamination control, our hesitancy to use new technologies, and our awareness of the need to develop manufacturing methods to meet new therapies. This session will present a general overview on positions from industry and health authority on the above topics and will solicit an active dialogue with the participants that will continue through the subsequent conference tracks.

8:30 a.m. – 8:55 a.m.
An Industry Perspective on the Challenges of Modern Sterile Product Manufacturing and the Opportunities for Change
James Klein, PhD, Associate Vice President, Global Technical Operations S&V COE, Sterile Manufacturing Technical Operations, Merck & Co., Inc.

8:55 a.m. – 9:20 a.m.
Sterile Product Manufacturing: Are the Regulators Moving Forward
Marla Stevens-Riley, PhD, Master Microbiology Reviewer, Quality Assessment Lead, CDER, OPQ, FDA

9:20 a.m. – 9:45 a.m.
Sterile Medicines: An Inspectors Perspective
Andrew Hopkins, Expert GDMP Inspector, Medicines and Healthcare Products Regulatory Agency

9:45 a.m. – 10:00 a.m.
Question and Answers/Discussion

9:45 a.m. – 6:30 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: Quality Systems: What Works, What can be Improved, What Should Change?
Moderator: Andrew Hopkins, 
Expert GDMP Inspector, Medicines and Healthcare Products Regulatory Agency

Session Description: Whilst there is common agreement that the implementation of Quality Risk Management (QRM) principles is critical for an efficient and effective design and implementation of facilities and processes in a modern pharmaceutical company, there are instances where the implementation of these principles does not always translate into proper practices in the actual manufacturing and control activities that reduce residual risk to patient to an acceptable level. The purpose of this session is to provide clarity on those principles and provide a real case study on their effective implementation, for a better understanding on such a powerful approach and the associated benefits.

10:45 a.m. – 11:15 a.m.
Overall Theory of Quality Risk Management
Ghada Haddad, MBA, Executive Director, Global cGMP & Compliance Auditing Organization, Merck & Co., Inc.

11:15 a.m. – 11:45 a.m.
Case Study on Quality Risk Management
Mitchell B. Garber, Director, Clinical Global Supplies Sterile, GlaxoSmithKline

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. 
P3: Personnel and Air Monitoring: How to Control the Most Important Variables
Moderator: Frederic B. Ayers, 
Consultant Scientist,Eli Lilly and Company

Session Description: This plenary session will focus on one of the most reviewed metrics for evaluating a facilities overall environmental control. Monitoring of the environment is a required activity that must be reviewed at frequencies that are relevant to the processes within the facilities being monitored. Join us as Personnel Qualification and Use of Settle Plates are discussed in depth.

1:45 p.m. – 2:15 p.m.
Personnel Qualification for Aseptic Processing
David Hussong, PhD, Chief Technical Officer, Eagle Analytical Services and Chair of the USP Microbiology Committee

2:15 p.m. – 2:45 p.m.
Viable Air Monitoring for Aseptic Processing: Active Versus Passive Air Options
Marsha Steed (Hardiman), Senior Consultant, ValSource LLC

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. – 5:30 p.m. 
P4: Science- and Risk-Based Decision-Making to Drive Best Practice in Sterile Product Manufacturing
Moderator:
Hal Baseman, Chief Operations Officer, ValSource LLC

Session Description: Once sterility has been achieved for a process or product, maintenance of integrity is paramount in the manufacture of sterile products. With aseptic processing, sterile integrity of the aseptic line and process must be maintained after sterilization-in-place until the manufacturing campaign is completed. For sterile pharmaceutical products, sterile integrity must be maintained throughout the product’s shelf-life. This session will highlight the risk-based considerations around sterile filtration including pre-use post-sterilization integrity testing. Additionally, recommended best demonstrated scientific practice for container closure integrity testing will be summarized based on current content of the ongoing revision of PDA Technical Report No. 27 on Pharmaceutical Packaging.

4:00 p.m. – 4:10 p.m.
Update on the PDA/BPOG PUPSIT Task Force
Hal Baseman, Chief Operations Officer, ValSource LLC

4:10 p.m. – 4:40 p.m.
Application of Risk-Based Approaches for Sterilizing Filtration
Brian Joseph, Senior Scientist, Regulatory and Validation Consultancy, Pall Life Sciences

4:40 p.m. – 5:10 p.m.
Considerations for a Science- and Risk-Based Container Closure Integrity Testing Program
Sangeetha R. Nair, Senior Quality Technical Consultant, Baxter Healthcare Corporation

5:10 p.m. – 5:30 p.m.
Questions and Answers/Discussion

5:30 p.m. – 6:45 p.m.
Networking Reception in Exhibit Area

Tuesday, May 15

7:15 a.m. – 3:45 p.m. 
Registration Open

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

7:15 a.m. – 8:00 a.m. 
Breakfast Session: Annex 1 PDA Commenting Committee Report
Moderator: Hal Baseman, Chief Operations Officer, ValSource LLC

Session Description: PDA assembled a team of sterile manufacturing and quality control experts. Using input from PDA members, documented PDA positions from its Technical Reports, Aseptic Processing Points to Consider (2015, 2016), Journal Articles, and the team’s acquired knowledge, this team reviewed the Annex 1 Revision, and where necessary, offered comments and recommendations on and to the Annex 1 revision. Those comments have been submitted to the European Commission for consideration. This session will review the PDA commenting process, key comments submitted by PDA, the rationale for PDA proposed changes, and answer questions related to draft Annex 1 revision and PDA response.

7:15 a.m. – 8:00 a.m.
Gabriele Gori, Vice President, Audit and Risk Management, Global Quality, GSK Vaccines

  

8:15 a.m. – 9:45 a.m. 
P5: Aseptic Process Monitoring: How can we Align Modern Requirements and Technologies with Traditional Methods and Expectations
Moderator: Frederic B. Ayers, 
Consultant Scientist,Eli Lilly and Company

Session Description: This plenary session will focus on other metrics for evaluating the overall aseptic process control for manufacturing facilities. Aseptic process simulations and airflow visualization are critical activities for process and facility evaluations. Join us for these in-depth conversations on aseptic process simulations and airflow visualizations.

8:15 a.m. – 8:45 a.m.
Recovery of Propionibacterium Acnes from an Aerobic Process and Implication to the Process Simulation Program
Kenneth W. Boone, Associate Director, Sterile & Microbiology Quality Assurance, Merck & Co., Inc.

8:45 a.m. – 9:15 a.m.
Visualization of Airflow Patterns: From Software Simulation to Aseptic Behavior Optimization
Geert Vandenbossche, PhD, Global Head NTO Quality Strategic Initiatives, Novartis

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

9:30 a.m. – 3:45 p.m.
Exhibit Area Open

9:45 a.m. – 10:30 a.m.
Refreshment Break in Exhibit Area

10:30 a.m. – 12:00 p.m. 
P6: Concepts and Misconcepts for Terminal Sterilization with Moist Heat and Rendering Isolators Sterile
Moderator: 
Geert Vandenbossche, PhD, Global Head NTO Quality Strategic Initiatives, Novartis

Session Description: Terminal sterilization of non-porous loads has different requirements and critical process parameters than porous loads. The presentation will highlight the key differences and bring clarity to points that are not addressed in the Annex-1 draft. The pharmaceutical industry has been moving away from conventional Grade A filling lines with B background to Isolator technology in grade D background. As a result, there is a need for line setup and format changes to take place with an open isolator in a grade D environment. A key question today is how to render all critical surfaces sterile, taking into account the following; a. limitation for VHP and other surface decontamination techniques to contact any hidden surfaces and b. the challenges faced to enter large format parts e.g. vibratory bowls and rails. The goal is to design a process that results in the highest possible sterility assurance level.

10:30 a.m. – 11:00 a.m.
Moist Heat Sterilization Misconceptions 
Roy McLean, Senior Manager, Operations Support, R&D Sterility Assurance, Baxter Healthcare Corporation

11:00 a.m. – 11:30 a.m.
Sterility Assurance for Equipment in Isolators: Challenges and Possibilities
Henrietta Vinnerås, Senior Manager Microbiology and Aseptic Technique, Fresenius Kabi

11:30 a.m. – 12:00 p.m.
Questions and Answers/ Discussion

12:00 p.m. – 1:30 p.m.
Lunch on Your Own. Exhibit Area Closed. A listing of local restaurants is available at the PDA registration desk.

1:30 p.m. – 3:00 p.m. 
P7: Aseptic Processing: Where Can We Go From Here?
Moderator:
Gabriele Gori, Vice President, Audit and Risk Management, Global Quality, GSK Vaccines

Session Description: Increased knowledge on aseptic manufacturing and improved process design can open the door to enhanced control strategies which are more efficient and effective than the ones implemented today. The introduction of new therapies are changing risk profiles, typical contributors of contamination, and forcing the industry to look for innovative approaches for process control and product release. This session will explore real time release for aseptic processing and other regulatory and process challenges raised by new products, such as those from cell and gene therapy.

1:30 p.m. – 2:00 p.m.
The Future of Aseptic Processing: Parametric Aseptic Release
Frederic B. Ayers, Consultant Scientist,Eli Lilly and Company

2:00 p.m. – 2:30 p.m.
Aseptic Processing Controls and Simulation Design for Cell Therapies
Terrence J. Rindler, Associate Director, Validation, Juno Therapeutics

2:30 p.m. – 3:00 p.m.
Questions and Answers/ Discussion

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

3:45 p.m. – 4:30 p.m. 
P8: Panel Discussion: A Wrap Up of the Conference with Key Speakers, Experts, and Regulators
Moderator:
Hal Baseman, Chief Operations Officer, ValSource LLC

Session Description: The objective of this conference is to promote dialogue, deliver knowledge, and to leave attendees, participants, and speakers with a better understanding of the challenges, opportunities, and answers the sterile medicinal products manufacturing industry is and will be facing. Key speakers, experts, and regulators will take places at the podium to present final thoughts on conference proceedings and field questions from the audience. This is the attendees’ last opportunity to present their views and clarify presenter’s positions on topics presented or any topic related to the conference.

Gabriele Gori, Vice President, Audit and Risk Management, Global Quality, GSK Vaccines
Andrew Hopkins, Expert GDMP Inspector, Medicines and Healthcare Products Regulatory Agency
Richard Johnson, President and CEO, PDA
James Klein, PhD, Associate Vice President, Global Technical Operations S&V COE, Sterile Manufacturing Technical Operations, Merck & Co., Inc.
Marla Stevens-Riley, PhD, Master Microbiology Reviewer, Quality Assessment Lead, CDER, OPQ, FDA


4:30 p.m. – 5:00 p.m.
Closing Remarks from Conference Co-Chair
Hal Baseman, Chief Operations Officer, ValSource LLC


Conference Registration | May 14-15

Member

By March 5, 2018
$1,895

After March 5, 2018
$2,295

Non-member

By March 5, 2018
$2,174

After March 5, 2018
$2,574


Young Professional Member

Member

By March 5, 2018
$948

After March 5, 2018
$1,148


Government/Health Authority/Academic

Member

By March 5, 2018
$700

After March 5, 2018
$700

Non-member*

By March 5, 2018
$800

After March 5, 2018
$800


Student

Member

By March 5, 2018
$280

After March 5, 2018
$280

Non-member*

By March 5, 2018
$310

After March 5, 2018
$310


One Day Only Fee

Monday/Tuesday Only

Member
$1,348

Nonmember
$1,487

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 March 15, 2018 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 March 15, 2018, 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.

Hyatt Regency Bethesda

Hyatt Regency Bethesda
One Bethesda Metro Center
7400 Wisconsin Avenue
Bethesda, MD 20814 USA
Tel: +1 (301) 657-1234

Rate: Single/Double: $239.00, plus applicable state and local taxes.

The cut-off date has past, however rooms will are still available at the prevailing rate based on the hotel's availability.

Hotel Accommodations

A block of rooms have been reserved for meeting participants at the Hyatt Regency Bethesda. The rate is $239 for single or double occupancy. Guestroom rates are subject to State and Local taxes. Reservations must be secured by Monday, April 16, 2018. After this date, reservations can be made on a space-and rate-available basis only. Check-in time is 4:00 p.m.; check-out time is 12:00 p.m.

To make reservations, individuals may click on the reservation link above or call the Hyatt Regency Bethesda at +1 (301) 657-1234. Please make sure to tell the reservationist that you are with the PDA group attending the 2018 PDA Sterile Medicinal Products Conference to receive the PDA group rate.

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 24 hours prior to the date of arrival by 3 p.m. to avoid cancellation fees.

Amenities

Just one mile from the MD/DC line, Hyatt Regency Bethesda is perfectly-positioned to allow you to take advantage of all Washington, DC has to offer. Located directly above the Bethesda Metro station (Red Line), you're walking distance to numerous area businesses and minutes from Maryland's best shopping, dining and cultural attractions. Take advantage of the hotel's Smart Phone Check-in and the 24 hour StayFit™ fitness center during your stay. The Hyatt Regency offers complimentary Wi-Fi in all guestrooms and public areas.

Area Airports

Reagan National- (DCA) is located 12.7 miles from the hotel and all major carriers service this airport

Dulles International Ariport- (IAD) is 25 miles away, all major carriers service this airport

Baltimore Washington- (BWI) is 35.2 miles away, all major carries service this airport

Ground Transportation

Taxi fares from Reagan National (DCA) are approximately $45-55.00 one way, not including tip, and will take about 30 minutes. One way taxi fares from Dulles (IAD) is approximately $75 and from Baltimore/Washington (BWI) is about $95.

Driving Directions

Hyatt Regency Bethesda hotel is located on One Bethesda Metro Center.

Hotel Parking

Self-parking at the Hyatt Regency Bethesda is $12 daily/overnight. Valet parking is $18 daily or $30 overnight.

Sponsorship and Exhibit Opportunities are Available!

The 2018 PDA Sterile Medicinal Products Manufacturing Conference offers exciting and unique sponsorship and exhibition packages designed to strengthen brand image, increase visibility, and help you connect with industry leaders. This workshop will bring together industry experts from Manufacturing, Formulation, Compliance, Sterile Operations, Engineering, QA/QC, Development, Regulatory Affairs, Research and Development, Technical Operations, Validation, and Microbiology.

Good foot traffic is one thing; good leads are another. At this conference you will be exposed to high quality attendees from a variety of manufacturing companies – making this a must attend meeting. In addition, high profile sponsorships are available for lanyards, notepads, audience response systems, tote bags, pens, refreshment breaks, lunch and networking reception. We’ll create a customized sponsorship to fit your needs and budget.

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

David Hall, Vice President, Sales

Tel: +1 (301) 760-7373
Cell: +1 (240) 688-4405
Fax: +1 (301) 986-0296
Email: hall@pda.org

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