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Parenteral Drug Association Connecting People, Science and Regulation ®

2018 PDA/FDA Joint Regulatory Conference

Putting Patients First: Ensuring Innovation, Quality, Compliance, and Supply in an Evolving Environment
Sep 24 - Sep 26, 2018 |
Sep 26, 2018 |
Renaissance Washington, DC Downtown Hotel | Washington, DC
  • Conference
  • Western Hemisphere Events
Exhibition: September 24-25
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The PDA/FDA Joint Regulatory Conference is now in its 27th year. This important conference provides a forum for discussions centered on the requirements that assure the availability and delivery of high-quality medical products, and offers an opportunity to hear about the latest issues in the regulatory, quality, supply, and compliance areas for medical products in an ever-evolving landscape. Attendees will hear straight from regulators and industry leaders about how to meet the challenges of developing, manufacturing, and assuring availability and safe supply of necessary medicines to serve the patient.

In keeping with the focus on putting patients first, this Conference will explore topics that ensure innovation, quality, compliance, and a continued supply of important drugs, biologics, and combination products. The past year, 2017, presented the medical products industry with many challenges in assuring a continued supply of necessary medical products. These challenges included major natural disasters and disruptions that affected manufacturing and supply chains. Combined efforts of industry and regulators were necessary to assure uninterrupted supplies of safe and high-quality products in the face of such challenges. 

It light of the fact that it is nearly 10 years since the heparin incidents, the Conference will address issues affecting the supply chain and the evolving regulatory landscape. Solutions that have been successful in keeping the supply chain secure, assuring quality of medicinal products, and achieving compliance with regulatory and quality expectations as they continue to evolve, will also be explored. 

The Conference program will include discussions on combination products, aging facilities, quality risk management, post-approval changes and life-cycle management, process validation, and challenges of regulatory application submissions. Attendees will also learn about hot topics, such as aseptic processing, managing enforcement actions (e.g., consent decrees), inspection updates, quality systems, and quality trending, among others.

Sessions will include many case studies and practical solutions to current supply challenges, such as shortage prevention and disaster recovery, management of contract manufacturers, supplier oversight, supply chain challenges for innovative products (e.g., cell and gene therapy), and supply chain safety. The traditional and ever-popular presentations of each of the FDA’s medical product areas to discuss program specific initiatives and compliance updates will also be included. There will also be speakers from other regulatory agencies and global industry leaders who will explore the issues facing companies that operate globally.

Monday, September 24

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

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

8:00 a.m.-10:00 a.m.
P1: Taking Stock of the Drug Supply Chain
Moderator: Richard L. Friedman, MS, Deputy Director, OMQ, CDER, FDA

This year's conference occurs ten years after the heparin supply chain crisis. Since that time, industry has made major efforts to improve supply chain management, while also adjusting to further changes in the global market. In addition to industry's evolution, the passage of the landmark FDASIA legislation in 2012, and subsequent amendments to the Act, provided FDA with modern authorities that help the agency to better regulate quality and safety of drugs in the global supply chain. 

This opening plenary session will focus on current priorities of regulators and industry in the area of drug product supply, with focus on effective risk management of today's complex global supply chain to assure dependable manufacturing, quality, and availability of medicines.  Regarding the latter, the value of synergistic partnerships between industry and regulators to ensure adherence to strong public health standards for safety and effectiveness, while also accelerating access to groundbreaking medical products, will also be discussed.

9:45 a.m. – 8:00 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.
P2: The Evolving Regulatory Landscape
Moderators: Rebecca Devine, PhD, Regulatory Consultant

This session will provide a high-level overview of the major regulatory initiatives at the U.S. FDA and in the EU. FDA will provide updates on topics such as Program Alignment, organizational changes, key inspectional priorities, and response to supply chain disruptions. The session will also cover EU hot topics, including changes in the EU with the impact of BREXIT, the EMA headquarters move, and other global issues affecting the pharmaceutical supply chain and drug availability. The presenters will also discuss harmonization topics, including Mutual Recognition Agreements (MRA) and PIC/S collaboration.

10:45 a.m. – 11:15 a.m.
Alonza E. Cruse,
Director, Office of Pharmaceutical Quality Operations, ORA, FDA

11:15 a.m. – 11:45 a.m.
John Lynch, MSc, MPSI, Director of Compliance, Health Products Regulatory Authority

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

12:30 p.m. – 1:30 p.m.
Interest Groups

1:45 p.m. – 3:15 p.m.
Concurrent Sessions

LIFECYCLE MANAGEMENT AND INNOVATION

A1: Combination Products
Moderator: Lucy Cabral, Senior Director, Global External Quality, Roche – Genentech

Are you ready with the controls and processes needed to qualify and manage your smart devices as part of Combo Products? Do your processes and systems meet the regulatory agency expectations? What do we need to put in place for smart devices?

1:45 p.m. – 2:15 p.m.
Anthony L. Schaff, Sr., Senior Engineering Advisor, Eli Lilly and Company

2:15 p.m. – 2:45 p.m.
CAPT Scott A. Colburn, MS, Director, CDRH Standards Program, CDRH, FDA

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

QUALITY AND COMPLIANCE

B1: Aseptic Processing/Annex 1
Moderator: Carol L. Rehkopf, Chief, Review Management Business Operations Staff, CBER, FDA

The global healthcare system relies on numerous critical injection products to cure and mitigate disease and illness. Most of these injections are made by aseptic processing, rather than terminal sterilization. Substandard manufacturing conditions at an aseptic processing facility can pose a risk to patients both due to contamination hazards and supply shortfalls. This session will address the technological and risk management framework that assures robustness in an aseptic processing operation. It will also explore current regulatory expectations, and include an update on the Annex 1 revision.

SUPPLY CHAIN

C1: Effective Supplier Quality Audit Programs
Moderator: David J. Jaworski, MBA, Senior Policy Advisor, CDER, FDA

The quality of a company’s drug products is directly connected to the strength and quality of its suppliers and partners. Therefore, the effectiveness of a supplier quality audit program is critical to a firm’s success. The speakers at this session will explore practices used to identify partners and suppliers that share the same quality standards. The speakers will also discuss how to integrate risk-based approaches to effective audit programs, and they will share best practices used as a supply chain program is developed.

1:45 p.m. – 2:10 p.m.
James M. Fries, MBA, CEO, Rx-360

2:10 p.m. – 2:35 p.m.
Ranjani Prabhakara, PhD, Team Leader, CDER, FDA (Invited)

2:35 p.m. – 2:55 p.m.
Amelia L. Mutere, MS, Head Global Quality Inspection Management, Genentech/Roche (Invited)

2:55 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.
Concurrent Sessions

LIFECYCLE MANAGEMENT AND INNOVATION

A2: Aging Facilities and Quality Risk Management
Moderator: Paul Perdue, Jr., Branch Chief, Pharmaceutical Quality Program Operations Branch, ORA, FDA

Manufacturing capability and quality problems are a major factor in shortages of drugs. While this problem can be greatly solved by upgrades in a company’s manufacturing facilities, needed upgrades are often slowed by a company’s lack of understanding of current technologies or insufficient commitment to invest in more reliable manufacturing equipment. This session will discuss real world industry case studies of manufacturing upgrades and the economic benefits of these upgrades. The session will also discuss the amenability of regulators to higher capability manufacturing operations through adoption of modern technology and opportunities for regulatory flexibility.

4:00 p.m. – 4:30 p.m.
Peter Gallagher, MBA, Vice President, Strategic Affairs, Teligent, Inc.

4:30 p.m. – 5:00 p.m.
Ronald Berk, Chief Technology Officer, Hyde Engineering + Consulting (Invited)

5:00 p.m. – 5:30 p.m.
Panel Discussion with Presenters and Additional Participants
Anthony F. Lorenzo, Lead Consumer Safety Officer, CBER, FDA
John Lynch, MSc, MPSI, Director of Compliance, Health Products Regulatory Authority (Invited)

QUALITY AND COMPLIANCE

B2: A Successful Journey under Consent Decree
Moderator: David Doleski, Compliance Head for Biologics Quality Operations, Sanofi

This session will explain how consent decrees are negotiated and the possible elements of a consent decree. Sanofi will describe its journey after Genzyme entered into a consent decree and its acquisition and remediation of the facility. Systematic improvements in the quality culture and quality systems have resulted from this long-term remediation effort. Insight into the ongoing efforts and success factors driving this metamorphosis will be explained by senior leadership.

4:00 p.m. – 4:15 p.m.
David L. Chesney, Principal and General Manager, DL Chesney Consulting, LLC

4:15 p.m. – 5:00 p.m.
Brandon Varnau, Head of Quality Operations Biologics Platform, Global Quality, Sanofi

5:00 p.m. – 5:30 p.m.
Questions and Answers/Discussion

SUPPLY CHAIN

C2: CMO Oversight: Challenges and Opportunities
Moderator: Tim G. Kilroy, PhD, Director, Global Quality Audits, BristolMyersSquibb

This session will explore the area of CMO oversight and delve into the challenges and best practices of performing quality oversight of externally sourced contract manufacturers and partners. Themes will include risk-based approaches to Quality oversight, partnering with the business to build strategic partnerships, and due diligence processes in qualifying CMOs. Speakers will present both industry and regulatory perspectives using case studies.

4:00 p.m. – 4:30 p.m.
Brooke K. Higgins, MS, Senior Policy Advisor, CDER, FDA (Invited)

4:30 p.m. – 5:00 p.m.
Mary Collins, PhD, Executive Director, Quality, External Manufacturing, BristolMyersSquibb

5:00 p.m. – 5:30 p.m.
Questions and Answers/Discussion

5:45 p.m. – 6:45 p.m.
Concurrent Interest Group Sessions

6:45 p.m. – 10:00 p.m.
Networking Reception

Tuesday, September 25

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

7:00 a.m. – 8:30 a.m.
Continental Breakfast

7:15 a.m. – 8:15 a.m.
Concurrent Breakfast Sessions

Breakfast 1: Microbiology Issues
Moderator: Clarice Haigh Hutchens, PhD, Director, Global Chemistry Manufacturing Control Advisory Office, Worldwide Safety and Regulatory, Pfizer Biotech

In this session, presenters will discuss common microbiology issues: endotoxin method challenges, such as LER; investigating micro deviations; low bioburden EM and regulators’ expectations; viral testing and innovative technology.

7:15 a.m. – 7:35 a.m.
Jennifer M. Gogley, Microbiologist, ORA, FDA (Invited)

7:35 a.m. – 7:55 a.m.
Industry Representative Invited

7:55 a.m. – 8:15 a.m.
Questions and Answers/Discussion

Breakfast 2: Container Closure Integrity Testing
Moderator: Mai X. Huynh, MS, Supervisory Team Leader, Antimicrobial Team, CVM, FDA

The assurance of product quality depends on the ability of the product to maintain integrity throughout the stresses anticipated during storage, distribution, and use, and therefore, satisfactory package integrity is a critical parameter for all parenteral products. Choosing the appropriate integrity test method for your container closure can be a challenge. This session will provide some key points to consider when selecting traditional versus more recent or advanced leak test methods, including discussion on feedback received since the revision of USP <1207>, Package Integrity Evaluation – Sterile Products.

7:15 a.m. – 7:35 a.m.
Container Closure Integrity Testing <USP 1207>
Donald C. Singer,
Senior Fellow, Biopharmaceutical GMP Operations, GlaxoSmith Kline

7:35 a.m. – 7:55 a.m.
Christine Harman, PhD, Chemist, CBER, FDA

7:55 a.m. – 8:15 a.m.
Panel Discussion with Presenter and Additional Panelists
Jason A. Rossi, MS,
Review Chemist, Division of Manufacturing Technologies, CVM, FDA (Invited)
Marla Stevens-Riley, PhD, Master Microbiology Reviewer, Quality Assessment Lead, CDER, FDA (Invited)

Breakfast 3: Breakfast with the FDA
Moderator: Douglas A. Campbell, Senior Consultant, InterPro QRA

Set your alarm to attend this eye-opening breakfast session that will allow for your direct input and provide you with insights regarding inspections trends and center initiatives, including serialization. This session gives you the chance for an informal Q&A with FDA Investigators and Center representatives during your attendance at this premier pharmaceutical manufacturing event.

Breakfast 4: 503B Compounding
Moderator: Susan Schniepp, Fellow, Regulatory Compliance Associates Inc.

Come and hear the latest information and developments regarding 503B Pharmacy Compounders (Outsourcing Facilities). PDA’s compounding pharmacy expert, Chris Smalley, and one of FDA’s experts in this area, Ian Deveau, will discuss the regulations affecting 503B facilities. Their presentations will be followed by an audience participation question and answer session.

7:15 a.m. – 7:45 a.m.
Christopher J. Smalley, PhD, Compounding Pharmacist Advisor, ValSource, LLC

7:45 a.m. – 8:15 a.m.
Panel Discussion with Presenter and Additional Panelist
Ian F. Deveau, PhD,
Supervisory Consumer Safety Officer, CDER, FDA

8:30 a.m.-10:0 a.m.
P3: Compliance Update
Moderator: David Doleski, Compliance Head for Biologics Quality Operations, Sanofi

This session is one of the highlights of the Conference, featuring Compliance Directors from the FDA Centers and Office of Regulatory Affairs. It will focus on problems areas that FDA has found during inspections, significant regulatory actions initiated, and FDA’s current enforcement strategy for a wide array of regulated products. FDA’s top leaders in Compliance and Enforcement will describe their programs and initiatives related to inspection and compliance activities. This is the best possible opportunity for you to understand FDA’s thinking and expectations for GXP compliance of the industry. Most importantly, there will be ample time for the audience to ask probing questions of FDA’s top leadership. This very popular session is one you cannot afford to miss.

Panel Discussion
Donald D. Ashley, JD,
Director, Office of Compliance, CDER, FDA
CAPT Sean Boyd, Deputy Director for Regulatory Affairs, Office of Compliance, CDRH, FDA
Martine Hartogensis, DVM, Deputy Director, Office of Surveillance and Compliance, CVM, FDA
Melissa J. Mendoza, Deputy Director, Director, Office of Compliance and Biologics Quality, CBER, FDA
Douglas W. Stearn, JD, Director, Office of Enforcement and Import Operations, FDA (Invited)

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.
Concurrent Sessions

LIFECYCLE MANAGEMENT AND INNOVATION

A3: Product Lifecycle Management and Q12
Moderator: Commander Tara Gooen Bizjak, MS, Senior Science Policy Advisor for Pharmaceutical Quality, CDER, FDA

A single post-approval change can take three to five years to implement across all regions, resulting in additional costs and potential supply disruption. Does Q12, with Established Conditions, Post-approval Change Management Protocols (PACMPs), and Product Lifecycle Management Plans, lay out a path forward to further incentivize manufacturers to make improvements, increase process robustness, and facilitate change implementation? The speakers at this session will focus on case studies relevant to brand small molecule, biotech, and generic products. The speakers will also provide an update on the associated PDA technical report. The session will close with a panel discussion and include a regulatory perspective.

10:45 a.m. – 11:00 a.m.
Shannon Holmes, PhD, RAC, Associate Director, Regulatory Affairs CMC, Biogen Idec (Invited)

11:00 a.m. – 11:15 a.m.
Industry Representative Invited

11:15 a.m. – 11:40 a.m.
Industry Representative Invited

11:40 a.m. – 12:15 p.m.
Panel Discussion with Presenters and Additional Participants
Ashley B. Boam, MSBE,
Deputy Director, Office of Pharmaceutical Science, CDER, FDA (Invited)
Ingrid Markovic, PhD,
Senior Science Advisor for Chemistry Manufacturing and Controls (CMC), CBER, FDA (Invited)

QUALITY AND COMPLIANCE

B3: Inspections and Compliance Update
Moderator: David L. Chesney, Principal and General Manager, DL Chesney Consulting, LLC

It's back by popular demand! This session will include short presentations from CDER and CBER Compliance Managers that are designed to provide more than just the usual "Top 10" 483 observations and a summary of the latest warning letters. These presentations will be followed by a panel discussion with panelists from each of the Agency's Centers and will be an opportunity for participants to gather specific insight.

SUPPLY CHAIN

C3: Shortage Prevention and Availability: Disaster Recovery Case Studies
Moderator: Renée Kyro, MBA, Director Share Services, Quality Assurance, Abbvie Inc.

2017 was an unprecedented year of natural disasters, with earthquakes in Mexico; wild fires in California; record flooding from monsoons and torrential rainfall across the globe; and hurricanes in Texas, Florida, and Puerto Rico. These events presented significant challenges for our industry to provide assurance of supply to our patients and the handling of drug shortages. Hear from industry leaders and regulators on lessons learned and case studies from some of these catastrophic events.

10:45 a.m. – 11:15 a.m.
Industry Representative Invited

11:15 a.m. – 11:45 a.m.
Christopher M. Jones, MBA, Vice President, Operations Strategy and External Contract Manufacturing, Baxter Healthcare Corporation (Invited)

11:45 a.m. – 12:15 p.m.
Panel Discussion with Presenters and Additional Participants
CAPT Valerie E. Jensen, RPh,
Associate Director of the Drug Shortage Staff, CDER, FDA (Invited)
Andrei E. Nabakowski, PharmD,
Director, Office of Emergency Operations, OC, FDA (Invited)

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

12:30 p.m. – 1:30 p.m.
Interest Groups

1:45 p.m. – 3:15 p.m.
Concurrent Sessions

LIFECYCLE MANAGEMENT AND INNOVATION

A4: Process Validation Implementation: Taking Stock, Where are We?
Moderator: Mai X. Huynh, MS, Supervisory Team Leader, Antimicrobial Team, CVM, FDA

Where are we with the process validation since the publication of the 2011 FDA Guidance for Industry, “Process Validation – General Principles and Practices?” This session offers an opportunity for industry and FDA to share their experience regarding how the principles and approaches described in the current guidance apply to the manufacturing process from process design, process qualification, and continued process verification. The session will share lessons learned from both the industry and FDA perspectives.

1:45 p.m. – 2:15 p.m.
Kenneth D. Hinds, PhD, Director, Drug Product Development, Janssen R&D, LLC

2:15 p.m. – 2:45 p.m.
Regulatory Representative Invited

2:45 p.m. – 3:15 p.m.
Panel Discussion with Presenters and Additional Participants
Alexey Khrenov, PhD, Senior Staff Fellow, CBER, FDA
Michael J. Popek, Team Leader, Division of Manufacturing Technologies, CVM, FDA

QUALITY AND COMPLIANCE

B4: Trending for Quality
Moderator: Myriam M. Sosa, MS, AVP, GMP Audit and Compliance, Merck & Co.

Trending of quality data can be used to control processes to maintain their validated state and to monitor process performance for early detection of excursions from the validated state. Data for trending includes process parameters, materials, performance and quality indicators as well as complaint data. Methods include Shewhart control charts and more advanced trending tools like CUSUM charts and change-point analysis. Methods are available for both attribute (pass/fail) data and measurable characteristics. The basic process of setting up a trending program, from deciding what to trend, how to trend it and actions to take will be covered.

1:45 p.m. – 2:15 p.m.
Wayne A. Taylor, PhD, Chairman, Taylor Enterprises, Inc.

2:15 p.m. – 2:45 p.m.
Commander Tara Gooen Bizjak, MS, Senior Science Policy Advisor for Pharmaceutical Quality, CDER, FDA (Invited)

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

SUPPLY CHAIN

C4: Supply Chain Issues and Innovative Products for Cell and Gene Therapy
Moderator: John D. Ayres, MD, JD, Senior Medical Fellow, Product Safety Assessments, Global Patient Safety, Eli Lilly and Company

Innovation in cell- and gene-based therapeutics continues to advance rapidly. It is critical that supply chain and product integrity systems evolve to meet the unique demand these products present. Supply chain security is critical to avoid environmental excursions, trauma, or diversion. For cell therapies, although both allogeneic and autologous cell sources are utilized therapeutically, autologous cells present significant chain-of-custody challenges that must be demonstrated as fail-safe to ensure that the donor-recipient match (needle-to-needle) is maintained. Likewise, gene therapy presents its own unique issues related to viral and non-viral vectors and associated challenges. This session will explore these issues and considerations around integrating cGMP and quality systems for cell and gene therapy products, and recent FDA guidance for these therapies.

1:45 p.m. – 2:15 p.m.
Regulatory Representative Invited

2:15 p.m. – 2:45 p.m.
John Lunger, MBA, Vice President, Manufacturing and Supply Chain, Adaptimmune Therapeutics

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.
Concurrent Sessions

LIFECYCLE MANAGEMENT AND INNOVATION

A5: Hot Topics in Submissions
Moderator:Reyes Candau-Chacon, PhD, Biologist, CDER, FDA and Laurie P. Norwood, Deputy Director, Division of Manufacturing Product Quality, OCBQ, CBER, FDA

How are industry and FDA adapting to meeting the shorter review timeframes for applications required for breakthrough products regulated by CBER and CDER? Are there new challenges in the review and inspection process of biosimilar applications? What are the FDA expectations for new transition biological products? In this session, FDA and Industry will present case studies that will address manufacturing and product quality challenges encountered with new types of biologicals products and new manufacturing platforms.

4:00 p.m. – 4:30 p.m.
Bo Chi, Microbiologist, CDER, FDA

4:30 p.m. – 5:00 p.m.
Joan Kwong, MS, Senior Manager, Global Regulatory Affairs, Pfizer Essential Health

5:00 p.m. – 5:30 p.m.
Panel Discussion with Presenters and Additional Participants
Anthony F. Lorenzo,
Lead Consumer Safety Officer, CBER, FDA

QUALITY AND COMPLIANCE

B5: Quality Systems
Moderator: Enrique Diloné, PhD, RAC, Senior Vice President, Technical Operations, Amicus Therapeutics, Inc.

In this session, speakers will discuss quality issues facing biotech companies. Biotech companies in clinical development may not have a fully established quality management system (QMS). Their quality functions may be challenged to meet increasing compliance requirements while enabling business objectives in highly dynamic environments. As biotech companies mature from clinical development into global commercial operations, the QMS and quality culture must evolve to meet the changing needs of the business. Case studies will be presented in a separate session demonstrating how the evolution of the QMS enabled increased oversight of their outsourced biologics manufacturing and the maturation of quality culture required to ensure product safety and quality.

4:00 p.m. – 4:30 p.m.
Jan Paul Zonnenberg, Partner, PriceWaterhouseCoopers, LLC

4:30 p.m. – 5:00 p.m.
Laura Singer, Vice President, Global Quality Assurance, Amicus Therapeutics

5:00 p.m. – 5:30 p.m.
Panel Discussion with Presenters and Additional Participants
Grace E. McNally,
Supervisory Health Scientist, CDER, FDA (Invited)

SUPPLY CHAIN

C5: Ingredient Supplier Oversight
Moderator: Lucy Cabral, Senior Director, Global External Quality, Roche – Genentech

How robust is your company’s process for qualification, management and risk reduction of your suppliers of API and Excipients? Does your process prevent quality failures and ensure uninterrupted supply to the patients your company serves? In this session, participants will hear from Dr. Ralph Quadflieg as he presents a risk-based approach to manage API and excipients and address best practices managing a large portfolio of materials and suppliers. Dr. Marla A. Phillips will follow with a presentation on how to improve supply chain security, root causes for supplier issues in the industry, and good supplier practices.

4:00 p.m. – 4:30 p.m.
Ralph Quadflieg, PhD, Regional Head Global Supplier Quality Management, Roche

4:30 p.m. – 5:00 p.m.
Marla A. Phillips, PhD, Director, Xavier Health, Xavier University

5:00 p.m. – 5:30 p.m.
Questions and Answers/Discussion

5:45 p.m. – 6:45 p.m.
Concurrent Interest Group Sessions

Wednesday, September 26

7:00 a.m. – 12:00 p.m.
Registration Open

7:00 a.m. – 8:30 a.m.
Continental Breakfast

7:15 a.m. – 8:15 a.m.
Concurrent Breakfast Sessions

Breakfast 5: Green Chemistry and Product Sustainability
Moderator: Clarice Haigh Hutchens, PhD, Director, Global Chemistry Manufacturing Control Advisory Office, Worldwide Safety and Regulatory, Pfizer Biotech

This session will focus on three dimensions of sustainability relevant to Pharma— (1) EHS Site Facilities’ focus on energy, waste, and water; (2) researchers’ focus on green chemistry and sustainable processes; and (3) product sustainability and branding perspective with approaches to telling the “story.”

7:15 a.m. – 7:30 a.m.
Industry Representative Invited

7:30 a.m. – 7:45 a.m.
ACS Green Chemistry Initiative Member Invited 

7:45 a.m. – 8:00 a.m.
Tom Polton, MS, Environmental Sustainability and Product Stewardship, Senior Director, Global EHS, Pfizer (Invited)

8:00 a.m. – 8:15 a.m.
Questions and Answers/Discussion

Breakfast 6: Evolving Large Volume Parenteral Manufacturing
Moderator: Jacqueline Kunzler, MBA, PhD, Senior Vice President, Chief Quality Officer, Baxter

This session will review the history of large volume parenteral (LVP) manufacturing and contemplate where the future should lead. What is the Agency’s perspective on areas that need additional focus in LVP manufacturing? How can industry drive meaningful change in a commoditized market?

7:15 a.m. – 7:45 a.m.
Visual Inspection Advancements in Flexible Packaging
Merle Goddard, MS,
Senior Director, Global Quality, Baxter

7:45 a.m. – 8:15 a.m.
Panel Discussion with Presenter and Additional Participants
Karen E. D'Orazio,
Compliance Officer, CDER, FDA
Reynold Tan, PhD, Quality Assessment Lead, CDER, FDA

Breakfast 7: Restricted Access Barrier Systems and Isolators: Current Perspectives
Moderator: David J. Jaworski, MBA, Senior Policy Advisor, CDER, FDA

This session is focused on the significant sterility assurance benefits of using restricted access barrier and isolator systems to manufacture sterile biologic and drug products. These systems, when used and maintained properly, are exceptional; however, as the speakers will discuss, there are issues that affect the quality of the drugs manufactured within them.

7:15 a.m. – 7:45 a.m.
Anne Huffman, Vice President Quality Assurance - Plant Operations, Fresenius Kabi USA, LLC (Invited)
Anthony Pavell,
Plant Manager - PU GI, Fresenius Kabi USA, LLC (Invited)

7:45 a.m. – 8:15 a.m.
Questions and Answers/Discussion

Breakfast 8: Water Systems
Moderator: Shane Killian, MS, Senior Director, Licensing & Acquisition Head, Johnson & Johnson

Maintaining a qualified pharmaceutical water system requires key design elements and a reliable maintenance plan, especially if you are dealing with an aging facility. This session will bring us “back to basics” with water system types, design elements, maintenance, and monitoring.

7:15 a.m. – 7:45 a.m.
Stephen E. Langille, PhD, Acting Division Director, Division of Microbiology Assessment, Office of Process and Facilities, CDER, FDA (Invited)

7:45 a.m. – 8:15 a.m.
Questions and Answers/Discussion

Breakfast 9: Training Effectiveness
Moderator: Douglas A. Campbell, Senior Consultant, Interpro QRA and Susan Schniepp, Fellow, Regulatory Compliance Associates Inc.

There is a common effort throughout the industry to better manage the training program. There is also a general understanding of the cycle of training/ re-training as a component of many corrective actions. This session is designed to provide insight related to the evaluation of the effectiveness of training. These types of evaluations can provide value added, not only to the training program and the qualifications of the employees, but also to the organization through the direct benefits of a reduction in deviations, OOS, etc. Participants in this session will take away a simple concept that could provide a modern outlook and improvement to the training program.

7:15 a.m. – 7:45 a.m.
Kristy Zielny, Director, Regional Quality & Compliance North America, Sun Pharmaceutical Industries, Inc.

7:45 a.m. – 8:15 a.m.
Questions and Answers/Discussion

8:30 a.m. – 10:00 a.m.
P4: Center Updates
Moderator: Laurie P. Norwood, Deputy Director, Division of Manufacturing Product Quality, OCBQ, CBER, FDA

How is FDA adapting to the evolving environment of regulating new innovative drugs and devices and ensuring product quality, compliance, and product to the patients? Hear from FDA senior management officials from various FDA Centers and learn about their new initiatives, challenges, and plans as the Agency moves forward to maintain a constant supply of approved products and to bring new and novel products to the market. A panel discussion will follow, along with time for questions from the audience.

Panel Discussion
CAPT Sean Boyd,
Deputy Director for Regulatory Affairs, Office of Compliance, CDRH, FDA
Peter W. Marks, MD, PhD, Director, Center for Biologics Evaluation and Research, FDA
Steven Solomon, DVM, Director, Center for Veterinary Medicine, FDA

10:00 a.m. – 10:30 a.m.
Refreshment Break

10:30 a.m. – 12:15 p.m.
P5: Closing Penary
Moderators: Valerie Whelan, Vice President, Corporate Quality, Amgen Inc.

12:15 p.m.
Looking to the Future: Announcement of 2019 Co-chairs and Focus on the Coming Year

Conference Registration | September 24-26, 2018

Member

By July 16, 2018
$2,395

After July 16, 2018
$2,995

Non-member

By July 16, 2018
$2,674

After July 16, 2018
$3,274


Young Professional Member

Member*

By July 16, 2018
$1,198

After July 16, 2018
$1,498


Government/Health Authority† 

Member*

By July 16, 2018
$700

After July 16, 2018
$700

Non-member*

By July 16, 2018
$700

After July 16, 2018
$700


Academic

Member

By July 16, 2018
$700

After July 16, 2018
$700

Non-member*

By July 16, 2018
$800

After July 16, 2018
$800


Student

Member

By July 16, 2018
$280

After July 16, 2018
$280

Non-member*

By July 16, 2018
$310

After July 16, 2018
$310


One Day Only Fee

Monday, September 24 | Tuesday, September 25

PDA Member
$1,398

Nonmember
$1,510

All prices in US dollars.

If you are a Government/Health Authority Member Type, you must use the Government/Health Authority Registration Form. The cost of food functions is $350.

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

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 Conference.

Group Registration Discount

Register 3 people from the same organization as a group (at the same time) for the Conference and receive the 4th registration free. Other discounts cannot be applied. Complimentary Conference registration does not qualify for discount offered for Workshop.

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 July 26, 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 on site at the prevailing rate. 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). If your written request in received on or before July 26, 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 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 onsite. 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. Recordings are prohibited at all PDA Conferences.

Renaissance Washington, DC Downtown Hotel
999 9th Street NW
Washington, DC 20001
Phone: +1 (202) 898-9000


Rate: Single: $317.00, plus applicable taxes (14.5%).

Cut Off Date: Friday, August 10 (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 Renaissance Washington, DC Downtown Hotel, please call the Hotel at +1 (202) 898-9000 and reference the 2018 PDA/FDA Joint Regulatory Conference to receive the PDA group rate. Check in time is 4:00 p.m. and check out time is 12:00 p.m.

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 6 p.m. on the date of arrival otherwise specified on your reservation information.

Amenities

The Renaissance Washington, DC Hotel is located in Penn Quarter; in the heart of downtown Washington DC. Local attractions include the National Portrait Gallery, Smithsonian Institute and Air Space Museum, Washington Monument, Capitol Hill, and many more. All 794 guest rooms and suites provide high-speed Internet, upgraded Luxurious bedding, coffee makers, hair dryers, iron, and an ironing board.

Travel

Area Airports
Ronald Reagan Washington National (DCA) is approximately 5 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 32 miles away.

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

Metro
Gallery Place Metro Station is 0.5 miles away from the hotel and is approximately $2.50 one way to Reagan National.

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

Driving
Renaissance Washington, DC Downtown Hotel is located on 999 9th Street NW off of New York Avenue.

Hotel Parking
$35 / Daily Self-Parking
$45 / Daily Valet Parking

Sponsorship and Exhibit Opportunities are Available!

The 2018 PDA/FDA Joint Regulatory Conference offers exciting and unique sponsorship and exhibition packages designed to strengthen brand image, increase visibility, and help you connect with industry leaders. This Conference will bring together industry experts from, quality, compliance, operations, supply chain, engineering, project management, manufacturing, regulatory affairs, and science professionals.

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

Register Now
https://store.pda.org/Meetings/Login.aspx?ID=3903

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