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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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Speaker Biographies

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

7:00 a.m. – 8:00 a.m.
PDA Orientation Breakfast (Invitation Only)
Supported in part by Amgen Inc.                                                                                         

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

8:15 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 10 years after the heparin supply chain crisis. Since that time, industry has enhanced supply chain management while also adjusting to further evolutions in the global market. In addition to industry’s progression, the passage of the landmark FDASIA legislation in 2012, and subsequent amendments to the Act, provided the 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 a focus on effective risk management of today’s complex global supply chains to assure reliable manufacturing, quality, and availability of medicines. Each of these are integral to “Putting Patients First.” The value of synergistic partnerships between industry and regulators to ensure strong public health standards for safety and effectiveness, while also accelerating access to groundbreaking medical products will also be discussed.

8:15 a.m. – 8:30 a.m.
Welcome and Opening Remarks from PDA Leadership and Conference Co-Chairs
Richard Johnson, President & CEO, PDA
Rebecca Devine, PhD, Regulatory Consultant and Chair, PDA Board of Directors
Richard L. Friedman, MS, Deputy Director, OMQ, CDER, FDA

8:30 a.m. – 9:00 a.m.
FDA Update on Supply Chain Risks and Opportunities
Anna Abram, Deputy Commissioner for Policy, Planning, Legislation and Analysis, FDA

9:00 a.m. – 9:30 a.m.
Our Commitment to Patients: Ensuring Supply for Every Patient, Every Time
Esteban Santos, MS, Executive Vice President, Operations, Amgen, Inc.

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

10:00 a.m. – 10:45 a.m.
Refreshment Break in Exhibit Area
Supported in part by Sparta Systems, Inc.

10:45 a.m.-12:15 p.m.
P2: The Evolving Regulatory Landscape
Moderator: Rebecca Devine, PhD, Regulatory Consultant

This session will provide a high-level overview of the major regulatory initiatives at the 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. Boxed lunches will also be available for purchase.

12:30 p.m. – 1:30 p.m.
Concurrent Interest Group Sessions

IG1: Pharmacopoeial

Global Needs, Global Patients
We live in a world where supply chains are complex, and patients are global. We need to continue to evolve and be creative regarding the compendial standards and work towards innovative solutions for the future.

IG2: Regulatory Affairs

Medicine and vaccine shortages: What is the role of global regulatory complexity for post approval changes?
Supply shortages of medically necessary products still pose a significant challenge to public health. FDA announced in July 2018 the creation of a new drug shortages task force to strike at underlying structural issues that cause persistent shortages of critical medicines.

In June 2018, The Economist Intelligence Unit (EIU) published a PDA-funded research report on "Medicine and vaccine shortages: What is the role of global regulatory complexity for post approval changes?". The report explores whether the varying regulatory requirements for pharmaceutical products across the world are associated with medicine and vaccine shortages.

In this session, key messages from the findings of the literature review and insights from the expert interviews will be presented. The presentation will be followed by an interactive panel discussion.

IG3: Supply Chain

Current Topics in Supply Chain Management: Supplier Quality Management of Materials, Hot Topics, and Evolving Regulations in China

Putting patients first: how safe and secure are the raw materials, excipients and components since the Heparin event? What progress has the industry made in 10 years to prevent adulteration of ingredients? Focus will be made on hot topics in supply chain and focus on the emerging China regulations.

Drug counterfeits in emerging markets are still on the rise. Are drug makers using innovative ideas to prevent/combat counterfeits for all patients around the world? Are counterfeits preventing patients from getting needed drugs in some parts of the world, e.g., Africa?

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


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

Do you have a strong understanding of combination products requirements? Do your processes and systems meet the regulatory agency expectations? What do we need to put in place for smart devices? In this session, presentations will address both standards and connectivity with existing devices.

1:45 p.m. – 2:15 p.m.
Considerations in Development of Delivery Devices and Connected Solutions
Anthony L. Schaff, Sr., PE, Senior Engineering Advisor, Eli Lilly and Company

2:15 p.m. – 2:45 p.m.
Current Regulatory Standards Related to Connected Systems
CAPT Scott A. Colburn, MS, Director, CDRH Standards Program, CDRH, FDA

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


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 ensures robustness in an aseptic processing operation. It will also explore current regulatory expectations and include an update on the Annex 1 revision.

1:45 p.m. – 2:15 p.m.
Sterile Manufacturing: An MHRA Inspector’s Perspective, Including an Annex 1 Update
Tracy Moore, GMDP Operations Manager and Senior Inspector, Inspection Enforcement and Standards Division, Medicines and Healthcare Products Regulatory Agency (MHRA)

2:15 p.m. – 2:45 p.m.
FDA Regulatory Perspective on Aseptic Processing: Ensuring Quality of Sterile Drug Products
Virginia Carroll, PhD, Microbiologist, CDER, FDA

2:45 p.m. – 3:15 p.m.
Panel Discussion with Presenters and Additional Participant
Hal Baseman, Chief Operating Officer, ValSource, LLC


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 into effective audit programs, and they will share best practices for sustaining an effective supply chain oversight program.

1:45 p.m. – 2:15 p.m.
Industry Perspective on Effective Supplier Quality Audit Programs
James M. Fries, MBA, CEO, Rx-360

2:15 p.m. – 2:45 p.m.
Regulatory Perspective on Effective Supplier Quality Audit Programs
Ranjani Prabhakara, PhD, Team Leader, CDER, FDA

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
Supported in part by Corning

4:00 p.m. – 5:30 p.m.
Concurrent Sessions


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 E. Gallagher, MBA, Vice President, Strategic Affairs, Teligent, Inc.

4:30 p.m. – 5:00 p.m.
Remediation of Aging Facilities and Equipment
Ronald A. Berk, Chief Technology Officer, Hyde Engineering + Consulting

5:00 p.m. – 5:30 p.m.
Panel Discussion with Presenters and Additional Participants
Ileana Barreto-Pettit, RN, MPH, Captain, U.S. Public Health Service, Drug National Expert, ORA, FDA
Anthony F. Lorenzo, Lead Consumer Safety Officer, CBER, FDA
John Lynch, MSc, MPSI, Director of Compliance, Health Products Regulatory Authority


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. A company will describe its journey after entering into a consent decree and its acquisition and remediation of the facility. The road to remediation has required systematic improvements in quality culture and quality systems. 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.
Anatomy of a Consent Decree
David L. Chesney, Principal and General Manager, DL Chesney Consulting, LLC

4:15 p.m. – 5:00 p.m.
Lessons Learned While Successfully Navigating a Consent Decree
Brandon Varnau, Head of Quality Operations Biologics Platform, Global Quality, Sanofi

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


C2: CMO Oversight: Challenges and Opportunities
Moderator: Tim G. Kilroy, PhD, Director, Global Quality Audits, Bristol-Myers Squibb

This session will explore CMO relationships 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. – 4:20 p.m.
Regulatory Perspective on CMO Oversight
Brooke K. Higgins, MS, Senior Policy Advisor, CDER, FDA

4:20 p.m. – 4:40 p.m.
An Industry Perspective on End-to-End CMO Oversight
Mary Collins, PhD, Executive Director, Quality, External Manufacturing, Bristol-Myers Squibb

4:40 p.m. – 5:00 p.m.
Collaborative Manufacturing Partnerships: The CMO Perspective
Natasha Rivas, Director, Quality Assurance and Quality Control, Vetter Development Services USA, Inc.

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

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

IG4: Environmental Monitoring/Microbiology & Quality Risk Management

In December 2017 the consultation period for revised Annex 1 draft was initiated for public comment. This document carries new requirements for aseptic processing and increases requirements for application of Quality Risk Management to sterile and aseptic processing. Many companies in the healthcare and pharmaceutical industry have collaborated to provide a single set of responses/comments to the Annex 1 revision committee. This collaboration was one of the most involved undertaking in the history of our industry. This session will share how this interactive process had evolved and what will be the next steps for various companies in this joint process and how to effectively apply Quality Risk Management to meet the requirements of the draft Annex.

IG5: Facilities and Engineering

The Facilities and Engineering Interest Group can cover many specific technical interests within the industry as they relate to Manufacturing Facilities and Engineering capabilities. There has been a tremendous amount of discussion around Aging Facilities the past couple of years, so for this meeting, we will continue a look at innovative solutions.

Our group is also working on two technical Points-to-Consider (PtC) documents related to Isolator Technology and VHP impact to process.  We will provide a look into the main concepts that are covered within and discuss some of the “hottest areas” of consideration.

IG6: Management of Outsourced Operations

RiskBased Oversight on Outsourced Operations

IG7: Packaging Science & Visual Inspection

This session will provide a brief update on general regulatory and pharmacopeial activities related to visual inspection and the packaging of sterile injectable products. It will provide a focus on the topic of the recently published proposed changes to Annex 1 and evolving technologies to assure container integrity. Brief presentations will be given followed by a moderated discussion of the use of these technologies and challenges and opportunities with their implementation.

IG8: Quality Systems

FDA Metrics Guidance Documents

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

Conference Registration | September 24-26, 2018


By July 30, 2018

After July 30, 2018


By July 30, 2018

After July 30, 2018

Young Professional Member


By July 30, 2018

After July 30, 2018

Government/Health Authority† 


By July 30, 2018

After July 30, 2018


By July 30, 2018

After July 30, 2018



By July 30, 2018

After July 30, 2018


By July 30, 2018

After July 30, 2018



By July 30, 2018

After July 30, 2018


By July 30, 2018

After July 30, 2018

One Day Only Fee

Monday, September 24 | Tuesday, September 25

PDA Member


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 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 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: Tape Recordings are prohibited at all PDA Conferences.

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

Single: $317.00, plus applicable taxes.

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. All cancellations must be received by 11:59 p.m., 3 days before arrival to avoid a penalty of one night's room and tax.


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.


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.

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

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

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