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12th Annual PDA Global Conference on Pharmaceutical Microbiology

Solving Microbiological Challenges and Sustaining Success through a Culture of Collaboration
Oct 16 - Oct 18, 2017 |
Oct 18, 2017 |
Bethesda North Marriott Hotel & Conference Center | Bethesda, MD
  • Conference
  • Western Hemisphere Events
Exhibition: October 16-17
Post-Workshop: October 18-19
Courses: October 19-20
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The 12th Annual PDA Global Conference on Pharmaceutical Microbiology is designed to meet the unique needs of pharmaceutical microbiologists and interdisciplinary scientists involved in manufacturing and regulating the pharmaceutical industry. It also provides excellent opportunities to network, interact, and share with and learn from industry experts and professionals from around the world.

This “best in class” Conference will feature an exciting agenda that encompasses a wide variety of issues pharmaceutical microbiologists face and work in partnership to solve daily. A theme of collaboration is woven throughout the Conference, focusing on how we work together to solve highly complex problems and develop novel, compliant, and robust solutions to ensure products are of the highest quality for patients. The “Ask the Experts” interactive session returns by popular demand!

Hear presentations at concurrent sessions from global regulatory and industry experts who will share recent case studies and current trends in the field of pharmaceutical microbiology. Hot topics include:

 

  • Quality Management for the Microbiology Laboratory
  • Updates from USP
  • Innovation in Pharmaceutical Microbiology
  • Data Integrity – Current Regulatory Perspective
  • Manufacturing Challenges – The Future of Biotech

In addition, PDA will host an exhibition of leading bio/pharmaceutical companies who will showcase new technologies and trends for pharmaceutical microbiology strategies. And don’t miss the poster presentations highlighting the latest research and developments in this exciting field! Lunch, refreshment breaks, and the Networking Reception will provide a relaxed environment to view posters, visit vendors, and interact with others to discuss topics from the day’s presentations.

Attend this Conference for the unique opportunity to contribute to future advancements in pharmaceutical microbiology.

Contact

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

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

Exhibition Inquiries
David Hall
Vice President, Sales 
Tel: +1 (240) 688- 4405
Email: hall@pda.org

Course Inquiries
Stephanie Ko
Senior Manager, Lecture Education 
Tel: +1 (301) 656-5900 ext. 151
Email: ko@pda.org

Monday, October 16

7:00 a.m. – 5:30 p.m.
Registration Open

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

8:15 a.m. – 8:30 a.m.
Welcome and Opening Remarks from Conference Co-Chair
Vinayak B. Pawar, PhD,
Senior Review Microbiologist, CDER, FDA

8:30 a.m. – 9:30 a.m.
P1: Opening Plenary Session
Moderator: Vinayak B. Pawar, PhD, Senior Review Microbiologist, CDER, FDA

Session Description: After achieving a dramatic triumph over infection in the 20th century with the introduction of antibacterial chemotherapy, the threat of bacterial diseases has resurged with the rise of antibacterial resistance. The Centers for Disease Control and Prevention (CDC) estimate that in the United States, more than two million people are sickened every year with antibiotic-resistant infections, with at least 23,000 dying as a result. The history and contributing factors to the rising trend of antibacterial resistance in the United States will be discussed, as well as recent successes and challenges in the development of novel antibacterial drugs. Efforts to facilitate the development of antibacterial drugs for serious or life-threatening illnesses will be highlighted, including new approaches to the design of clinical trials.

8:30 a.m. – 9:00 a.m.
The Challenge of Antibacterial Resistance: Learned Lessons and New Directions
Edward A. Weinstein, MD, PhD, Medical Officer, CDER, FDA

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

9:15 a.m. – 7:00 p.m. 
Exhibit Hall Open

9:30 a.m. – 10:15 a.m.
Refreshment Break and Poster Presentations in Exhibit Area

10:15 a.m. – 12:15 p.m.
Concurrent Sessions

A1: Microbial Control
Moderator: Edward Tidswell, PhD, Executive Director, Sterile Quality Assurance, Merck & Co./Merck Sharp & Dohme

Session Description: Bioburden and microbial contamination represent, and will continue to represent, significant challenges to the controlled manufacture of sterile, non-sterile drugs and devices. Successful control assuring the requisite end product microbial quality attributes must be commensurate with the different fundamental challenges bioburden and adventitious microbial contamination represent. This session will share strategies and practical tools as well as techniques in microbial control.

10:15 a.m. – 10:45 a.m.
Case Study of Environmental Mold Isolation in a Controlled Manufacturing Facility
Leslie Falco, Quality Assurance Microbial Control Lead, Pfizer Inc.

10:45 a.m. – 11:15 a.m.
Case Studies on Microbial Contamination: Benefit of a Cross-Functional Team Investigation
Walid El Azab, Ind. Ph., Manager, Technical Services, Life Sciences Formulated Chemistries, STERIS Corporation

11:15 a.m. – 11:45 a.m.
Fungal Spore Excursions in Cleanrooms: Case Studies
Jim Polarine Jr., MA, Senior Technical Service Manager, STERIS Corporation

11:45 a.m. – 12:15 p.m.
Questions and Answers/Discussion

B1: Non-Sterile
Moderator: Eric J. Ward, MBA, Quality Assurance Director, Boston Analytical, Inc.

Session Description: Manufacture of non-sterile products presents a very different set of challenges for the microbiology laboratory. These groups of products include a wide range of types and dosage forms, each with its own considerations. Control of the entire process, from raw materials to finished product, and the production area, is necessary to ensure that the conditions are appropriate for the intended application. As such, proper risk management is an essential component of these systems to provide thorough understanding of the system, the associated risks and proper controls. This session will delve into current regulatory expectations and trends, evaluation of incoming materials and environmental control as a part of the overall production system for non-sterile products.

10:15 a.m. – 10:45 a.m.
Microbial Impact Assessment
Kim Bowers, Quality Control Manager Environmental Monitoring/Microbiology, Shire

10:45 a.m. – 11:15 a.m.
Contamination Control in Non-Sterile Manufacturing
Patricia V. Mills Davis, MSc, Senior Manager, Microbiology Lab, Johnson & Johnson Consumer Inc.

11:15 a.m. – 11:45 a.m.
Taming the Microbial Zoo: FDA’s Perspectives on Non-sterile Drug Products
Erika A. Pfeiler, PhD, Microbiologist, CDER, FDA

11:45 a.m. – 12:15 p.m.
Questions and Answers/Discussion

12:15 p.m. – 1:30 p.m.
Exhibitor Roundtable Luncheon
Exhibitors will be seated at designated tables and will be available for informal discussion with attendees. Exhibit Hall will be closed during this time.

1:30 p.m. – 3:30 p.m.
Concurrent Sessions

A2: Combination Products
Moderator: Vinayak B. Pawar, PhD, Senior Review Microbiologist, CDER, FDA

Session Description: The pharmaceutical industry faces many manufacturing challenges as a wide spectrum of regulated treatments are now identified as combination products (e.g., patches, pumps, inhalers, nasal vaccines, targeted nanoparticles, syringes. and other delivery methods). Attendees will hear from the industry representative about combination product delivery system design (e.g., adequate cleanroom, support utilities, and equipment for manufacturing combination components) and manufacturing logistics such as continuous manufacturing applications and flexible facility designs. Regulatory speakers will discuss strategies for demonstrating compliance with cGMP requirement, whether for each of the constituent parts or for the combination product as a whole, with case studies related to current combination product initiatives and updates.

1:30 p.m. – 2:00 p.m.
Manufacturing Challenges
Susan Neadle, MS, Head, Combination Products Center of Excellence and Senior Director, Design-to-Value and Product Quality Management, Johnson & Johnson Janssen Pharmaceuticals

2:00 p.m. – 2:30 p.m.
Regulatory Challenges and Requirements for Combination Products: Current and Future
Melissa B. Burns, MS, Policy Advisor, OC, FDA

2:30 p.m. – 3:00 p.m.
Current Combination Product Initiatives and Updates: Case Studies
Steven B. Hertz, MS, Consumer Safety Officer, CDER, FDA

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

B2: Environmental Monitoring
Moderator: Marsha Steed (Hardiman), Senior Consultant, Valsource, LLC

Session Description: Environmental monitoring (EM) plays a critical role in our companies for all manufacturing types including non-sterile, low bioburden, medical devices, and aseptic processing. The industry is inundated with guidance about EM for aseptic processing operations, but there is a lack of guidance when it comes to low bioburden processes. This session will include an overview on a new PDA technical report which will give guidance for low bioburden EM. It will cover EM trending advantages when using contamination recovery rates to understand your results. A look into single incubation with rapid technology will also be shown with a case study example.

1:30 p.m. – 2:00 p.m.
Using Contamination Rates for Environmental Monitoring Trending
Paula Peacos, MS, Associate Director of Microbiology, Global Pharmaceutical Quality, Bristol-Myers Squibb

2:00 p.m. – 2:30 p.m.
Demonstrating Non-Inferiority for a Rapid, Automated Environmental Monitoring Technology Using a Single-Tiered Incubation Scheme
Laure Singer, Senior Associate, Quality Assurance, Pfizer Inc.

2:30 p.m. – 3:00 p.m.
Low Bioburden Environmental Monitoring: PDA Technical Report Development Update
Dona B. Reber, MEd, Technical Report Team Member and Co-Author of Technical Report No. 13 (Revised): Fundamentals of an Environmental Monitoring Program

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

3:30 p.m. – 4:15 p.m.
Refreshment Break and Poster Presentations in Exhibit Hall

4:15 p.m. – 5:45 p.m.
P2: Emerging Leaders
Moderator: Michael J. Miller, PhD, President, Microbiology Consultants, LLC

Session Description: Solving problems in the microbiology laboratory often requires collaboration between many individuals and across multiple departments. In addition, laboratory microbiologists often have to work across lines of responsibilities to ensure that projects are completed with involvement from all impacted areas. This session will include three case studies of problem resolution or project implementation with teams of individuals from the front line of the microbiology laboratory.

4:15 p.m. – 4:35 p.m.
Getting Your Product from Fill Line to Clinic (with a Little Help from your Friendly Neighborhood Microbiologist)
Carly Krystopik, Associate Research Scientist II, Bristol-Myers Squibb  

4:35 p.m. – 4:55 p.m.
You Gotta Know When to Hold ‘Em: Microbial Challenge Testing and In-use Hold Times for Non-preserved, Sterile, Single-use Products
Sarah Weiser, MS, Formulation Scientist, Pfizer Inc.  

4:55 p.m. – 5:15 p.m.
How Very Sterile This Johnny Is: The Conundrum of Sterility Testing a Terminally-Sterilized Biodegradable Implant
Melissa Gulmezian-Sefer, PhD,
Senior Scientist, SMPD Microbiology, Allergan Inc.

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

5:45 p.m. – 7:00 p.m.
Networking Reception in Exhibit Area

Tuesday, October 17

7:00 a.m. – 4:30 p.m.
Registration Open

7:00 a.m. – 8:15 a.m.
Continental Breakfast

7:00 a.m. – 8:00 a.m.
Breakfast Roundtable
Moderator: Marsha Steed (Hardiman), Senior Consultant, ValSource, LLC

Session Description: The breakfast round table sessions will capture the conference theme of collaboration by bringing together attendees to address some hot Microbiology topics. Some of these topics may not yet have consensus in the industry so further discussion is warranted. These will be presented in an innovative point/counter-point format, with experts presenting advantages and disadvantages, and risks and benefits of key topics such as: data integrity in the Microbiology lab (multiple analysts reads on plates), incubation schemes for EM, and reaction to microbiological excursions in the critical Grade A environment. The sessions will include small group break out discussions on these and other topics to determine comments and collect feedback for the health authorities.

Facilitators:
Amy McDaniel, PhD,
Director, Quality Assurance Operations, Pfizer Inc.
Kim Sobien, Principal Sterility Assurance Engineer, PETNET Solutions | A Siemens Company 
Eric J. Ward, MBA, Quality Assurance Director, Boston Analytical, Inc.

8:15 a.m. – 9:15 a.m.
P3: Patient Perspective
Moderator: Kim Sobien, Principal Sterility Assurance Engineer, PETNET Solutions | A Siemens Company

Session Description: As a reminder of the importance of our work as pharmaceutical Microbiologists, we will hear directly from a patient, who is also an industry microbiologist, who has benefited from the pharmaceutical and medical device products that our companies manufacture. No one ever plans on becoming ill; but when it happens to someone, that patient relies on the quality, safety, efficacy, and sterility of the products we manufacture in our jobs to aid in their recovery. This patient perspective talk will remind us why we do what we do for a living and will bring together the patient benefits received as a result of our good work.

8:15 a.m. – 9:00 a.m.
When the Microbiologist Becomes the Patient
Marsha Steed (Hardiman), Senior Consultant, ValSource, LLC

9:00 a.m. – 9:15 a.m.
Questions and Answers/Discussion


9:00 a.m. – 4:15 p.m.
Exhibit Hall Open

9:15 a.m. – 10:00 a.m.
Refreshment Break, Poster Presentations, and Passport Raffle in Exhibit Hall

10:00 a.m. – 12:00 p.m.
Concurrent Sessions

A3: Quality Management for the Lab
Moderator: MaryEllen E. Usarzewicz, MS, Parenteral Manufacturing Support Lead, Analytical & Bioanalytical Operations, Microbiology, Bristol-Myers Squibb

Session Description: In alignment with the Conference theme, this session will focus on the criticality of collaboration in a regulated microbiology environment. Microbiologists are called upon to participate in excursion investigations and to provide guidance proactively. Ensuring that microbiologists can educate and train colleagues within their organizations and help to assure that their input is understood is crucial. This session will provide information about a risk-based approach to assessing environmental monitoring and critical utilities excursions, insight into the collaborative efforts of FDA investigators working together to assess quality for our patients, as well as a case study on how one organization implemented a shop floor program driving collaboration between microbiology quality control, operations, and quality assurance.

10:00 a.m. – 10:30 a.m.
Aseptic Observation Program: A Shop Floor Program that Engages Quality and Operations to Assure Good Aseptic Technique
Lisa Sykes-Winstead, MBA, Director of Quality Operations, Sterile Network Lead, Merck & Co./Merck Sharp & Dohme

10:30 a.m. – 11:00 a.m.
Risk-Based Microbial Assessment Tool (R-MAT): A Novel Approach to Assessing Environmental and Critical Utilities Excursions
Amanda Bishop McFarland, Consultant, ValSource, LLC

11:00 a.m. – 11:30 a.m.
Collaborative Inspections: How Many Teams of U.S. FDA Investigators and Microbiologists Work Together to Evaluate Drug Manufacturing Quality
U.S. FDA ORA Representative Invited

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

B3: Innovation in Pharmaceutical Microbiology
Moderator: Amy McDaniel, PhD, Director, Quality Assurance Operations, Pfizer Inc.

Session Description: This session will focus on innovations for the modern microbiology laboratory, with an emphasis on advancing the science of detecting microorganisms and the manner in which we analyze the data. Participants will learn about the need for online water bioburden systems and how a number of companies have established strategies for validating new water monitoring technologies. The results from PQ comparative studies will also be shared. We will also hear a case study on applying statistical analyses on microbiological data to support claims of equivalence and non-inferiority when comparing alternative methods to compendial methods. The presentation will walk through the statistical models in an easy-to-understand format followed by case studies on how to apply the models using actual data. The session will end with a regulatory overview of the state of rapid sterility testing by one of FDA’s leading experts on alternative microbiological methods. The current need for rapid sterility testing, regulatory enablers and examples of successful validation case studies will be discussed.

10:00 a.m. – 10:30 a.m.
Towards a New Paradigm for Compendial Sterility Testing
Anthony M. Cundell, PhD, Consulting Microbiologist, Microbiological Consulting, LLC  

10:30 a.m. – 11:00 a.m.
Case Studies on Selecting Statistical Approaches for the Validation of Alternative and Rapid Microbiological Methods
Michael J. Miller, PhD,
President, Microbiology Consultants, LLC

11:00 a.m. – 11:30 a. m.
Rapid Sterility Tests
Bryan S. Riley, PhD, Branch Chief (Acting), Division of Microbiology Assessment Branch II, CDER, FDA

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 Hall Closed. A listing of local restaurants is available at the PDA registration desk

1:30 p.m. – 3:30 p.m.
Concurrent Sessions

A4: Biotechnology
Moderator: Walid El Azab, Ind. Ph., Manager, Technical Services, Life Sciences Formulated Chemistries, STERIS Corporation

Session Description: Recent regulatory updates and technological and manufacturing developments are significantly influencing the biopharmaceutical industry. The biopharmaceutical industry is facing pressure to continuously challenge and improve their manufacturing processes to achieve regulatory compliance and high quality product. In addition, it is also expected to implement new technology to improve microbial control and faster response to avoid drug shortage. The goal of this session is to share different industry perspectives on how introduction of new technology, robust aseptic training, effective root cause investigation,  and microbial control will support lean processes, faster lead-time, improved return on investment, and regulatory compliance.

1:30 p.m. – 2:00 p.m.
It Takes Two to Take Control (Microbial Control, That Is)!
Ruth Varden, MSc, Director, Quality, Alexion Pharmaceuticals, Inc.
Jane Wyatt, MSc, Director, Quality Control Ireland, Alexion Pharmaceuticals, Inc.

2:00 p.m. – 2:30 p.m.
The Use of Environmental Monitoring Recovery Rates in Support of Bulk Biologic Manufacturing 
Jeanne Mateffy,
Director Quality Services, Microbiology, Amgen Inc. 

2:30 p.m. – 3:00 p.m.
A Risk-Based Approach for an Aseptic Manipulation and Intervention Program
Frederic B. Ayers, 
Consultant Scientist - Sterility Assurance Technology, Eli Lilly and Company

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

B4: Data Integrity
Moderator: Julie Barlasov, MBA, Associate Director, Sterile and Microbiology Quality Assurance Center of Excellence, Merck & Co./Merck Sharp & Dohme

Session Description: Data integrity is one of the hottest topics in the pharmaceutical industry, including in the microbiology world. We encounter daily questions like: how do we record data, how do we assure that information is accurate and contemporaneous, what is the data life cycle, how do we stay in compliance, and what are regulators looking for? This session will examine the regulatory perspective, holistic management governance, data governance initiatives, how to prevent and detect data integrity risks, and case studies.

1:30 p.m. – 2:00 p.m.
Current Regulatory Perspectives on Data Integrity
Paula Katz, JD, Director, Manufacturing Quality Guidance and Policy, CDER, FDA
 
2:00 p.m. – 2:30 p.m.
Combating Human Error
Monica Cahilly, MS, President/Consultant, Green Mountain Quality Assurance, LLC

2:30 p.m. – 3:00 p.m.
Auditing Techniques to Reveal Data Integrity Problems in Microbiology Laboratories 
Dennis E. Guilfoyle, PhD, MS,
Senior Director, Microbiology & Analytical Regulatory Compliance, Johnson & Johnson Regulatory Compliance 

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

3:30 p.m. – 4:15 p.m.
Refreshment Break, Poster Presentations, and Passport Raffle in Exhibit Hall

4:15 p.m. – 6:00 p.m.
P4: FDA Update on Human Drug Compounding: Regulatory Policy and Drug Quality
Moderator: John W. Metcalfe, PhD, Quality Assessment Lead, Division of Microbiology Assessment, Office of Process and Facilities/Office of Pharmaceutical Quality, CDER, FDA

Session Description: During this session, FDA will provide an update on the Agency’s regulation and oversight of human drug compounding since passage of the 2013 Drug Quality and Security Act (DQSA), which established a new category of drug compounders called outsourcing facilities. FDA speakers will provide an overview of the Agency’s compounding oversight program and describe relevant policies. Participants will learn about FDA’s inspectional program for outsourcing facilities; quality standards, including current good manufacturing practice requirements, and insanitary conditions, applicable to outsourcing facilities; and guidance documents and regulations that pertain to outsourcing facilities. The session is targeted to participants from all segments of the pharmaceutical industry, and is especially applicable to those working in the newly established outsourcing facility arena.   

4:15 p.m. – 4:35 p.m.
Overview of FDA’s Compounding Program
Julie Dohm, PhD, JD, Agency Lead on Compounding and Senior Scientific Advisor for Compounding, CDER, FDA

4:35 p.m. – 4:55 p.m.
FDA Policies Relevant to Compounding Quality
Sara Rothman, MPH, Senior Policy Advisor, Office of Unapproved Drugs and Labeling Compliance, Office of Compliance, CDER, FDA

4:55 p.m. – 5:15 p.m.
FDA Inspections of Outsourcing Facilities
Justine Tomasso, MBS, Consumer Safety Officer, Pharmaceutical Quality Programs Branch, Division of Pharmaceutical Quality Programs/Office of Pharmaceutical Quality Operations, ORA, FDA

5:15 p.m. – 5:45 p.m.
Understanding CGMP Requirements and Insanitary Conditions
Ian F. Deveau, PhD, Chief, Global Compliance Branch 1, Division of Drug Quality I, Office of Manufacturing Quality, Office of Compliance, CDER, FDA

5:45 p.m. – 6:00 p.m.A
Questions and Answers/Discussion

Wednesday, October 18

7:00 a.m. – 12:30 p.m.
Registration Open

7:00 a.m. – 8:15 a.m.
Continental Breakfast

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

Breakfast Roundtable Report Out
Moderator: Marsha Steed (Hardiman), Senior Consultant, Valsource, LLC

Session Description: This roundtable will include a report out and full audience discussions on the results of day 1 findings from the various small groups. Collaboration will help make us all more informed on how to tackle these issues back in our own companies.

Facilitators:
Amy McDaniel, PhD, Director, Quality Assurance Operations, Pfizer Inc.
Kim Sobien, Principal Sterility Assurance Engineer, PETNET Solutions | A Siemens Company 
Eric J. Ward, MBA, Quality Assurance Director, Boston Analytical, Inc.

Microbiology/Environmental Monitoring Interest Group
Moderator: Julie Barlasov, MBA, Associate Director, Sterile and Microbiology Quality Assurance Center of Excellence, Merck & Co./Merck Sharp & Dohme

Session Description: The Microbiology/Environmental Monitoring Interest Group addresses topics in pharmaceutical microbiology, rapid microbiology, environmental monitoring, and compendial issues.

8:15 a.m. – 9:30 a.m.
P5: USP Updates
Moderator: Radhakrishna Tirumalai, Principal Scientific Liaison, U.S. Pharmacopeial Convention

Session Description: Compatible with its overall mission, the role of the USP in microbiology and sterility assurance is to develop public standards pertaining to microbiology that, along with other requirements, ensure the consistent quality of products. This session will provide an overview on current and proposed activities of the USP General Chapters-Microbiology Expert Committee, with emphasis on revisions to existing chapters and new chapter proposals.

8:15 a.m. – 8:40 a.m.
Current Activities of the USP Microbiology Expert Committee        
David Hussong, PhD, Microbiology and Regulatory Consultant, ValSource, LLC

8:40 a.m. – 9:05 a.m.
Proposed Revisions to USP <1211> and <1222>
Edward Tidswell, PhD, Executive Director, Sterile Quality Assurance, Merck & Co./Merck Sharp & Dohme

9:05 a.m. – 9:30 a.m.
Questions and Answers/Discussion

9:40 a.m. – 10:40 a.m.
P6: The Mutual Reliance Initiative: A New Path for Pharmaceutical Inspections in Europe and Beyond
Moderator: CAPT Sharon K. Thoma, PharmD, National Expert of Pharmaceuticals, United States Public Health Service, ORA, FDA

Session Description: Mutual Reliance Initiative is a new path for Mutual Recognition Agreements between two or more countries to recognize a specific process or procedure of the other country. The intent is to create an expanded inspectorate, one where investigators and inspectors from FDA and trusted partners, such as those in the European Union and beyond, would work together, rely on each other’s inspections, avoid duplicating inspections, and conduct more inspections in areas where the increase in drug manufacturing has greatly increased. The benefit of Mutual Recognition is in strengthening the use of each other’s drug inspection expertise and resources which will result in greater efficiencies for both regulatory systems and provide a more practical means to oversee the large number of drug manufacturing facilities outside of the U.S. and EU.

9:40 a.m. – 10:10 a.m.
FDA's 2017 Mutual Reliance Initiative
Susan F. Laska, Senior Advisor for Medical Products, ORA, FDA

10:10 a.m. – 10:40 a.m.
Questions and Answers/Discussion

10:40 a.m. – 11:00 a.m.
Refreshment Break

11:00 a.m. – 12:30 p.m.
P7: Ask the Regulators
Moderators: Kim Sobien, Principal Sterility Assurance Engineer, PETNET Solutions | A Siemens Company and John W. Metcalfe, PhD, Quality Assessment Lead, Division of Microbiology Assessment, Office of Process and Facilities/Office of Pharmaceutical Quality, CDER, FDA

Session Description: In the "Ask the Regulators" session, attendees can interact directly with members of regulatory agencies to pose questions and get answers about pressing microbiology issues. This session will provide attendees with a unique opportunity to engage several regulatory speakers in further discussions regarding regulations, trends, solutions, and best demonstrated practices.

Panelists
U.S. FDA ORA Representative Invited
U.S. FDA CDRH Representative Invited

Julie Dohm, PhD, JD, Agency Lead on Compounding and Senior Scientific Advisor for Compounding, CDER, FDA
Lynne A. Ensor, PhD, Director, Division of Microbiology Assessment, CDER, FDA
Laurie P. Norwood, Deputy Director, Office of Compliance and Biologics Quality, CBER, FDA

12:30 p.m.
Closing Remarks from the Conference Co-Chair
Kim Sobien, Principal Sterility Assurance Engineer, PETNET Solutions | A Siemens Company


Conference and Workshop Registration | October 16-19

Member

Before August 4, 2017
$3,340

August 4 - September 5, 2017
$3,790

After September 5, 2017
$4,240

Non-member

Before August 4, 2017
$3,819

August 4 - September 5, 2017
$4,269

After September 5, 2017
$4,719


Conference Registration | October 16-18

Member

Before August 4, 2017
$1,995

August 4 - September 5, 2017
$2,395

After September 5, 2017
$2,595

Non-member

Before August 4, 2017
$2,274

August 4 - September 5, 2017
$2,674

After September 5, 2017
$2,874


Government/Health Authority/Academic

Member

Before August 4, 2017
$700

August 4 - September 5, 2017
$700

After September 5, 2017
$700

Non-member*

Before August 4, 2017
$800

August 4 - September 5, 2017
$800

After September 5, 2017
$800


Student

Member

Before August 4, 2017
$280

August 4 - September 5, 2017
$280

After September 5, 2017
$280

Non-member*

Before August 4, 2017
$310

August 4 - September 5, 2017
$310

After September 5, 2017
$310

All prices in US dollars.

* For this member type or discounted rate, online registration is not available and 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 workshop and course.

Group Registration Discount

Register 4 people from the same organization as a group (at the same time) for the Conference or Workshop and receive the 5th 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 August 17, 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 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). Refunds for Full Conference, Workshops and Events: If your written request in received on or before August 17, 2017, you will receive a full refund minus a $200 processing fee. After that time, no refunds or credit requests will be approved. Onsite registrants are not guaranteed to receive Conference materials until all advanced registered attendees receive them. PDA reserves the right to modify the material or speakers/instructors without notice or to cancel an event. If an event must be canceled, registrants will be notified by PDA in writing as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancelation. For more details, contact PDA at info@pda.org or +1 (301) 656-5900.

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

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

Bethesda North Marriott HotelBethesda North Marriott Hotel & Conference Center
5701 Marinelli Rd
North Bethesda, MD 20852
Phone: +1 (301) 822-9200

Important Note: The PDA Block is now closed, however guest rooms may still be available. Please call the hotel directly at the number listed above.

Hotel Accommodations

To make reservations at the Marriott Bethesda North Hotel and Conference Center, please call the Hotel at +1 (301) 822-9200 and reference PDA's 12th Annual Global Conference on Pharmaceutical Microbiology & Education Courses 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 6:00 p.m. on the date of arrival otherwise specified on your reservation information.

Amenities

The Marriott Bethesda North Hotel & Conference Center is adjacent to the White Flint METRO Station on the RED line offering easy access to Rockville, Bethesda, Washington D.C. and Northern Virginia. All 220 guest rooms and suites provide high-speed Internet, upgraded Marriott Revive bedding, coffee makers, hair dryers, iron, and an ironing board. This hotel has a smoke-free policy and no pets are allowed.

Travel

Area Airports
Reagan National Airport (DCA) is approximately 20 miles from the hotel and all major carriers service this airport. Two other airports in the vicinity are both serviced by all major carriers: Dulles International, 24 miles away, and Baltimore-Washington International, 34 miles away.

Ground Transportation
Taxi fares from DCA are approximately $55 one way, not including tip, and will take about 30 minutes. One way taxi fares from Dulles is approximately $55 and from BWI about $75.

Driving
Bethesda North Marriott is located on Marinelli Road off of Rockville Pike in Rockville.

Metro
The Bethesda North Marriott is located on the RED line at the White Flint Station.

Hotel Parking
$15 Self Parking

Network, Collect Intelligence and Forge Key Relationships

The PDA 12th Annual Global Conference on Pharmaceutical Microbiology  is one of PDA’s Signature Events, and one of our most popular meetings as well, typically attracting more than 300 Conference attendees. With multiple networking breaks, exhibitor roundtable luncheon, and reception, exhibitors have ample time to connect with your desired audience of industry leaders, strengthen business relationships, and create new sales leads. The comprehensive booth or tabletop exhibit package includes one full conference registration and one exhibit only badge, company listing on the Conference website and in the on site exhibit guide, six foot skirted table, chair, trash can, ID sign, on site personal assistance, and  list of pre-registered attendees distributed at the meeting. As an exhibitor you will gain exclusive access to hundreds of highly qualified biopharmaceutical professionals from microbiology, manufacturing, laboratories, compliance, quality, research and development, engineering, validation, regulatory affairs as well as executives, managers, scientists, technicians and analysts.

Increase Brand Recognition

Become a sponsor at the conference to strengthen your brand image, increase your visibility, drive traffic to your booth, and align your company with industry leading minds and world class content. High profile sponsorships are available for lanyards, notepads, wireless internet service, audience response systems, tote bags, hotel keycards, mobile device charging stations, 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 at +1 (301) 656-5900 ext. 160; cell +1 (240) 688-4405; hall@pda.org or Alison Caballero at +1 (301) 656-5900 ext. 135; caballero@pda.org.

Register Now
https://store.pda.org/Meetings/Login.aspx?ID=3598

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