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2019 PDA Rapid Microbiological Methods Workshop

Oct 23 - Oct 24, 2019
Rockville, MD

  • Conference
  • Workshop
  • The Americas
Program Highlights

Don't miss out on this incredible Workshop - live streaming is available! Enjoy a collaborative experience, virtually connecting with others across the globe.

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The validation, approval, and implementation of rapid and alternative microbiological methods has been steadily increasing within the pharmaceutical, biopharmaceutical, compounding pharmacy, and advanced therapy medicinal products (ATMP, gene and cell therapy) industries. Novel drug products and innovative manufacturing processes now require modern strategies for demonstrating microbiological control.

The 2019 PDA Rapid Microbiological Methods Workshop will provide attendees with an overview of the current landscape for rapid method validation strategies, implementation opportunities, and global regulatory approval processes. Presentations by subject matter experts and global regulators will focus on real-world practices for rapid and alternative microbiology testing of in-process samples and sterile and nonsterile finished product.

Major topics to be covered will include:

  • Regulatory expectations for validation and implementation
  • The impact of the revised Annex 1 on the use of rapid methods
  • How to overcome roadblocks and perceived issues related to the implementation of alternative microbiology assays and instrumentation
  • Recent case studies by industry end users on validation, regulatory submissions, and implementation
  • The detection of microorganisms relevant to manufacturing processes, environmental monitoring, and facility control, including Mycoplasma
  • Current status of compendial chapter in support of rapid methods
  • New paradigms necessary for the acceptance of technologies not based on the colony-forming unit

This Workshop will present practical approaches to rapid microbiology testing that participants can use in daily work, laboratory, and manufacturing operations.


  • Day 1
  • Day 2
  • Wednesday, October 23

    12:00 p.m. – 5:30 p.m.
    Registration Open

    1:30 p.m. – 3:30 p.m.
    P1: Global Regulatory Overview of Challenges and Opportunities
    Moderator: Michael J. Miller, PhD, President, Microbiology Consultants, LLC

    The implementation of rapid microbiological methods has been gaining momentum across a number of industry sectors. Simultaneously, recent global regulatory policy updates and guidance documents have supported the use of rapid methods. This session will explore current regulatory framework for the validation, submission and utilization of rapid methods. Experts who have worked in this space from the FDA and EMA will share their experiences and provide additional guidance on how to satisfy regulatory expectations.

    1:30 p.m. – 1:45 p.m.
    Welcome and Opening Remarks from Workshop Co-Chairs
    Tony Cundell, PhD, Consulting Microbiologist, Microbiological Consulting, LLC
    Michael J. Miller, PhD, President, Microbiology Consultants, LLC

    1:45 p.m. – 2:15 p.m.
    U.S. FDA CDER & CBER Review Expectations 
    Erika A. Pfeiler, PhD, Supervisory Microbiologist, CDER, U.S. FDA
    CDR Simleen Kaur, MSc, Biologist, Team Lead, CBER, U.S. FDA
    CDR James L. Kenney, DSc, Chief, LMIVTS, CBER,U.S. FDA

    2:15 p.m. – 2:30 p.m.
    Alternative Microbiological Methods Used at Compounding Facilities 
    Haijing Hu, PhD, Senior Microbiologist, CDER, U.S. FDA

    2:30 p.m. – 3:00 p.m.
    Do the EU GMPs Require the Use of Rapid Microbiological Methods?
    Andrew D. Hopkins BSc, Hon PGDip, Director, Operation Quality QA Audit and Compliance, AbbVie Inc.

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

    3:15 p.m. – 7:00 p.m.
    Exhibit Area Open

    3:30 p.m. – 4:00 p.m.
    Refreshment Break in Exhibit Area

    4:00 p.m. – 5:45 p.m.
    P2: Regulatory Considerations for Validation and Real-Time Testing
    Moderator: Erika A. Pfeiler, PhD, Supervisory Microbiologist, CDER, U.S. FDA

    Real-time test results can lead to better decisions regarding the microbiological quality of a product.  In some cases, it may provide the only opportunity for testing.  In this session, we will explore this burgeoning sub-field of alternative testing methods.  This session will also direct participants to useful updates, examples, and resources associated with the updated Ph.Eur. 5.1.6.

    4:00 p.m. – 4:25 p.m.
    The Evolution Position of the USP Rapid Microbial Methods
    Tony Cundell, PhD, Consulting Microbiologist, Microbiological Consulting, LLC

    4:25 p.m. – 4:50 p.m.
    European Pharmacopoeia Chapter 5.1.6 “Alternative Methods for Control of Microbiological Quality”
    Sven M. Deutschmann, PhD, Head of Global ASAT Adventitious Agents Testing & Alternative Microbiological Methods
    Global Analytical Science & Technology (gASAT) Global QC, Roche Diagnostics GmbH

    4:50 p.m. – 5:15 p.m.
    Development of Rapid Microbiological Methods for the Pharmaceutical Sciences
    Yutaka Kikuchi, PhD, Professor, Chiba Prefectural University of Health Sciences

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

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

  • Thursday, October 24

    7:15 a.m. – 3:30 p.m.
    Registration Open

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

    8:30 a.m. – 10:00 a.m.
    P3: Rapid Microbial Methods Appropriate for Air and Water Monitoring and Cellular Therapy Sterility Testing
    Moderator: Tony Cundell, PhD, Consulting Microbiologist, Microbiological Consulting, LLC

    Two case histories are presented how two different organizations approached the selection, validation, regulatory approval, and implementation of the RMM to: 1) improve in-process control in their facility and 2) expedited the detection of microbial contamination in cell cultures. The speakers will highlight lessons learnt during this process.

    8:30 a.m. – 9:00 a.m.
    Bioflorescent Particle Counter-Based Real-Time Feedback and Control of Processing Conditions
    Frederic B. Ayers,
     Research Scientist, Eli Lilly and Company

    9:00 a.m. – 9:30 a.m.
    Validation Process for a Rapid Sterility Testing Method to Determine the Sterility of an Advanced Therapy Medicinal Product (ATMP)
    Andrew A. Finnerty, BSc, Grad. Dip, MBA, General Manager, Centre for Cell Manufacturing Ireland (CCMI) - REMEDI at NUIG Galway Ireland

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

    9:45 a.m. – 3:45 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.
    P4: Finish Product Testing of Sterile and Non-Sterile Products
    Moderator: Irving Ford MSc, Head of CAR-T QC Laboratories, Celgene, Biotechnology Company

    Due to increasing demands for expedited product shipments, lean manufacturing processes, and cost reduction efforts, the need for rapid methods for final product testing has become a necessity for expedited testing and product release. This need can be met with rapid microbiology methods. In this session, rapid microbiology methods that have been successfully validated and implemented for both sterile and non-sterile final product testing will be explored.

    10:45 a.m. – 11:15 a.m.
    Validation of ScanRDI for Release of Compounded Pharmaceutical Products 
    Anthony T. Grilli, MS, Owner, FOCUS Laboratories / Atlas Analytical Inc.

    11:15 a.m. – 11:45 a.m.
    Real-Time PCR Detection of Burkholderia cepacia in Pharmaceutical Products Contaminated with Low Levels of Bacterial Contamination
    Luis E. Jimenez, Sr., PhD,  Professor, Bergen Community College

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

    12:15 p.m. – 1:30 p.m.
    Network Lunch

    1:30 p.m. – 3:00 p.m.
    P5: Implementation of Rapid Methods for In-Process and Finished Product Testing
    Moderator: Michael J. Miller, PhD, President, Microbiology Consultants, LLC

    The use of rapid methods for in-process and finished product testing has a number of advantages over conventional testing, including faster times to result that can facilitate GMP decisions related to microbiological control. This session will explore the routine use of rapid Mycoplasma and automated, growth-based technologies and provide a framework for regulatory acceptance and approval for these alternative methods. 

    1:30 p.m. – 1:50 p.m.
    Rapid Mycoplasma Development and Validation Strategy to Obtain Regulatory Approval for MACI® Product Release Testing
    John Duguid, Senior Director, Research & Development, Vericel Corporation

    1:50 p.m. – 2:10 p.m.
    Automated Colony Counting at Biogen: TRP Microbiology Current State of Implementation and Vision
    Bill M. Carpenter, MS, Senior Manager, QC Microbiology, Biogen, Inc.

    2:10 p.m. – 2:30 p.m.
    Validation and Global Implementation of PCR-based Alternative Mycoplasma-Detection Assays
    Sven M. Deutschmann, PhD, Head of Global ASAT Adventitious Agents Testing & Alternative Microbiological Methods
    Global Analytical Science & Technology (gASAT) Global QC, Roche Diagnostics GmbH

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

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

    3:45 p.m. – 5:30 p.m.
    P6: Ask the Experts and Regulators
    Moderator: Irving Ford, MSc, Head of CAR-T QC Laboratories, Celgene, Biotechnology Company

    Have you ever wondered which method is correct for your application and/or will your chosen method be met with resistance from regulators?  Then, the session is for you!  Come and engage in an exciting panel discussion with key industry experts and representatives from various global regulatory agencies as we probe into the fascinating world of rapid microbiology methods and the many perceived and/or factual opportunities/challenges that they bring.  You are guaranteed to leave with an enhanced and renewed vigor for evaluating and implementing rapid microbiology methods.

    3:45 p.m. – 5:15 p.m.
    Panel Discussion
    Tony Cundell, PhD,
     Consulting Microbiologist, Microbiological Consulting, LLC
    Sven M. Deutschmann, PhD, Head of Global ASAT Adventitious Agents Testing & Alternative Microbiological Methods Global Analytical Science & Technology (gASAT) Global QC, Roche Diagnostics GmbH
    Andrew D. Hopkins, BSc, HonPGDip, Director, Operation Quality QA Audit and Compliance, AbbVie, Inc.
    CDR James L. Kenney, DSC, Chief, LMIVTS, CBER, U.S. FDA
    Michael J. Miller, PhD, President, Microbiology Consultants, LLC
    Erika A. Pfeiler, PhD, Supervisory Microbiologist, CDER, U.S. FDA

    5:15 p.m. – 5:30 p.m. 
    Closing Remarks and Final Wrap-Up from Workshop Co-Chairs
    Tony Cundell, PhD, Principal Consultant, Microbiological Consulting, LLC
    Michael J. Miller, PhD, President, Microbiology Consultants, LLC

Highlighted Speakers

Frederic B.  Ayers
Frederic B. Ayers
Eli Lilly and Company
Tony Cundell
Tony Cundell
Microbiological Consulting, LLC
Sven M. Deutschmann
Sven M. Deutschmann
Roche Diagnostics GmbH
John Duguid
John Duguid
Vericel Corporation
Irving Ford
Irving Ford
Celgene, Biotechnology Company
Yutaka Kikuchi
Yutaka Kikuchi
Chiba Prefectural University of Health Sciences
Michael J. Miller
Michael J. Miller
Microbiology Consultants, LLC
Erika Pfeiler
Erika Pfeiler

Additional Information

  • Learning Objectives

    Learning Objectives

    Upon completion of this Workshop, you will be able to:

    • Compare and contrast the benefits between alternative/RMM technologies and traditional microbiological methods
    • Explain the regulatory environment, current policies, and expectations for validation, submissions, and implementation from FDA, EMA, and other regulatory authorities
    • Apply industry best practices for validating these new technologies in order to demonstrate that the methods are acceptable for their intended use
  • Who Should Attend

    Who Should Attend

    • Departments: Microbiology, Compliance, Engineering, Manufacturing, QA/QC, CMC Documentation, Regulatory Affairs, Research and Development, Validation, QP
    • Level of Expertise: Senior Management, Scientists/Technicians
    • Job Function: Supervisor, Researcher, Analyst, Operative Personnel
  • Accreditation


    NOTE   Continuing education credits are not available for this event.

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Virtual Attendance

Can't make it to Rockville, MD in person?

Virtual attendance allows you to experience, from the comfort of your home or office, all the presentations from global regulatory and industry experts who will share recent case studies and current trends in the field of pharmaceutical microbiology. Interactive features in the live-stream player allow you to enjoy a collaborative experience that connects you with a community of practitioners from around the world.

Participate virtually at a discounted rate of $1,000!


PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Bethesda North Marriott Hotel & Conference Center

5701 Marinelli Rd
Rockville, MD
Phone: +1 (301) 822-9200

Bethesda North Marriott Hotel & Conference Center
  • Accommodations

    The PDA room block is currently full, however there may still be rooms available at the prevailing rate. Please contact the hotel directly at +1 (301) 822-9200 to secure your reservations. Check-in time is 4:00 p.m.; 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. (EDT) 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.

How to Get Here

By Air

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.

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.

By Car

Bethesda North Marriott is located at 5701 Marinelli Road, Rockville, MD 20852.

Hotel Parking
Hotel parking for registered guests: $17 daily
Conference Center day guests: $2.50 hourly, max of $30 per day.

Other Options

More information coming soon.


Registration Fees

Early Registration
Registration Type Price by August 9
Member $1,495
Non-member $1,695
Young Professional Member $748
Gov’t/Health Auth./Academic Member $700
Gov’t/Health Auth./Academic Non-member* $800
Student Member $280
Student Non-member* $310

Regular Registration
Registration Type Price after August 9
Member $1,695
Non-member $1,895
Young Professional Member $848
Gov’t/Health Auth./Academic Member $700
Gov’t/Health Auth./Academic Non-member* $800
Student Member $280
Student Non-member* $310

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

† You must be a member to receive this rate.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Group Registration Discount

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

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact [email protected] or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent 30 days before the event, no fee will be charged. After this period, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent 30 days before the event, a full refund will be given minus a $200 fee. After this period, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to [email protected]. Phone messages are not accepted.


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