Skip To The Main Content
2020RapidMicro-1988x680

2020 PDA Rapid Microbiological Methods Workshop

Oct 22 - Oct 23, 2020
Eastern Standard Time | Online
  • Virtual
  • Conference
  • Online
  • The Americas

Overview

As the pharmaceutical industry continues its fast-moving evolution, the focus on new technologies intensifies. The validation, approval, and implementation of rapid and alternative microbiological methods has also 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.

Attend the 2020 PDA Rapid Microbiological Methods Workshop virtually to gain meaningful insight and practical lessons learned from actual success stories on important issues currently facing the industry. Explore 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.

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

Agenda

  • Day 1
  • Day 2
  • Thursday, October 22

    10:00 a.m. – 11:45 a.m. | P1: Case Studies on Method Suitability and Validation
    Moderator: Erika A. Pfeiler, PhD, Supervisory Microbiologist, CDER, U.S. FDA

    We have all heard so much about the barriers to adopting rapid microbiological methods – technological issues, expense, regulatory compliance – so why should the microbiologists take on the hassle of advocating for them in their organizations? This session highlights the expanding usefulness of rapid methods to demonstrate microbiological quality for a variety of products. The speakers have each dealt with and overcome the barriers to adoption, worked towards successful implementation of a rapid method, and are here to share their experiences.

    10:00 a.m. – 10:15 a.m. | Welcome and Opening Remarks
    Amy McDaniel, Bristol Myers Squibb

    10:15 a.m. – 10:30 a.m. | What is Rapid Microbiological Methods and Why is it Important
    Michael J. Miller, PhD, President, Microbiology Consultants, LLC

    10:30 a.m. – 10:50 a.m. | Demonstrating Method Suitability for an ATP-bioluminescence Rapid Method for Egg-Based Vaccine Testing
    Stacey N. Ramsey, MS, SM(NRCM), Associate Product Manager, Charles River Laboratories

    10:50 a.m. – 11:10 a.m. | Evolution of an Automated Rapid Microbial Testing Technology for Industrial Applications, Adapting a Clinical Platform to Satisfy Industrial Requirements
    Lori L. Daane, PhD, Director of Scientific Affairs, bioMérieux, Inc.

    11:10 a.m. – 11:30 p.m. | Industry Representative Invited

    11:30 a.m. – 11:45 a.m. | Q&A

    11:45 a.m. – 12:30 p.m. | Exhibit Networking

    12:30 p.m. – 2:00 p.m. | P2: Expecting the Unexpected: Overcoming the Challenges of Rapid Testing
    Moderator: Andrew D. Hopkins, BSc Hon PGDip, Director, Operation Quality QA Audit and Compliance, AbbVie, Inc.

     

    12:30 p.m. – 12:50 p.m. | Industry Representative Invited

    12:50 p.m. – 1:10 p.m. | Industry Representative Invited

    1:10 p.m. – 1:30 p.m. | Regulatory Representative Invited

    1:30 p.m. – 2:00 p.m. | Q&A

  • Friday, October 23

    10:00 a.m. – 11:15 a.m. | P3: New Technology
    Moderator: Michael J. Miller, PhD, President, Microbiology Consultants, LLC.

     

    10:00 a.m. – 10:20 a.m. | Industry Representative Invited

    10:20 a.m. – 10:40 a.m. | Industry Representative Invited

    10:40 a.m. – 11:00 a.m. | Cultivation-free ATP RMM System and its Evaluation Based on Method Validation Criteria and Implementation in Pharmaceutical Water System
    Yoko Nakaim MS, Manager, HORIBA Advanced Techno, Co., Ltd.

    11:00 a.m. – 11:15 a.m. | Q&A


    11:15 a.m. – 11:45 a.m. | Exhibit Networking

    11:45 a.m. – 1:00 p.m. | P4: Ask the Experts and Regulators
    Moderator: Josh Eaton, Assistant Director, Scientific Affairs, PDA

     

    11:45 p.m. – 12:45 p.m. | Industry and Regulatory Round Table
    CDR James L. Kenney, DSc, Chief, LMIVTS, CBER, U.S. FDA

    12:45 p.m. – 1:00 p.m. | Closing Remarks


Highlighted Speakers

Sven M. Deutschmann
Sven M. Deutschmann
Roche Diagnostics GmbH
Irving Ford
Irving Ford
Bristol-Myers Squibb
Andrew D. Hopkins
Andrew D. Hopkins
AbbVie, Inc.
CDR James L. Kenney
CDR James L. Kenney
U.S. FDA
Michael J. Miller
Michael J. Miller
Microbiology Consultants, LLC
Erika A. Pfeiler
Erika A. Pfeiler
U.S. FDA
Lisa A.  Wysocki
Lisa A. Wysocki
GlaxoSithKline

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

Registration Fees

Register Now
Registration Type Fee
Member $1,196
Non-member $1,475
Young Professional Member $598
Gov’t/Health Auth./Academic Member $560
Gov’t/Health Auth./Academic Non-member* $640
Student Member $248
Student Non-member* $224

Got a Question? We have answers

Contact Us
Become a Sponsor

Interested in becoming a sponsor? Learn about opportunities and benefits.

Request Information

Exhibitors

Become an Exhibitor

Interested in becoming an exhibitor? Learn about opportunities and benefits.

Request Information

Attendee List Email Scam

Unfortunately, emails are circulating that offer to sell attendee lists for many of PDA’s conferences and events. These emails are sent by scammers.

Note: PDA does not sell its exhibitor or attendee lists, and no third-party is authorized to distribute or sell any lists related to our events. Statements claiming to offer our attendee lists are fraudulent. If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately.

Media Partners

Related Events

Contact

Program Inquiries
Exhibition Inquiries
Course Inquiries
Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
[email protected]

PDA Members Save Substantially