Skip To The Main Content
2022 Microbial Data Deviations

2022 PDA Microbial Data Deviation Investigations Conference

Nov 16 - Nov 17, 2022
Eastern Standard Time | Online
  • Conference
  • Virtual
  • Online
Program Highlights

The 2022 PDA Microbial Data Deviation Investigations Conference starts this Wednesday, 16 November!

Overview

Microbiological data deviations result from microbial test results that fall outside the product specification or acceptance criterion established in a drug application, drug master file, official compendia, good manufacturing practice regulations, or internally by the manufacturer. The term “microbial data deviation” is preferred to “out-of-specification” or “out-of-limit result”, as most microbiological tests, especially in a sterile product manufacturing facility, are in-process tests, not finished- product tests that must meet a regulatory-approved specification. This is an area of continued focus for regulatory authorities during inspections and document reviews. However, it is also an area of limited guidance from health authorities.
 
Attend the 2022 PDA Microbial Data Deviation Investigations Conference to get both a recap of the newly developed PDA Technical Report No. 88 (TR 88) Microbial Data Deviation Investigations in the Pharmaceutical Industry, as well as real world examples that can be used to develop and improve your current approaches and strategies to manage these events.

Agenda

  • Day 1
  • Day 2
  • WEDNESDAY, 16 NOVEMBER

    09:00 – 10:25 | P1: Investigation Playbook
    Moderators: Marc Glogovsky, MS, SM (NRCM), Business Unit Manager/Senior Consultant - Microbiology, ValSource, Inc. and Christopher A. Murdock, PhD, CQA, Senior Director, Global Quality Systems, Bristol Myers Squibb

    In this opening session, the presenters will discuss tools and points to consider for conducting effective, thorough, and efficient investigation and root cause analysis. They will focus on how to use your investigation team to determine the true root cause and areas that are often overlooked during a microbial data deviation event.

    09:00 | Welcome Remarks from Co-Chairs
    Marc Glogovsky, MS, SM (NRCM), Business Unit Manager/Senior Consultant - Microbiology, ValSource, Inc.
    Christopher A. Murdock, PhD, CQA, Senior Director, Global Quality Systems, Bristol Myers Squibb

    09:10 | Why Can't I Find the Definitive Root Cause? Important Points to Consider
    Paula J. Peacos, MS, Senior Consultant, ValSource, Inc.

    09:40 | Walking the Talk: The Importance of Microbiology on the Manufacturing Floor
    Kim Sobien, MBA, MSAT Contamination Control Lead, GSK

    10:10 | Q&A

    10:25 – 10:35 | Break

    10:35 – 12:20 | P2: Laboratory Investigations
    Moderators: Marc Glogovsky, MS, SM (NRCM), Business Unit Manager/Senior Consultant - Microbiology, ValSource, Inc. and Christopher A. Murdock, PhD, CQA, Senior Director, Global Quality Systems, Bristol Myers Squibb

    In this session, the presenters will discuss Laboratory, or Phase 1, Investigations in response to microbial data deviations (MDD). Comprehensive and timely lab investigations are critical to establish whether an error was made, which would invalidate the test results so the test may be repeated. The timely completion of the first phase of the investigation is important so a cross-functional team can be put together rapidly to 1) conduct the manufacturing investigation to establish the probable cause of the failure; 2) complete Corrective Actions and Preventive Actions (CAPA) as required by cGMP regulations; and 3) finalize the disposition of the manufacturing batch. The presenters will also discuss the new FDA regulations on quality metrics reporting as they emphasize investigations and are seen as a tool to measure and improve laboratory performance.

    10:35 | Non-Sterile Product Testing
    Tony Cundell, PhD, 
    Principal Consultant, Microbiological Consulting, LLC

    11:05 | Sterility Test MDD: Concepts for Conducting Laboratory and Manufacturing Investigations
    Dennis E. Guilfoyle, MS, PhD, Senior Director, Microbiology Regulatory Compliance, Johnson & Johnson

    11:35 | Ancillary Testing Micro Data Deviation and Utilities
    Julie Barlasov-Brown, MBA, Director Microbiology, Glenmark Pharmaceuticals

    12:05 | Q&A

    12:20 – 12:30 | Break

    12:30 | P3: Day 1 Closing Panel Discussion
    Moderators: Marc Glogovsky, MS, SM (NRCM), Business Unit Manager/Senior Consultant - Microbiology, ValSource, Inc. and Christopher A. Murdock, PhD, CQA, Senior Director, Global Quality Systems, Bristol Myers Squibb

    12:30 | Panel Discussion (25 min)
    Julie Barlasov-Brown, MBA, Director Microbiology, Glenmark Pharmaceuticals
    Tony Cundell, PhD, Principal Consultant, Microbiological Consulting, LLC
    Dennis E. Guilfoyle, MS, PhD, Senior Director, Microbiology Regulatory Compliance, Johnson & Johnson
    Paula J. Peacos, MS, Senior Consultant, ValSource, Inc.
    Kim Sobien, MBA, MSAT Contamination Control Lead, GSK

    12:55 | Closing Remarks from Co-Chairs
  • THURSDAY, 17 NOVEMBER

    09:00 – 10:35 | P4: Manufacturing Investigations
    Moderators: Marc Glogovsky, MS, SM (NRCM), Business Unit Manager/Senior Consultant - Microbiology, ValSource, Inc. and Christopher A. Murdock, PhD, CQA, Senior Director, Global Quality Systems, Bristol Myers Squibb

    In this plenary session, the presenters will expand PDA TR88’s systematic manufacturing investigations approach and provide attendees with a roadmap to improve their contamination control strategy using a structured tool to deal with complex investigations following loss of environmental control in the cleanroom.

    Beginning with “A Roadmap to a Successful Cleaning and Disinfection Program,” the key concerns in the industry related to their cleaning and disinfection program such as biocidal selection, cleaning frequency, wet contact time, fungal spore outbreaks, rotation, residues, and disinfectant validation will be discussed. Then, “The Restart Process as a Tool in Microbiological Manufacturing Investigations” will propose a structured approach to manage unplanned events which have led to a loss of environmental control,  to set the process for driving the environment back to the controlled state, ensuring that the right subject matter experts are involved on the team and the needed tasks (e.g., cleaning and disinfection, EM) are performed sequentially and are satisfactory prior to resuming manufacturing.

    09:00 | Welcome Back and Recap from Co-Chairs

    09:15 | The Restart Process as a Tool in Microbiological Manufacturing Investigations
    Dona B. Reber, MEd, SM (NCRM), 
    Principal Consultant, AccurateMicrobiology.com
    Francesco Boschi, Senior Manager Technical Services - Global Microbiology and Aseptic Support Team (MAS), Pfizer

    09:45 | A Roadmap to a Successful Cleaning and Disinfection Program
    James N. Polarine, Jr., MA, Senior Technical Service Manager, STERIS Corporation

    10:15 | Q&A

    10:35 – 10:45 | Break

    10:45 – 12:05 | P5: Sterility Assurance Principles
    Moderators: Marc Glogovsky, MS, SM (NRCM), Business Unit Manager/Senior Consultant - Microbiology, ValSource, Inc. and Christopher A. Murdock, PhD, CQA, Senior Director, Global Quality Systems, Bristol Myers Squibb

    This session will review several elements required to provide sterility assurance in a pharmaceutical manufacturing process. From facility design, utility and environmental monitoring programs to proper gowning and aseptic practices, each of these elements contribute to the quality of a drug product. The presenters will discuss the role that a microbiologist plays in ensuring contamination is controlled in the manufacturing areas, as well as providing quality control in the laboratory when establishing both in-process and finished product release testing. But that's not all, aseptic process simulations and properly investigating contaminating events are all part of the knowledge base that a pharmaceutical microbiologist must possess. Participants will learn how to incorporate these skills into your everyday processes.

    10:45 | Microbiology Matters: From Bench to Batch
    Vanessa Vasadi Figueroa, MA, Chief Microbiologist, VVF Science

    11:15 | Microbiology Contamination Control Considerations
    Thomas J. Arista,
    Consumer Safety Officer, ORA, U.S. FDA (INVITED)

    11:45 | Q&A

    12:05– 12:25 | Break

    12:25 | P6: Day 2 Closing Panel Discussion
    Moderators: Marc Glogovsky, MS, SM (NRCM), Business Unit Manager/Senior Consultant - Microbiology, ValSource, Inc. and Christopher A. Murdock, PhD, CQA, Senior Director, Global Quality Systems, Bristol Myers Squibb

    12:25 | Panel Discussion
    Thomas J. Arista, Consumer Safety Officer, ORA, U.S. FDA (INVITED)
    Francesco Boschi, PhD, Senior Manager Technical Services - Global Microbiology and Aseptic Support Team (MAS), Pfizer
    James N. Polarine, Jr., MA, Senior Technical Service Manager, STERIS Corporation
    Dona B. Reber, MEd, SM (NCRM), Principal Consultant, AccurateMicrobiology.com
    Vanessa Vasadi Figueroa, MA, Chief Microbiologist, VVF Science

    12:55 | Closing Remarks from Co-Chairs

Highlighted Speakers

Tony Cundell
Tony Cundell
Microbiological Consulting, LLC
Vanessa Vasadi  Figueroa
Vanessa Vasadi Figueroa
VVF Science
Dennis E. Guilfoyle
Dennis E. Guilfoyle
Johnson & Johnson
Paula Peacos
Paula Peacos
ValSource, Inc.
James N. Polarine, Jr.
James N. Polarine, Jr.
STERIS Corporation
Dona B. Reber
Dona B. Reber
AccurateMicrobiology.com
Kim Sobien
Kim Sobien
GSK

Registration Fees

Register Now
Registration Type By 18 September After 18 September
Member $895 $1,395
Non-Member $1,195 $1,695
Gov./Health Authority/Academic (Member/Non-Member) $700 $700
Student (Member/Non-Member) $350 $350
Early Career Professional (Member Only) $695 $695

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

Contact

Program Inquiries
  • Molly E. O’Neill, CMP
    Vice President
    Tel: +1 (301) 656-5900 ext. 132
Exhibition Inquiries
Course Inquiries
Registration Customer Care

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

PDA Members Save Substantially