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PDA 481 Evaluation, Validation and Implementation of Alternative and Rapid Microbiological Testing Methods

Oct 07 - Oct 08, 2021
Washington, DC

  • Education
  • The Americas
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Overview

The control of microorganisms in our manufacturing processes and environments is one of the most important tasks in ensuring products are safe and effective. This is true for conventional pharmaceuticals, biotech products, compounding pharmacy drugs, gene and cell therapy products and radiopharmaceuticals. However, conventional microbiology methods are antiquated and do not support the need for faster, accurate and reproducible results. Therefore, the modern laboratory should develop innovative approaches for the detection, quantification and identification of microorganisms using alternative and rapid microbiological methods (RMM).

This comprehensive training course is designed to provide an intensive review of currently available RMM technologies, validation strategies, applications for use, global regulatory views and validation expectations, financial justification models, and technology identification and implementation plans.

For more options and/or related training courses, please visit the page(s) below.

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Agenda

  • Training courses generally run from 8:30 to 16:00 each day. Breakfast and lunch will be provided.

Trainers

Michael J. Miller
Michael J. Miller
Microbiology Consultants, LLC
Bio
Michael J. Miller
Microbiology Consultants, LLC

Dr. Michael J. Miller is an internationally recognized microbiologist and subject matter expert in pharmaceutical microbiology and the validation and implementation of rapid microbiological methods (RMM). He is currently the President of Microbiology Consultants, LLC (http://microbiologyconsultants.com) and owner of http://rapidmicromethods.com, a website dedicated to the advancement of rapid methods within healthcare related industries.

For 30 years, he has held numerous R&D, manufacturing, quality, business development and executive leadership roles at multinational firms such as Johnson & Johnson, Eli Lilly and Company and Bausch & Lomb. In his current role, Dr. Miller provides technical, quality and regulatory solutions in support of RMMs, sterile and non-sterile pharmaceutical manufacturing, contamination control and GMPs.

Dr. Miller has authored more than 100 technical publications and presentations and is the editor of PDA’s Encyclopedia of Rapid Microbiological Methods. He currently serves on the editorial and scientific review boards for American Pharmaceutical Review, European Pharmaceutical Review and the PDA Journal of Science and Technology. Dr. Miller was the chairperson for PDA's Technical Report #33 and currently serves as an advisor to the USP Microbiology Expert Committee in the area of rapid sterility testing.

Dr. Miller holds a Ph.D. in Microbiology and Biochemistry from Georgia State University. 

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Discuss the benefits of alternative and RMM technologies as compared with classical microbiological methods
    2. Describe the scientific basis for a variety of technologies that may be qualified as alternative methods to classical microbiology procedures
    3. Explain current regulatory viewpoints, policies and expectations for RMM validation, submissions and implementation
    4. Apply industry best practices for validating new technologies in order to demonstrate that the methods are acceptable for their intended use via IQ, OQ and PQ strategies
    5. Utilize statistical methods to demonstrate equivalence between an alternative method and the compendia method
  • Who Should Attend

    Who Should Attend

    This training course is intended for professionals who are responsible for the conduct of microbiological testing and microbial control strategies in manufacturing and product/process development.

    Departments
    Quality Control, Quality Systems, Quality Compliance, Manufacturing, Technical Operations

    Roles
    Analyst, Specialist, Operator/Technician, Supervisor, Manager

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Travel

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.

Grand Hyatt Washington

1000 H St NW
Washington, DC

  • Accommodations

    The PDA room block is not currently open. Please check back June 2021.

  • Amenities

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Registration Fees

Early Registration
Registration Type Price By August 23, 2021
Member $1,799
Non-member $2,159
Gov't/Health Auth./Academic* $1,399
Regular Registration
Registration Type Price After August 23, 2021
Member $1,999
Non-member $2,399
Gov't/Health Auth./Academic* $1,399

* For this member type or discount, online registration is not available, please contact [email protected].

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

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 immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

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