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Rapid Microbiological Methods

Oct 17 - Oct 18, 2018
Berlin, Germany

This comprehensive course is designed to provide an intensive review of currently available rapid microbiological method (RMM) technologies, validation strategies, applications, regulatory expectations, financial justification models and implementation plans.

  • Education
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Program Highlights

This comprehensive course is designed to provide an intensive review of currently available rapid microbiological method (RMM) technologies, validation strategies, applications, regulatory expectations, financial justification models and implementation plans.

Overview

This comprehensive course is designed to provide an intensive review of currently available rapid microbiological method (RMM) technologies, validation strategies, applications, regulatory expectations, financial justification models and implementation plans.The use of rapid methods for conventional pharmaceuticals, biotech and short shelf life products, including advanced therapeutic medicinal products (ATMP; gene and cell therapy) will be specifically integrated into the discussions.

Taught by one of the industry’s global leaders in rapid methods, the attendee will be immersed in discussions that will provide a meaningful and understandable roadmap for how to evaluate RMMs and employ them in their own laboratory and manufacturing areas.

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

Learning Objectives

  • Discuss the benefits of alternative and RMM technologies as compared with classical microbiological methods
  • Describe the scientific basis for a variety of technologies that may be qualified as alternative methods to classical microbiology procedures; explore case studies and actual workflows for dozens of commercially-available technologies
  • Explain the regulatory environment, guidance, policies and expectations for validation, submissions and implementation from FDA, EMA, TGA, PMDA, ISO and WHO; understand when and how to change acceptance levels
  • Develop business plans and return on investment justifications, follow an actual case study in significant cost savings and cost avoidances by implementing a RMM for environmental monitoring
  • Apply industry best practices for validating these new technologies in order to demonstrate that the methods are acceptable for their intended use via IQ, OQ and PQ qualification strategies; understand the differences between PDA TR 33, USP <1223> chapter and Ph. Eur. Chapter 5.1.6
  • Appreciate new guidance for rapid sterility testing of advanced therapeutic medicinal products (ATMP; gene and cell therapy) including compendial expectations and regulatory acceptance; justification for sample size allowances and the latest validation strategies
     

Instructor

Michael J. Miller, PhD, President, Microbiology Consultants, President
Michael J. Miller is an internationally recognized microbiologist and subject matter expert in pharmaceutical microbiology, contamination control, aseptic processing, sterilization, laboratory design and the validation and implementation of rapid microbiological methods (RMM). He is currently the President of Microbiology Consultants, LLC. 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, Michael consults with multinational companies in providing technical, quality, regulatory and training solutions in support of RMMs, sterile and non-sterile pharmaceutical manufacturing, contamination control, isolator technology, environmental monitoring, sterilization and antimicrobial effectiveness. Michael Miller has authored more than 100 technical publications and presentations and is the editor of PDA’s Encyclopedia of Rapid Microbiological Methods and was also the chairperson during the revision of PDA Technical Report #33: Evaluation, Validation and Implementation of New Microbiological Testing Methods. He currently serves as an advisor to the USP Microbiology Expert Committee in the area of rapid sterility testing. Michael Miller holds a Ph.D. in Microbiology and Biochemistry from Georgia State University (GSU), a B.A. in Anthropology and Sociology from Hobart College.

Agenda

  • Wednesday, 17 October 2018

    9:00
    Welcome


    9:15
    Introduction to RMMs, Applications, Implementation Strategies, Opportunities
    Growth-based RMMs; Scientific Principles, Applications and Case Studies


    10:30
    Coffee Break

    11:00
    Regulatory Policies and Expectations: FDA, EMA, TGA, PMDA, ISO and WHO


    12:30
    Lunch Break

    13:30
    Cellular-component Based RMMs; Scientific Principles, Applications and Case Studies
    Viability-based RMMs; Scientific Principles, Applications and Case Studies


    15:30
    Coffee Break

    16:00
    Spectroscopic-based RMMs; Scientific Principles, Applications and Case Studies
    Genetic and Gene Amplification-based RMMs Part 1; Scientific Principles, Applications and Case Studies


    18:00
    End of Day 1

    Thursday, 18 October 2018

    9:00
    Genetic and Gene Amplification-based RMMs Part 2; Scientific Principles, Applications and Case Studies


    10:30
    Coffee Break

    11:00
    MEM-based RMMs; The Future of Alternative Technologies
    Validation of RMMs Part 1; Due Diligence Activities, Vendor Expectations, IQ, OQ and PQ Strategies, Validation Acceptance Criteria, Use of Statistics


    12:30
    Lunch Break

    13:30
    Validation of RMMs Part 2; Equivalence, Method Suitability, Comparison of PDA TR33, USP <1223> and Ph. Eur. 5.1.6
    A Case Study on Conducting Economic Assessments and Return-on-Investment (ROI) Calculations


    Review of ATMP (gene and cell therapy) expectations for rapid sterility testing according to the revised Ph. Eur. Chapter 2.6.27


    15:00
    Coffee Break

    15:30
    References, On-line Resources and Final Remarks


    16:30
    End of Training Course

Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    More information coming soon.

  • Accreditation

    Accreditation

    Continuing Education for Pharmacists

    ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

    PDA # / ACPE # / CEUs:
    Type of Activity:

    ALERT   ACPE and NABP developed the CPE Monitor that allows pharmacists to electronically track their continuing pharmacy education (CPE) credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE-accredited activity. Always submit CPE activity claims as soon as possible. For more information, please visit the ACPE or NABP website.
    Continuing Education for Professional Engineers
    New Jersey

    PDA is an approved provider by the New Jersey State Board of Professional Engineers and Land Surveyors to offer courses to New Jersey Professional Engineers for Continuing Professional Competency (CPC) credit. Following the full participation in this course, participants will receive a Certificate of Accomplishment specifying the number of CPC credits that may be awarded. This certificate can be submitted as verification of completion to the Board for license renewal.

    The credit value of this course is CPC credits.
    North Carolina

    PDA is recognized by the North Carolina Board of Examiners for Engineers and Surveyors as an Approved Sponsor of Continuing Professional Competency (CPC) activities for Professional Engineers licensed by North Carolina. To receive a Certificate of Accomplishment specifying the number of Professional Development Hours (PDH) that may be awarded, course participants must request the North Carolina Board of Examiners evaluation form from PDA staff. This form must be completed onsite at the conclusion of the course and returned to PDA staff.

    The credit value of this course is PDH credits.

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Berlin Mariott Hotel

Inge-Beisheim-Platz 1
Berlin, Germany

How to Get Here

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If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. She will verify your status and register you.

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  • No PDA membership obtainable upon booking training course, workshop or other related event.

Registration Fees

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All Participants

1495 Euro

Contact

Antje PetzholdtAntje Petzholdt
Manager Registration, Chapters & Membership
Tel: +49 (0) 30 43 655 08-10
Fax: +49 (0) 30 43 655 08-66

* For Government/Health Authority/Academic nonmembers, online registration is not available and must be faxed in.

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