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Parenteral Drug Association Connecting People, Science and Regulation ®

Rapid Microbiological Methods

Nov 09 - Nov 10, 2017 |
Nov 10, 2017 |
| Vienna, Austria
  • Education
  • Europe
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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.

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, the new USP 1223 chapter and the proposed Ph. Eur. Chapter 5.1.6
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Instructor

Michael J. Miller, PhD, President, Microbiology Consultants, President
Dr. Michael J. Miller is an internationally recognized microbiologist and subject matter expert in pharmaceutical microbiology and the design, validation and implementation of rapid microbiological methods. He is currently the President of Microbiology Consultants, LLC. In this role, he is responsible for providing scientific, quality, regulatory and business solutions for the pharmaceutical industry and suppliers of new microbiology technologies. Michael currently serves on a number of PDA’s program and publication committees and advisory boards, and is co-chairing the revision of PDA Technical Report #33: Evaluation, Validation and Implementation of New Microbiological Testing Methods. Dr. Miller holds a PhD in Microbiology and Biochemistry from Georgia State University (GSU), a BA in Anthropology and Sociology from Hobart College, and is currently an adjunct professor at GSU.

Thursday, 9 November 2017

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

Friday, 10 November 2017

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, the New USP 1223 and the Proposed Ph. Eur. 5.1.6

  • A Case Study on Conducting Economic Assessments and Return-on-Investment (ROI) Calculations

15:00
Coffee Break

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

16:30
End of Training Course

4 Ways to register

Please remember to log in if you are a member of PDA already! 

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.

  • All registrations which will involve visa matters will have to be submitted to PDA EU four weeks prior to the start of the event at the latest. For later registrations, PDA Europe will be unable to assist participants in any visa affairs.
  • All costs incurring in connection with visa affairs shall be borne by registrants. (This applies in particular to costs for submitting documents by courier.)
  • Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration).
  • No PDA membership obtainable upon booking training course, workshop or other related event.

Registration Fees

Are you entiteld to receive a discount? Need Help?

All Participants

1495 Euro

All fees given in Euro and excluding VAT (23%)

Contact

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

Austria Center Vienna
Internationales Amtssitz- und Konferenzzentrum Wien, AG
Bruno-Kreisky-Platz 1
A-1220 Vienna

Hotel Accommodation

optiMICE is the official housing provider for The Universe of Pre-filled Syringes and Injection Devices 2017 . We recognize that attendees have many options with area hotels, and that you may be looking only at the per night cost in making your decision. However, we encourage you to understand the importance and recognize the benefits of selecting an official PDA Europe hotel.

Sponsorship and Exhibit Opportunities are Available!

For more information about exhibit and sponsorship opportunities, please contact:

Nadjeschda Gomez-Stahl
Manager Exhibition & Sponsorship
Tel: +49 (0) 30 43 655 08-23
Fax: +49 (0) 30 43 655 08-66
Email

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https://store.pda.org/Meetings/Login.aspx?ID=3769
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