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Parenteral Drug Association Connecting People, Science and Regulation ®

Rapid Microbiological Methods

Oct 17 - Oct 18, 2018 |
Oct 18, 2018 |
Berlin Mariott Hotel | Berlin, Germany
  • 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

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.

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, 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

3 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

Contact

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

Exterior

Berlin Marriott Hotel
Inge-Beisheim-Platz 1
10785 Berlin
Germany
Tel: +49-30-220000
Hotel Website

Showcasing spacious, impeccably appointed guest rooms and suites, a host of first-class amenities, and an unbeatable location in the heart of the city centre, the Berlin Marriott Hotel offers a seamless blend of comfort, style and convenience for your visit to Germany's capital city.

Unwind in the well-appointed hotel rooms, each of which boasts deluxe bedding, a flat-screen TV, an ergonomic workspace and a mini-bar. You'll enjoy the wide variety of outstanding on-site resources, such as a state-of-the-art fitness center and indoor pool, an authentic steakhouse and a sleek, inviting hotel bar.

Guests looking to host a successful meeting or wedding here in Germany will be thrilled with the 18,277 square feet of sophisticated event space, the expert planning and catering teams and the accessible location in Berlin city centre. The hotel is situated two blocks from Potsdamer Platz, and near the Brandenburg Gate and the Gendarmenmarkt. Allow the Berlin Marriott Hotel to redefine the meaning of contemporary elegance.

PDA Europe has reserved a limited number of rooms until the 14th August 2018.
Book your room for the PDA Group Rate.

Single Room € 195 per night*
Double Room € 215 per night*

*Rates are per room and night, including the following services and benefits free of charge:
  • Buffet Breakfast in the restaurant
  • Wireless Internet Connection (WI-FI)
  • VAT, Taxes and Service Charge will apply

How to Get There

Berlin-Tegel Airport – TXL
Airport Phone: +49 30 60911150
Hotel direction: 5.6 miles SE

Berlin-Schoenefeld International Airport – SXF
Airport Phone: +49 30 60911150
Hotel direction: 12.3 miles NW

This hotel does not provide shuttle service.

Parking

  • On-site parking, fee: 3.5 EUR hourly, 30 EUR daily

Photos

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

Register Now
https://store.pda.org/Meetings/Login.aspx?ID=4160

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