Rapid Microbiological Methods

Berlin, Germany
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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.

Note   In response to considerable demand, all participants will now be given access to electronic course notes, which may be printed once for use during the course approximately 1 – 2 weeks in advance. Hard copies of course notes will no longer be provided to participants.

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.

More information coming soon.

ALL PRICES IN EURO (EUR), EXCLUDING VAT.

WAYS TO REGISTER: 1. Online Registration   2. [email protected]

PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact [email protected] before registering.

If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.

Day 1

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
Agenda is subject to change.

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.

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