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2019 BioManu

Classical or Rapid Microbiological Methods?

Sep 05 - Sep 06, 2019
Munich, Germany

  • Education
  • Europe

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Overview

The monitoring of microbial contamination is one of the critical procedures in the control of the manufacturing process and quality of the finish products in pharmaceutical industry. Many compendial methods used today offer low probability of detection except for gross contaminations. Rapid microbiological methods start to gain track in the industry, due to their increased adoption and validation, but also because of the clarification from the regulators. There are several well-developed rapid microbiological methods now becoming available that may have useful applications in pharmaceutical and medical devices.

The advent of the new therapies like the Advanced Therapy Medicinal Products, Cell and Gene Therapy that makes products with a short shelf life or products prepared for immediate use sorts the needs for rapid microbiological methods that allowed the minimization and mitigation of the risk of contamination.

The pharmacopeias have evolved as well to provide guidance on the selection, evaluation, validation and proper implementation of rapid microbiological methods as alternatives to compendial methods.

This training will be focused on the understanding of the classical methods described in the pharmacopeia and the currently available rapid microbiological method technologies, the regulatory requirements, the validation strategies and implementation plans.

Agenda

  • Day 1
  • Day 2
  • Thursday, 5 September 2019

    9:00
    Welcome and Introduction


    9:10
    Why Be Interested in Alternative and Rapid Methods? Rapid Versus Classical Methods?


    10:30
    Coffee Break

    11:15
    What is the Pharmacopeias Request?

    • Regulatory policies and their expectations

    11:40
    Lunch Break

    12:40
    What Are the Main Rapid Micro Methods?


    13:40
    Automatization of Traditional Techniques


    14:30
    Coffee Break

    15:00
    Direct Measurement and Technologies


    15:50
    Based-growth Technologies


    16:45
    End of Day 1
  • Friday, 6 September 2019

    9:00
    Technologies Based on the Detection of Cellular Components


    9:50
    Technologies for Real Time Measurement


    10:40
    Coffee Break

    11:10
    Validation Part 1


    12:10
    Lunch Break

    13:10
    Validation Part 2


    14:10
    Rapid Sterility Testing/ATMPS /Trends


    15:00
    Coffee Break

    15:30
    ROI of Rapid Methods


    16:20
    Recap, Q&A


    16:45
    End of Course

Trainers

Félix Alejandro Montero Julian
Félix Alejandro Montero Julian
BioMérieux

Additional Information

  • Learning Objectives

    Learning Objectives

    Upon completion of the course participants

    • Know the benefits of alternative and rapid microbiological methods in regards of the compendial methods
    • Know the pros and cons of classical vs. alternative/rapid methods
    • Can describe the scientific science behind the different technologies: classical, alternative and rapid methods.
    • Apply the regulatory frame governing the rapid methods. USP 1223, Ph Eur Chapter 5.1.6, PDA TR33
    • Explain the implementation and validation of rapid methods
    • Develop a return on investment scenario

    Rise the new USP 1071 Rapid Sterility Testing of Short-Life Products: A Risk-Based Approach

  • Who Should Attend

    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 Functions:

    • Supervisors
    • Researchers
    • Analysts
    • Operative Personnel
    • Manufacturing
  • 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: Not Applicable

    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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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.

Sheraton Munich Arabellapark Hotel

Arabella Strasse 5
Munich, Germany
Phone: +49 (0)89 92320

Sheraton Munich Arabellapark Hotel
  • Accommodations

    Hotel Website

    The elegant 4-star Sheraton Munich Arabellapark Hotel offers a soundproof accommodation in a residential area of Munich. Featuring chic architecture, the hotel was renovated in 2007. The property is located in Bogenhausen district, 3.5 km from Marienplatz. The city center lies within 4 km from the venue.

    A spectacular view over the countryside welcomes guests to club superior king suite, junior king suite and executive flat with modern-style décor. The property boasts views of Alps from its rooms. Room facilities also include a microwave, an electric kettle and coffee/tea makers for self-catering. The property is in a 5-minute walking distance from Richard-Strauss-Straße subway station. It will take 35 minutes to get to Franz Josef Strauss airport by car.

    PDA Europe has reserved a limited number of rooms until the 15th June 2019.
    Book Your Room for the PDA Group Rate.

    Single Room € 169 per night* 
    Double Room € 194 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 will apply
  • Amenities

How to Get Here

By Air

Nearest Airport: Munich Airport - MUC
Airport Phone:
+49 89 975 00

By Car

21.7 mi (35 km), 29 min by car. Sheraton Munich Arabellapark Hotel is located at ArabellaStrasse 5, Munich 81925 Germany.

Other Options

Estimated taxi fare: 55 EUR (one way).

Bus service fee: 10.5 EUR (one way).

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants €1.595

All fees given in Euro and excluding VAT

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

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

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