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2020 BioMan

Classical or Rapid Microbiological Methods?

Sep 24 - Sep 25, 2020
Dublin, Ireland

  • 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, 24 September 2020

    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, 25 September 2020

    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

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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.

Crowne Plazy Dublin Airport

Northwood Park
Dublin, Ireland
Phone: +353 1 862 8888

Crowne Plazy Dublin Airport
  • Accommodations

    Hotel Nearby
    PDA Europe recommends the reservation at one of the following hotel.
    The general terms of business are valid at the event hotels.


    Crowne Plaza Dublin Airport
    Northwood Park
    Santry Demesne
    Dublin 9

    The hotel is a 5-minute drive from Dublin Airport, with a free shuttle to and from the airport. It has luxurious rooms, free internet and good bus links to the city centre.
    Each bedroom has air conditioning, an on-demand movie system, a safe and ironing facility.Crowne Plaza Dublin Northwood is set in parkland, close to the M1 and M50, and 15 minutes from Dublin city centre.

    Northwood Crowne Plaza has a coffee bar, the Cinnabar Red Bar and a Californian-Asian restaurant, for a great variety of food and drinks. Breakfast starts early at 06:00. Crowne Plaza Northwood offers a park and fly facility and is on the airport bus route. Omni Shopping Centre, Swords Pavillions, Movie Plex and Northwood Business Campus are nearby. Croke Park Stadium is a short drive away.

    PDA Europe has reserved a limited number of rooms until the 24th July 2020
    Book your room for the PDA Group Rate

    • Single Superior Room € 159 per night*
    • Double Superior Room € 189 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
  • Amenities

How to Get Here

By Air

Nearest Airport:

Dublin Airport - DUB
Airport Phone: +353 1 814 1111
9km , 10 min by car
Free Shuttle Bus fom and to the Hotels

By Car

The hotel is almost 10km away from the Dublin Airport.

Other Options

More information coming soon.

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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If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

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