Bioburden - Online Training Recording

Bioburden - Online Training Recording

Costs

ECA-Member*: EUR 1590,--
Regular Fee*: EUR 1790,--
EU/GMP Inspectorates*: EUR 895,--
APIC Member Discount*: EUR 1690,--

(All prices excl. VAT)

* also payable by credit card American Express Visa Mastercard

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Speakers

Dr Jörg Degen, ITM Isotopen Technologien München, Germany
Dr Daan de Gouw, MSD, The Netherlands
Dr Sven M. Deutschmann, Roche Diagnostics, Germany
Nicole Klüh, Labor LS, Germany
Dr Sebastian Thölken, Novartis Pharma Stein, Switzerland
Radhakrishna Tirumalai, Ph.D., USP

Objectives

During this course, the following contents and questions should be addressed by presentations and panel discussions.  Considering that, panelists from the fields Non-Sterile Products, Sterile Products, Combination Products as well as biopharmaceutical APIs and HCT/Ps will on hand for the training.

Background

In their Pharmacopeial Forum 39(4) in 2014, the USP published the draft of chapter <1115> “Bioburden Control of Nonsterile Drug Substances and Products”. The document outlines a risk-based approach to the control of potential contamination in non-sterile product manufacturing.

But “bioburden” is not only a topic of Non-Sterile Products. Annex 1 of the European GMP Guideline requires “The bioburden should be monitored before sterilisation. There should be working limits on contamination immediately before sterilisation, which are related to the efficiency of the method to be used. Bioburden assay should be performed on each batch for both aseptically filled product and terminally sterilised products.”

And last but not least, bioburden testing for medical devices made or used in the USA is governed by Title 21 of the Code of Federal Regulations and worldwide by ISO 11737.

The current developments determines us to address this topic in a special workshop session to look at this from various angles and provide you with information about the regulatory background and practical examples and strategies for bioburden control. Pharmacopoeial experts, representatives of pharmaceutical quality control and from testing laboratory will show you what are the challenges of the bioburden control strategy and how they implemented an adequate control in their companies.

Target Group

This Course is of interest to professionals in microbiology from
  •  Pharmaceuticals and Biopharmaceutical Companies
  •  Academic Research Institutions
  •  Government Agencies
  •  Contract Service Laboratories
who are involved in
  •  Research and Development
  •  Validation
  •  Microbiological QA and QC

Technical Details:

To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.

Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your Needs.

In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.

Please be aware: The recording does not include the Q & A sessions.

Training Course Documentation and Certificate:
The presentations will be made available as PDF files via download shortly before the online training course.  After the event, you will automatically receive your certificate of participation.

Programme

General Information
  • Bioburden control strategy dependent of the lifecycle phase of the product (so-called “Phase-appropriate control strategy”)
    • Early clinical Phase
    • Late clinical Phase
    • Commercial phase
  •  Test for “specified microorganisms” and / or “objectionable microorganisms”?
    • Raw materials
    • In-process-control samples
    • Drug substance
    • Drug product
    • Final product
  •  Refresher on biofilms including case studies
    • Biofilm biology
    • How to recognize biofilms in bioburden trends
    • Lessons learned from a company
Testing
  • Where is bioburden tested in processes?
  • Predefinition of  bioburden and / or endotoxins levels for raw materials
  • Assessment of  the presence / absence of “objectionable microorganisms” in your raw materials ?
  • What are the method in use ?
    • TAMC
    • TYMC
    • MPN
    • Any other bioburden testing method
    • Rapid micro methods
  • Is it necessary to  have a limited shelf life for bioburden samples?
  • How to treat so called “missing bioburden” results ?
Limits
  • Predefined bioburden and / or endotoxins levels for your upstream / fermentation processes (if applicable) and downstream processes or for the whole process
  • What will be preferred? A two-tiered-control system (warning and alert level) or a three-tiered control system (warning and alert level AND rejection level)?
  • Methodologies in use to define the limits, e.g.
    • how many data points are required to define the Limits
    • philosophy for new processes / new manufacturing processes without having experience of process capabilities
Deviation Management
  • Do you perform ID? If YES, when:
    • Each colony
    • Only in case of an excursion of limits / Level
  • What’s the preferred ID technique?
  • Measures in case of an excursion of a Limit
USP <1115> and USP<1229.3>
  • „Bioburden Control of Non-sterile Drug Substances and Products” – USP and Industrial View
  • Bioburden Monitoring , USP<1229.3> applies to Sterile Products
Presentation list:
  • USP<1115> Bioburden Control of Non-Sterile Drug Substances and Products
  • Refresher on biofilms including case studies
  • Microbial Control Strategy for Biopharmaceutical Manufacturing
  • Microbial Counts and  Bioburden of Combination Products: Guidelines, Specifics and Case Studies
  • Bioburden for Sterile Operations
  • Bioburden Monitoring , USP<1229.3> applies to Sterile Products
  • Bioburden Testing of Modern Medicinal Products- Practical Experience of  a Contract Lab
    • Various types of bioburden testing 
    • Technical challenges: Non-Steriles up to ATMP
    • Practical Examples - from classic Pharmaceutical Products to HCT/Ps
  • Assessment of Bioburden Excursions in Non-Sterile Biologics Manufacturing Processes
 
Recording from 8/9 June 2022
Duration of Recording: 6 h 55 min

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