Bioprocess Services: Knowledge Institute: AccessTraining Course: Understanding Regulation of Aseptic Processing and Filtration Applications (TRAPVALID)

Understanding Regulation of Aseptic Processing and Filtration Applications

Overview (TRAPVALID - One - day course)
The course provides an in-depth review of current global regulatory practice for filtration applications in aseptic processing. Detailed discussion of the qualification and validation of these applications will enable you to answer any questions which might arise during inspections or audits.

What will you be able to do after attending this course?

Understand the regulatory authority’s current expectations for aseptic filtration and specific validation of filtration applications.
Interpret guidance on filtration and aseptic processing from the U.S. Food and Drug Administration (FDA); European Medicines Agency (EMEA); International Conference on Harmonization (ICH); Parenteral Drug Association (PDA) and International Organization for Standardization (ISO).
Understand filter validation studies such as: microbial retention testing, extractable substances determination, compatibility studies and product related filter integrity testing.
Create your own filter validation master plan for filtration.
Explain filter validation studies to your regulatory inspector.

What will you receive?

A full set of course notes.
The latest regulatory guidelines.
A certificate of attendance.

Who should attend?
The course is primarily designed for quality assurance, quality control and validation personnel with a basic understanding of filtration practice.

Course Program

Day 1 *9:00 – 17:30

Introduction.
Current regulatory requirements.
Sterile medicinal product manufacturing.
Validation Master Plan (VMP) for filtration applications.
Sterile filter – definitions and manufacturing.
Microbial retention studies.

*Includes two coffee breaks and lunch.

Filter integrity testing qualification.
Compatibility, adsorption and particle studies.
Extractable substances analysis.
Aseptic disposable solutions and validation considerations.
Filter steam sterilization qualification.
Conclusion.

Dates and Locations: Click here
This training can also be delivered on your site at a convenient time. Please contact your local EMD Millipore representative or send an email to accessknowledge@merckgroup.com to discuss this option.

Prerequisites
You should have a working knowledge of cGMP, validation, qualification and the relevant regulatory guidelines (Sterile Drug Products Produced by Aseptic Processing Current Good Manufacturing Practice, FDA Guidance for Industry, Sept. 2004 - Manufacture of Sterile Medicinal Products, EU Guidelines to Good Manufacturing Practice, Volume 4, Annex 1, Nov. 2008).

Enrollment limited to 15 participants
We recommend early booking to ensure a place.

Ordering information
Catalogue number: TRAPVALID

Price
Please contact your local EMD Millipore representative or send an email to accessknowledge@merckgroup.com for a quote.

Printable Course Description

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