Handling biological Raw Materials & APIs - Online Training Recording

Speakers

Dr Katja Aschermann

Astator

Dr Armin Hauk

Sartorius Stedim Biotech

Dr Ana Kuschel

West Pharmaceutical Services

Melanie Braun

Labor LS

Anna Liznar

PathoQuest

Stefan Gärtner

Labor LS

Raphael Parusel

TETEC

Objectives

This online training is designed to address challenges such as mitigating risks of contamination, degradation and supply chain disruption. It provides industry professionals with the knowledge and skills needed to ensure compliance and optimise their processes for handling biological raw materials and active pharmaceutical ingredients.

Background

Raw materials, excipients and other products used in the manufacture of biologics must be well understood in terms of their role in the manufacturing process. Particularly in a GMP regulated environment, these raw materials, components and excipients require thorough control for consistent quality.

Therefore, all critical quality attributes should be known and appropriate risk mitigation and control strategies should be established. Since there is currently less written guidance on risk-based management of biological raw materials, European Pharmaceutical Enterprises, EBE, has prepared a concept paper entitled “Management and Control of Raw Materials Used in the Manufacture of Biological Medicinal Products.”

But other approaches can also be helpful - a look at Annex 1 for products that need to be sterile or have a low bioburden claim. Or the QbD approaches for consistent quality of products.

Target Group

This training will be highly valuable for:

Laboratory managers
Quality control managers
Analytical scientists
Senior laboratory personnel
QA Units
Qualified Persons (QPs)

It is designed for professionals from biopharmaceutical companies, ATMP developers, and manufacturers. Additionally, the training is relevant for employees of contract laboratories involved in method development, control testing, and quality assurance.

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 presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.

Programme

Classification and Regulatory Aspects of Biological Raw Materials
(Katja Aschermann)

Starting Materials
Biological Raw Materials
Novel Excipients

QbD Approach to Registration of Raw Materials
(Katja Aschermann)

Introduction to the QbD Approach
Target Material Profiles and Critical Quality Attributes
Development of a QbD Approach for Raw Materials
Examples

Process-related Leachables
(Armin Hauck)

What are Process Equipment Related Leachables (PERLs)
Bioprocessing using Single Use Systems (SUS)
- Regulatory requirements
- The dedicated concerns
Extractables Studies for SUS
The extrapolation of extractables data to PERL exposure data
PERL in safety and risk assessment
PERL mitigation concepts

The Search for Ideal Biologics Containment
(Ana Kuschel)

Materials types and requirements
Selection criteria considerations
Regulatory landspace overview
Current solutions for biologics

Raw Material Qualification for Cell Therapies
(Katja Aschermann)

From Risk Profile to Material Qualification
Examples
Quality Control of Raw Materials

Microbiological Safety: Protection Strategies for Product Quality and Health
(Melanie Braun)

Basic principles of industrial Hygiene
Risk factors for microbiological contamination
Case studies
Prevention strategies, monitoring and controls

Viral Contamination Risk Control Strategy
(Anna Liznar)

Regulatory aspects in viral safety of biological raw materials
Viral risk identification with NGS
Considerations for viral safety of biological raw materials used in ATMP production

Rapid Microbiological Control of Raw Materials
(Stefan Gärtner)

General requirements for (rapid) bioburden, sterility and endotoxin Tests
Handling of small and/or complex sample volumes
Design of validation studies
Overview of different rapid methods for different matrices

Combined Products: Ensuring Compliance and Quality
(Raphael Parusel)

Combined products (medical devices and medicinal products)
CE labelling
Legal manufacturer and Distributor
Requirements of the MDR
Requirements of ISO13485

Effective Storage Solutions
(Raphael Parusel)

GMP warehouse structure
Documentation
Storage of medicinal products and medical devices
Hygiene and Monitoring
Implementation of ERP systems
GDP

Recording from 18/19 March 2025
Duration of the recording: approx. 6 h 30 min.

This course is part of the GMP Certification Programme "ECA Certified Biotech Manager" Learn more

ECA-Member*:	€ 1890,-
Regular Fee*:	€ 2090,-
EU/GMP Inspectorates*:	€ 1045,-
APIC Member Discount*:	€ 1990,-

(All prices excl. VAT). Important notes on sales tax.

Registration

* also payable by credit card

Further dates on-site

Further dates on-site
Not available

Further dates online

Further dates online
Not available

Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org

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