Annex 2 + Co. - GMP Compliance for Biopharmaceuticals - 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). Important notes on sales tax.

Registration

* also payable by credit card

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

Speakers

Dr Markus Fido, MFI Bio-Consulting
Dr Matthias Leitritz, Rentschler Biopharma, Germany
Stephan Löw, CSL
Dr Daniel Müller, GMP Inspector, German Local Government
Axel Schroeder, Concept Heidelberg

Objectives

This Course concentrates on regulatory and practical requirements regarding biopharmaceutical production. From clinical phases to routine manufacturing practical examples and case studies will facilitate the implementation of GMP in your daily business.

The course will treat the topics of routine inspection from regulatory bodies and customers, quality assurance and quality control as well as in laboratory and production.

Speakers from manufacturing, laboratory, consultancy and authority will show their expectations as well as their experiences in GMP implementation.

Background

In defiance of all throwbacks in the last years, a progression of new approvals of biopharmaceuticals is expected. Furthermore after the end of the protection of patents, biotechnical generics will be added.

Especially in the field of biotechnology you find particular challenges to fulfil the regulatory requirements on production and quality assurance.

Industry and authorities have to face the new and expected changes in the regulatory Guidelines.

Target Group

This Training Course is advisable to people who

are involved in regulatory inspections,
work in quality units at biotech companies,
implement GMP in biotech production,
are responsible for GMP requirements pre-approval phases.

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

GMP Requirements Applying to Biotechnological Investigational Medicinal Products (IMPs of Clinical Phases I-III & APIs for use in IMPs)

EU regulations & guidances
Examples of national regulations
State-of-the-art manufacturing for clinical phases

GMP Guidelines for Biopharmaceuticals – a Brief Summary

Relevant international regulations
European biotech guidances
Recent developments & possible impacts

Development of Biopharmaceuticals - GMP and Regulatory Aspects

GMP and regulatory documents
Ways to Success
Interaction with authorities (meetings/inspections)

Development, Qualification and Validation of Process Analytics for Biopharmaceuticals

Relevant guidelines
Phases of product development / testing requirements
Method portfolio/method development / method qualification / method validation

GMP Inspections in Biopharmaceutical Production

Inspections of biopharmaceutical companies
Focus & discussion points during inspections
- Clean room classes for biotech facilities
- Open vs. closed processing
- Single vs. multi purpose equipment
- Cell banking activities
Inspector’s experience, examples of observations

Case Study: Process Transfer from Development to Commercial Production

Key Aspects for EU and US
Difference between development and commercial production

GMP-conform Process Development and Validation (incl. Equipment Qualification)

Introduction
Current initiatives in pharmaceutical development
Biopharmaceuticals / Biosimilars / Biological

Process
Analytical Methods
Equipment / Instruments and Facility

Quality Assurance for Biopharmaceuticals

Classical responsibilities of QA department
Allocation of responsibilities, training of staff
Dealing with suppliers & contractors
The world changes: Change management
Shit happens: Deviation management & CAPA
Handling complaints & product recalls
Paper, paper, paper: documentation works: SOPs, MBR, PQR & management report
Surveillance of qualification & validation, calibration and maintenance
Self inspections & auditing

Bioanalytics for Clinical Trials – Method/Process Development and Validation for Phase I – III Studies

Definitions of terms (ICH, Q’s)
Process development & quality by design
Early clinical phase
Late clinical phase
Post approval

State-of-the-art Biotechnological Manufacture (Bacteria, Yeast, Mammalian Cells) and Cell Banking Activities - Part 1

Reasons for cell banking
Where does GMP start
Characterization of cell banks
Storage of cell banks

State-of-the-art Biotechnological Manufacture (Bacteria, Yeast, Mammalian Cells) and Cell Banking Activities - Part 2

Overview of a typical biotech process
Requirements on production areas, raw materials and equipment
Specialities on biotech products
Fill and finish

Interactive Case Studies – Deviations, Root Causes, CAPA

Examples of pitfalls
Chemical interactions
Human errors
Incorrect use

Prevention of Cross Contamination: Dedicated Manufacturing or Cleaning Validation?

Requirements of Chapter 3 and 5 and Annex 2
Decision with consequences: multipurpose equipment or disposables
Dirt or product: zhe perspective defines contamination
Ways to remove contaminants: cleaning procedures and their testing
Risk-based approach: Crucial element of the validation programme

Recording of 10/11 May 2022

Duration of Recording: 11 h 50 min

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