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Course No 17013

Annex 2 & Co - GMP Compliance for Biopharmaceuticals

16-17 May 2019, Vienna, Austria

Non-ECA Members: EUR 1.790,--
ECA Members: EUR 1.590,--
EU GMP Inspectorates: EUR 895,--
Academic Scientists/ Students: EUR 895,--
APIC Members (does not include ECA membership): EUR 1.690,--
(All prices excl. VAT)

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


Dr Markus Fido, Vela Laboratories
Dr Hiltrud Horn, Horn Pharmaceutical Consulting
Stephan Löw, CSL Behring
Dr Daniel Müller, GMP Inspector, German Local Government
Axel Schroeder, Concept Heidelberg

Learning Objectives

This Education 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.


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 are have to face the new and expected changes in the regulatory guidelines.

Target Group

This 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


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
  • Case Study
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
Process Validation in Clinical Phases I-III
  • Definition of Validation
  • Validation in early Clinical Phase
  • Validation in late Clinical Phase
  • Validation Documentation
  • Guidelines
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
Case Studies Hygienic GMP Deviations

  • 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: The Perspective Defines Contamination
  • Ways to Remove Contaminants: Cleaning Procedures and their testing
  • Risk Based Approach: Crucial Element of the Validation Programme

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