GMP Compliance for Biopharmaceuticals

GMP  Compliance for Biopharmaceuticals

Heidelberg, Germany

Course No 15198


Costs

This conference already took place.

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

Speakers

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

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.

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 found particular challenges to fulfil the regulatory requirements on production and quality assurance. Industry and authorities are treated with 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

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
Dr Daniel Müller

GMP Guidelines for Biopharmaceuticals – a brief
summary
Relevant international regulations
European biotech guidances
Recent developments & possible impacts
Dr Daniel Müller

Development of Biopharmaceuticals - GMP and
Regulatory Aspects
GMP and Regulatory Documents
Ways to Success
Interaction with Authorities (Meetings/Inspections)
Dr Hiltrud Horn

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
Markus Fido

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
Dr Daniel Müller

GMP-conform process development and qualification (including equipment qualification)
Current Regulatory Initiatives
ICH Q8 / ICH Q9
Process Development Approaches
Design Space / Analytical Methods
Equipment Qualification for Development Studies
Markus Fido

Case Study: Process Transfer from Development to commercial Production
Key Aspects for EU and US
Difference between Development and Commercial Production
Case Study
Dr Hiltrud Horn
Quality Assurance for Biopharmaceuticals
Classical responsibilities of QA dept.
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
Dr Daniel Müller

Process Validation in Clinical Phases I-III
Definition of Validation
Validation in early Clinical Phase
Validation in late Clinical Phase
Validation Documentation
Guidelines
Markus Fido

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
Stephan Löw

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
Stephan Löw

Workshop: Case Studies Hygienic GMP Deviations
Examples of Pitfalls
Chemical Interactions
Human Errors
Incorrect use
Axel Schroeder

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
Dr Daniel Müller and Stephan Löw

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