Sprecher
GMP Compliance for Biopharmaceuticals
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
GMP for Advanced Therapy Medicinal Products (ATMP)
Dr Rainer Gnibl, Government of Upper Bavaria
Dr Andrea Hauser, Jose-Carreras Center, University Hospital Regensburg
Dr Hiltrud Horn, Horn Pharmaceutical Consulting
Jan-Oliver Karo, PEI, German Federal Agency for Vaccines and Biomedicines
Dr Ralf Sanzenbacher, Paul-Ehrlich-Institut; German Federal Agency for Vaccines and Biomedicines
Niina Taylor, Pfizer
Programm
GMP Compliance for Biopharmaceuticals
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
- Relevant international regulations
- European biotech guidances
- Recent developments & possible impacts
- GMP and Regulatory Documents
- Ways to Success
- Interaction with Authorities (Meetings/Inspections)
- Relevant Guidelines
- Phases of Product Development / Testing
- Requirements
- Method Portfolio/Method Development / Method Qualification / Method Validation
- 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
- Key-Aspects for EU and US
- Difference between Development and Commercial Production
- Case Study
- 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
- Definition of Validation
- Validation in early Clinical Phase
- Validation in late Clinical Phase
- Validation Documentation
- Guidelines
- Reasons for cell banking
- Where does GMP start
- Characterization of cell banks
- Storage of cell banks
- 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
- 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
GMP for Advanced Therapy Medicinal Products (ATMP)
Tissues, Tissue Preparations and ATMPs: Introduction
- Overview on Products and Therapies: Reality and Future
- Legal Framework in EU and Germany
- CTA, Hospital Exemption and Marketing Authorisation: Steps to Consider in the Development of ATMPs
- Guideline Overview
- ATMPs & Quality Risk Management
- Zone-Concept for ATMP Facility
- Focus: Qualification & Monitoring
- Focus: Process-Validation & Media Fill
- Focus: Documentation
- How to certify/release an ATMP Batch
- Specific Products/Processes
- Essential Effects of the New Guideline
- Challenges in Practice
- US Requirements
- Starting materials for ATMPs
- Raw/ancillary materials for production
- Specifics for process validation and quality control of ATMPs
- Responsibilities of the QP - what is different for ATMPs
- Important Aspects for Characterisation and Control
- Quality of Reagents and Materials
- Relevant guidance documents
- Inspection Experiences and Findings
- Common Deficiencies in Clinical Trial Applications
- Installation of a clean room facility for manufacture of ATMPs in an academic setting
- Establishment and validation of the manufacturing process with special focus on GMP-compliant FACS sorting
- Application for a phase I/II investigator initiated clinical trial
- Challenges in aseptic manufacturing
- Dealing with research grade raw materials in a cGMP environment
- Dealing with Contract Manufacturing organisations
- Specific cGMP challenges and possible solutions
- Challenges and Critical Aspects
- Relevant Guidance Documents
- Modern Microbiological Safety Concepts
- Case Studies from Microbiological Assessment
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