- Datum:
-
- Webinar
Product Transfer - Live Online Training
- Veranstaltungsort:
- online
- Veranstalter:
- CONCEPT HEIDELBERG GmbH
Fundamentals of Technology Transfer
- Various types of transfer
- Regulation and GMP challenges for Technology Transfer
- Identifying key elements of Technology Transfer
- What to consider when planning a Technology Transfer
- How to set acceptance criteria for a successful Transfer
Regulatory Affairs for Production Transfers
- Regulatory planning and strategy for production site Transfers (development projects and approved products)
- Complex global regulatory environment (country specific requirements, approval timelines, change categories and transition rules) in the context of production site Transfers
- Particulars for NCEs and NBEs in the context of production site Transfers
- Success factors for efficient regulatory management and execution of production site Transfers
Technological Aspects: Transfer of Oral Solid Dosage Forms
- Basic Requirements
- Identification of critical quality Attributes
- Risk assessment and risk Mitigation
- Scale up strategies for granulation and tableting
- How to deal with different types of equipment?
- Examples
Sterile Manufacturing Site Change - Process Characteristics
- Comparison of equipment and clean rooms / barrier systems of sending and receiving unit
- Critical quality parameters of product and process
- How to establish comparability criteria
- What is fixed and what can be changed: packaging material, process parameters, equipment, ... (?)
- Frequent failures & trouble Shooting
Production Transfers - Case studies including do’s and don’ts from a regulatory perspective
- Case study: production transfer during development (from development to commercial launch sites)
- Case study: production transfer for an approved product
- Typical health authority questions including do’s & don’t from a regulatory perspective
Case Study Ferring: Transfer of an (aseptic lyophilized) US product between European sites
- Scope of the Site Change
- Project Plan, Project Phases and Timelines
- Documentation of the Transfer
- Regulatory Strategy (US)
- Unforeseen gaps
- Project Reporting
Project Management
- Setting up the project and the Transfer Team
- Project Plan and Transfer Master Plan: how to document the transfer activities
- Monitoring of the transfer activities
- Definition of milestones and time Management
- Pre-evaluation and feasibility phase, preparatory phase, Project completion phase
GMP-compliant Documentation & Finalisation
- Defining documentation required pre & post Transfer
- Roles and responsibilities of parties in preparation, review and approval of documentation
- Reporting of transfer findings and change Control
- How to manage the transition period (e.g. first few batches!)
- Document check list
CONCEPT HEIDELBERG GmbH
Rischerstraße 8
69123 Heidelberg
Deutschland
Telefon: +49 6221 844415
Telefax: +49 6221 844464
eMail: info@concept-heidelberg.de
Internet: http://www.gmp-navigator.com/
