Former Head of the Pharmaceutical Inspection Dpt. AFSSAPS
Christof Langer
OSConsulting
Dr Eva Keller
Ferring
Dr Felix Kern
Merck Healthcare
Receive electronic copies of a Transfer SOP and a Transfer Master Plan.
Highlights
- Development of a regulatory Transfer Strategy
- Critical Quality Attributes to consider in Transfers of sterile and solid Dosage Forms
- Project Management & GMP-compliant Documentation of a Transfer
Target Group
This course addresses to staff from Production, Engineering, Quality Assurance, Regulatory Affairs and Project Management in charge of Transfer Projects. This involves Project Leaders and project team members, from receiving sites as well as from donor sites.
Objectives
Participants will learn how to plan and execute a successful, GMP-compliant process transfer across the product life cycle—from development and scale-up through commercial manufacturing and post-approval. The course focuses on the key success factors: defining a regulatory strategy, setting up effective cross-functional project management, and establishing robust, GMP-aligned documentation and written procedures for all transfer activities – as required for example, in Chapter 4 of the EU GMP guide.
The training addresses typical real-world challenges, such as incomplete process knowledge, demonstrating equivalence after transfer, and discrepancies between filed process descriptions and the actual process at the sending site—meaning that transfers often become product maintenance projects with significant time and cost implications. The course also provides practical guidance on regulatory expectations, structuring milestones and deliverables, managing changes during transfer, identifying critical quality attributes (including for sterile and oral solid dosage forms), and designing documentation that meets GMP expectations.
Programme
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
Further Information
GMP Transfer Templates All participants will receive helpful documents and templates via download, e.g.
Transfer SOP
Transfer Checklist
Transfer Master Plan
Technical Requirements
Our live online training courses and webinars are conducted using Webex. At www.gmp-compliance.org/training/online-training-technical-information you will find all necessary information for participation, including a system check to verify whether your IT environment meets the technical requirements. If the installation of browser extensions is restricted due to internal IT policies, please contact your IT department. Webex is widely used, and installation is straightforward.
Fees (per delegate, plus VAT) ECA Members 1.890 EUR APIC Members 1.990 EUR Non-ECA Members 2.090 EUR EU GMP Inspectorates 1.045 EUR The conference fee is payable in advance upon receipt of invoice.
Presentations/Certificate The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Conference language The official conference language will be English.
You cannot attend the Live Event? Many of the training courses and conferences are also available as recordings. You may watch these any time “on demand” on our web server. It is uncomplicated and doesn’t require any software – you simply watch the videos in your browser. All available recorded events can be found at www.gmp-compliance.org/recordings.
Testimonials
