Successfully transferring products and processes in the pharmaceutical industry, whether from the development phase to the industrial phase or within or between different production sites, must be based on the awareness of the absolute importance of knowledge sharing among the Parties involved. Such sharing forms the basis for successively approaching effective change management, production processes, and validation and control strategies always considering continuous improvement as the cornerstone. The training course “Guide to Technology Transfer” aims to first provide references to guidelines that enable awareness of roles and responsibilities in the technology transfer process. It will then delve into the links between change management, process performance, and systems for monitoring the expected quality of the final product that will facilitate the achievement of the objectives inherent in the process itself.
The delegate will then gain knowledge of the responsibilities according to the roles but above all will become familiar with the building blocks of the pharmaceutical quality system to be considered. “Case studies” and situations from real experiences will be used in the course.
Key points of the training
- Consider the fundamental importance of knowledge sharing in technology transfer
- Tie knowledge transfer to other supporting elements of Pharmaceutical Quality System management
- Broaden knowledge of the tools to be used to identify approaches and strategies
- Know which are the pivotal documents for each process step
09:00 – 13:30 COURSE SESSION
- Overview of the guidelines:
- EU GMP Pt.I Chapter 7
- EU GMP Annex 15 (Qualification and Validation)
- ICH Q9 (Quality Risk Management)
- ICHQ10 (Quality System model)
- EU GMP Pt.I Chapter 7:
- General Activities
- Contract Giver and Contract Acceptor: GMP Roles and Responsibilities
- Cross-references with Annex 15, ICH Q9
- Cross-references with the objectives of the ICH Q10-Quality System model:
- Knowledge management
- Continual Improvement
- Outsourced activities – General requirements, preliminary activities
- Contracts and Agreements
- Knowledge management between Contract Giver and Contract Acceptor:
- Gap analysis
- Risk management
- Change management
- The Technology transfer protocol
- Contract Giver – Role and Responsibilities
- Information exchange.
- Assisting the “Contract Acceptor” in the preliminary assessment stages, regarding:
- Quality risk assessment
- Change control management
- Process performance and product quality monitoring
- Contract Acceptor – Role and Responsibilities (“Pillars” ICH Q10)
- Process performance and product quality monitoring
- Application of an effective CAPA System (Corrective Actions and Preventive Actions)
- Application of an effective Change Management System
- Continuous improvement by monitoring internal and external factors
- Common goals during technology transfer steps.
- Regulatory gap analysis
- Technology transfer protocol
- Approach to Analytical transfer/Method validation
- Approach to Process validation
- Management of change and internal factors (ex: Deviations)
- Continuous performance and product quality monitoring
- Performance/Quality metrics and periodic review
- Workshop – Final Session
- Case studies
- Key factors for fully capturing the objectives of technology transfer
Personnel involved in the various phases of the technology transfer process as “Transfer Giver” and “Acceptor”: Pharmaceutical Development, Production and Quality Control Managers, Quality Assurance Specialists/Managers, Regulatory Affairs Managers and Specialists /Process Engineering Manager.
The course will be carried out through live lectures. Practical examples will be showcased, providing delegates with real life examples to be applied in their daily job life.
For online trainings the access link will be sent 2-3 days before the start of the training.
5% discount for registrations within 1 month before the start of the training, 10% discount for registrations within 2 months before the start of the training. VAT not included. Please inquire for discounts for multiple registrations. Discounts are not cumulative.
In order to cancel enrolment to an event, please email email@example.com within 2 weeks before the starting date of the event. Once this term will be expired, the entire fee will be charged.
It is possible to replace a participant attendance without additional cost, simply by contacting firstname.lastname@example.org. It is asked to notify the participant replacement request within 5 days before the starting date of the course/event, specifying the full name and surname of the enrolled participant as well as the full name and surname of the substitute.
If the minimum number of participants is not reached, Pharma Education Center reserves the right to cancel or schedule the event for another date. Formal communication will be given within 5 days before the event date. In this case Pharma Education Center will refund the registration fee in full and without additional charges. Alternatively, the participant can request a spendable coupon for participating in another PEC event scheduled in the current year.
Experienced Advisor in Industrial Pharmaceutical Technologies and Quality System management / Qualified Person and Lead Auditor
Stefano Scorsini has a solid experience of over 30 years in the GMP of pharmaceutical operations in various positions of responsibility (Head of Manufacturing Departments, Production Manager, Manufacturing site Director), completed by the appointment first as Technical Director in Italy (1992-2004) and subsequently as Qualified Person EU and MHRA in various pharmaceutical companies. Scorsini has consolidated in-depth experience in different areas such as: Quality System Management in its various areas (Changes, Complaints, Deviations / Investigations, Risk assessment, APQRs), GMP/GDP auditing processes (Lead Auditor since 2014), GMP flows in pharmaceutical operations, technology transfer project management, management of equipment and related utilities associated with processes and management of ERP systems start-up, from the design and definition of User Requirement Specifications to the respective qualification phases and validate.
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