Technology Transfer in the pharmaceutical

09:00 – 13:30 COURSE SESSION

1. 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)

2. EU GMP Pt.I Chapter 7:

• Principles
• General Activities
• Contract Giver and Contract Acceptor: GMP Roles and Responsibilities

3. Cross-references with Annex 15, ICH Q9

4. Cross-references with the objectives of the ICH Q10-Quality System model:

• Knowledge management
• Continual Improvement

5. 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

6. 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

7. 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

8. 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

9. Workshop – Final Session

• • Case studies
  • Key factors for fully capturing the objectives of technology transfer
  • Q&A

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.

Cancellation terms

In order to cancel enrolment to an event, please email info@pharmaeducationcenter.it within 2 weeks before the starting date of the event. Once this term will be expired, the entire fee will be charged.

Participant replacement

It is possible to replace a participant attendance without additional cost, simply by contacting info@pharmaeducationcenter.it. 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.

Training cancellation

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.