Good Automated Manufacturing Practice (GAMP) (CESPE Academy)

Description

Interested in expanding your knowledge of Good Automated Manufacturing Practice (GAMP), Computerized System Validation, Regulations, and more? Experts from QbD Group will be instructing a 2-day training that will do exactly that. Check the information on the course below to decide if it suits your needs!

Production systems for the pharmaceutical and food industries have to comply with ever-stricter legislation. This training not only offers you theoretical knowledge of the basic aspects of GAMP – with a focus on the detailed life cycle – but also offers multiple practical exercises. Additionally, a test will be provided so that you can check if you can apply your gained knowledge.

The course begins with an introduction to GAMP principles and gradually builds to more complex examples and exercises.

The target audience are professionals or students in chemical, pharmaceutical & healthcare sciences and engineering.

• No prior knowledge needed
• Practical learning approach
• Ideal for more in-depth practitioners, who want to get more examples and use cases included as part of the training

Program

Link to Course Programme

Planning Day 1

• Introduction to GAMP
  • The lifecycle phases
  • GAMP categories
  • Key principles
• Detailed lifecycle
  • Planning specification configuration and/or coding
• Regulations
  • 21 Cfr part 11
  • Annex 11
• Extended exercises on
  • Validation plan
  • User requirements specifications
  • Functional specifications
  • Risk assessment
  • Test scripts

Planning Day 2

• Detailed lifecycle
  • Verification reporting
• Operational phase
• Extended exercises on
  • Test execution
  • Test report
  • Validation reporting
  • Requirements traceability matrix
• Test for course participants

Remarks

Additional information

• One week prior to the course, the registered participants will receive further information (directions, parking availabilities, course material).
• Upon completion of the training, a certificate of attendance will be made available on the platform.
• Additionally, the participant will receive an evaluation form to provide feedback on this training.
• By registering for this course, the participants consent to the sharing of their name and email information with the course instructor/provider for the purposes of sharing educational course-related information.

Annullation/Cancellation

Registration is possible up to one week before the day of the respective session.
Registrations can only be cancelled by email. In case the cancellation occurs later than two weeks before, but earlier than one week before the start of the course, half of the registration fee will still be due. In case of cancellation less than one week before the start of the course the full registration fee will still be due. For UGent PhD students, the price of the registration fees for the Academic (UGent postdoc or professor) category will be considered when calculating the cancellations fees, meaning cancellations later than two weeks before the course will carry a fee of 210.- EUR and cancellations later than one week before the course will carry a fee of 420.- EUR.

The organization reserves the right to reschedule or cancel the training in case of insufficient number of participants.

Pricing

• Industry (non CESPE member): 1500.- EUR
• Industry (CESPE member): 1050.- EUR
• Academic (non-UGent): 600.- EUR
• Academic (UGent postdoc or professor): 420.- EUR
• Academic (UGent PhD student): Free of charge