Overview
This programme is designed for technical, quality assurance, production, engineering and validation personnel who are responsible for the preparation, control or implementation of validation plans.
This course is designed to provide participants with the latest information and validation requirements of the MHRA (UK) and FDA ( United States ).
Participants will develop skills in designing and preparing specific validation plans and protocols.
Key Subject Areas
- Principles of Validation
- Regulatory Approach to Risk Management – current and future trends
- Validation Master Plans
- Qualification and Commissioning
- Process Validation and Protocols
- Cleaning Validation Rationales & Acceptance Criteria
Course Outcomes
On completion of the course, participants will be able to:
- Explain the importance of planning for validation
- Use tools to determine key process variables
- Prepare validation plans
- Prepare validation protocols
- Participate in validation programmes
Duration
This is a two-day programme.
Course Format
The course uses a balanced mix of presentations, case studies, exercises and interactive discussions.
Wherever possible examples taken from, or directly relevant to, the organisation are used to illustrate the principles.
Central to the training is the development of the client's project process as a means of linking the theory and regulatory requirements for validation with the work practices of the delegates.
Delegates will be divided into syndicates to develop draft plans and protocols for specific validation activities.
A short quiz will be used at the end of the course to confirm understanding of the subject.
Customisation
This course will be customised by SeerPharma to ensure a good fit with organisational needs.
Where possible, the client will be asked to provide details of specific activities or projects.
Presenters
SeerPharma will lead the course and facilitate the group activities.
The presenters are all experienced in pharmaceutical management, quality assurance, process analysis & improvement and validation
Course Materials
Each delegate will receive a copy of the overheads, case studies, exercises and notes.
Each delegate will be presented with a certificate showing that they have successfully completed the course.
To request further information on this course or to reserve a place (with no obligation) please contact us using the details below:
PO Box 3255,
Littlehampton,
BN17 9AD
Tel: 01903 730 622
e-mail: debra.stanfield@seerpharma.co.uk
