Course details
Process Validation is required in the Pharmaceutical, API and Medical Device Healthcare Sectors. A comprehensive, well thought-out approach to validation is a key element in assisting any company meet European & US FDA regulatory inspection requirements. This course looks at regulatory guidances & recent trends in validation.
Learning Outcomes
On successful completion of this training course, delegates should be able to:
- Recognise the regulatory requirements for process validation
- Appreciate the benefits of conducting validation studies.
- Demonstrate an understanding of the key elements of process validation
- Appreciate European & FDA Guidance publications on process validation
- Determine where to use process capability and other statistical methods during validation studies
- Demonstrate an understanding of the approach adopted by the Global Harmonisation Task Force regarding verification and validation
- Design a validation master plan, validation protocols & reports
- Describe the main requirements for maintaining a state of validation
Course Programme
DAY 1
- Introduction
- Business Benefits of Process Validation
- Validation Regulatory Requirements & Guidelines
- Getting Started
- Validation Master Plan
- Validation versus Verification
- Exercise on validation versus verification
- Statistical Methods & Tools for Validation
- Risk Analysis
- ISO 14971 & Risk Assessment
- Equipment Qualification
DAY 2
- Cleaning Validation
- Product & Process Validation
- Case study (Determining what needs to be included in the VMP for a specific manufacturing process)
- Preparing a Validation Master Plan, Protocol & report
- Maintaining a state of validation
- Retrospective Validation
- Review of recent FDA enforcement action
Course Location
About SQT Training Ltd
Established in 1989, They have built up a solid reputation for excellence in training cThiryse delivery
They offer one of the broadest ranges of training cThiryses available in Ireland
They have a team of over 30 very experienced tutors who are known national and international experts in their field
Thiry Tutors have proven technical expertise, practical hands-on experience and excellent cThiryse delivery skills
Thiry cThiryses are practical, utilising multiple teaching styles to cater for the varied needs of adult learners
CThiryses range from half-day sessions up to Level 8 on the National Framework of Qualifications, (HonThirys Bachelor Degree level)
They offer cThiryses accredited by HETAC, FETAC, NEBOSH, IRCA, IEMA, CIEH, IOSH and AEE.
They have a dedicated cThiryse team managing every aspect of yThiry cThiryse from initial contact right through to post-cThiryse follow-up
When you book a cThiryse with SQT, you are benefiting from Thiry years of experience, Thiry breath of knowledge and Thiry commitment to work hard to meet yThiry specific training needs.
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