Quality Course (04): Measuring and Documenting Quality, Risks, and Failures

2 day in-person, UoB (Venue TBC)

You’ll learn how to apply Quality by Design, identify key quality and process factors, and set up strong Quality Management Systems to ensure safe, consistent products.

Topics include writing SOPs and electronic batch records, getting ready for audits and inspections, and keeping good documentation. The course also covers how to spot and manage risks, find the root causes of failures, and use CAPA to prevent issues from happening again.

This Course Is Suitable For:

• Careers In: Quality Control, Quality Assurance, Manufacturing Personnel

• Scientists looking to broaden their knowledge of good manufacturing processes

• Graduates looking to prepare themselves for entering the advanced therapy and medicinal product industry

Learning Outcomes

• Corrective and preventive actions
• Root cause analysis
• Quality by Design
• CQAs and CPPs
• Documenting Quality
• Storage, security, compliance
• Quality Management Systems
• SOPs, (e)BMRs, Product Specifications

Workshops

Risks – what are the major risks

Failure – what, why, how to deal with it

Prices:

Free for UoB Staff/Students (register with UoB email address)

£495 for NHS Staff (you will be sent a link for payment separately)

£695 for Health Innovation West Midlands Staff (you will be sent a link for payment separately)

£995 for other external staff (you will be sent a link for payment separately)

Non-attendance policy:

We run our courses with funding from UK Government Department of Science, Innovation and Technology. We waive attendance fees in full for University of Birmingham staff and students; nevertheless, these spaces are highly valuable and should be treated as such. No-shows without prior cancellation are unacceptable, waste spaces and are inconsiderate to trainers. Therefore you must ensure you have permission from your PI/line manager to attend this course and in the event that you do not attend we will charge a non-attendance fee.