CAPA / RCA / Investigations Training Course (T73)
Coming Soon 2024
Overview
CAPA and Continuous Improvement using Process Performance & Product Quality Monitoring (PPPQMS), are elements of the Pharmaceutical Quality System (PQS), supported by ICH Q10. By practicing effective CAPA and PPPQMS a Pharmaceutical Quality System can realize Quality Management Maturity. Through lecture and “hands-on” team exercises this course illustrates how a mature Pharmaceutical Quality System utilizes CAPA and Continuous Improvement, how to effectively write and investigate to achieve holistic CAPA, and what PPPQMS can do for your PQS.
Learning Objectives:
ICH Q10, ICH Q7, 21CFR 211 regulatory framework and linkage to the Pharmaceutical Quality System
Understanding the importance of how CAPA and Continuous Improvement integrate with the Pharmaceutical Quality System
Understanding Quality System Management Maturity
- Where and how does Management Responsibility fit in
- What are the enablers of a Pharmaceutical Quality System and how they work
How to Perform Holistic and Effective Correction and CAPA
- Effective Deviation Authoring
- Investigation for True Root Cause
- Correction and CAPA
Product Performance and Product Quality Monitoring System (PPPQMS)
- Product & Process Understanding & Tools
- Monitoring and Continual Improvement
What You Will Learn
- To author an effective investigation
- Perform holistic correction and CAPA
- Reduce deviations through risk based continuous improvement
Resources and Activities
- Pre-Course Work Materials
- Interactive Exercises
- Learning Assessments
- APQ Guide: Corrective Action & Preventive Action (CAPA) System
- APQ Guide: Cultural Excellence
- APQ Guide: Management Responsibilities & Review (MRR)
- PQLI Guide: Part 4 - Process Performance & Product Quality Monitoring System
Who Should Attend
- Quality Assurance
- Tech Support
- Tech transfer functions
- Operations functions
- Early career (3-5 years within the industry)
- Qualified persons in Europe
- Team Lead/Operator/Technician Staff
- Managers
- Section heads
- Supervisors and CEOs
- President
- Owner or General Manager working in pharmaceutical and biotech manufacturing (not CMO)
- Engineering
- Architecture or construction
- Service provider or consulting
- Equipment or material supplier
Additional Course Information
Communities of Practice
This training course is of particular interest to existing and future members of the Regulatory and Quality Networking Communities.
Daily Schedule and Pricing
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Online Live20 - 21 Mar 2024Daily Schedule at a Glance
Training course times are listed in Central European Time (CET). Find your personal viewing time on the World Clock.
0830 – 0845 Login 0845 - 0900 Introductions 0900 - 1030 Course Content & Exercise 1030 - 1045 Break 1045 - 1215 Course Content & Exercise 1215 - 1300 Lunch 1300 - 1430 Course Content & Exercise 1430 - 1445 Break 1445 - 1615 Course Content & Exercise 1615 - 1630 Wrap-up, Questions, Discussion 0830 – 0845 Login 0845 - 0900 Recap 0900 - 1030 Course Content & Exercise 1030 - 1045 Break 1045 - 1215 Course Content & Exercise 1215 - 1300 Lunch 1300 - 1430 Course Content & Exercise 1430 - 1445 Break 1445 - 1615 Course Content & Exercise 1615 - 1630 Wrap-up, Questions, Discussion Registration Fee
REGULAR*ISPE Membership is required for these registration rates.
Now Your Whole Team Can Participate in an ISPE Learning Experience
- 3 - 5 participants - Save 10%
- 6 - or more participants - Save 20%
Group discount applies to Member/Nonmember rate only. To qualify, all registrant information must be submitted at the same time. Registrations that arrive later will NOT be eligible for the group discount. Cannot be combined with other offers. To register as a group, please contact ISPE by telephone, +1-813-960-2105 or by email, ask@ispe.org.
Cancellations/Refunds
Cancellations must be made in writing. If cancellations are received by 60 days prior to event start date, a full refund, minus a $150 handling fee, will be issued. After that time, no refunds will be granted. Please be advised that if your payment or written cancellation notice is not received prior to the cancellation date, your credit card will be charged the prevailing rate. Refund requests must be in writing and emailed or faxed to +1 (813)-264-2816. (Telephone messages are not accepted). ISPE reserves the right to modify the material or presenters for this event without notice, or cancel an event. If an event must be canceled, registrants will be notified by ISPE. ISPE will not be responsible for airfare penalties or other costs incurred due to cancellation.