Corrective Action Planning
Corrective Action Planning
English | Intermediate Level | Pharma and Medical Device | Presentation | 1 hour and 24 minutes
Corresponds to ½ day of teacher-directed learning
Description
Learn about the three keys to successful CAPA planning and how each of these supports carrying out meaningful QMS improvements. CAPA is an essential Quality Management System pillar - make every CAPA count!
Content
- Context: Corrective and Preventive Action in the QMS
- CAPA planning: Regulatory requirements for CAPA planning
- CAPA planning: Three keys to successful CAPA plans
- Examples of successful CAPA plans
Course module
1. Corrective Action Planning
Learn about the three keys to successful CAPA planning and how each of these supports carrying out meaningful QMS improvements. CAPA is an essential Quality Management System pillar - make every CAPA count!
Trainer: Tammy M. Pelnik
Duration: 1 hour and 24 minutes (Total duration of the course: 1 hour and 24 minutes)
Course material
There is no additional course material for this course.
Notes
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Training organisation
Key2Compliance AB
Key2Compliance AB is an independent international organization providing its training and services to a variety of functions in the Life Science industry, from development to market in terms of Quality Systems and Regulatory compliance.
By helping organizations to comply with regulatory expectations, to enhance workforce knowledge and motivation and to promote a correct attitude towards quality, we believe we contribute to the supply of safe health care products - and in a wider perspective we save lives.
Trainer
Tammy M. Pelnik
Tammy Pelnik is an industry expert, a quality systems consultant and President of The St. Vrain Group, Inc., a management and technology consulting firm. Ms. Pelnik is noted for her subject matter knowledge, expertise in presenting engaging courses, and her frank, direct approach to addressing attendee questions throughout each class.
Ms. Pelnik is an ASQ Certified Quality Manager and Certified Quality Engineer, IRCA QMS Principal Auditor and holds a MS degree in computer science. Ms. Pelnik is on AAMI’s Board of Directors and has been a member of the AAMI faculty for many years. She has served on the Biomedical Instrumentation and Technology Editorial Board, the Regulatory Affairs Professionals’ Rocky Mountain Chapter steering committee and the ASQ Boulder Section’s leadership team. She has published articles in Regulatory Affairs Focus, Medical Device and Diagnostic Industry, Software Quality Journal, Biomedical Instrumentation & Technology and numerous conference proceedings.
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