Learn about the Background of CAPA to Understand why the FDA, EMEA and ISO9001
60 Minutes
Willi Ramseier
Overview
Following various incidents, the control mechanisms for medical devices - from heart valves to sticking plasters to artificial hips - are being tightened. Companies are asked to implement a product monitoring system that records product-specific complaints. Corrective Actions need to be taken as soon as a complaint is lodged, but also Preventive Actions against any recurrence and for their safe and good performance.The pharma industry has been operating in such rigid regulatory environment for years and the FDA continues to enforce a CAPA process.
The need for an CAPA process should not be an empty exercise in regulatory compliance but an integral part of the company's risk mitigation for the future product development, markets and sales.
There are many answers to the questions, what CAPA is. Most quality teams and consultancies have different ideas.
This webinar will give you the basic meaning of CAPA and a solid understanding of its background; the basis for your planning of the necessary processes for your company.
Why you should Attend
The cost of poor products or services can be staggering. Complaints, Medical Device Reports, recalls, and serious adverse impact to your customers are all results from poor quality management. A CAPA process is not a bureaucratic exercise but one of the very first processes to be implemented at the start of company. Not just companies in pharmaceutical or medical devices areas (including software providers for them) but any company with the aim, to produce high quality and very useful products.
Areas Covered in the Session
- Overview and Definitions
- The history of CAPA - you need to know the background to be able to use it
- Why should you use something like CA and PA
- Lessons learned (medical equipment)
- Common mistakes and todays problems
- Best practices - the ideal process
- When and how should you implement a CAPA process
Who Will Benefit
- Members within Drug and Medical Equipment Production
- Development and Logistic (working within Processes with no Tolerance for Nonconformities or Noncompliance)
- Process Owners
- Quality Assurance Teams
Speaker Profile
Willi Ramseier is a reputed trainer, mentor and a Quality compliance officer. He is an expert at Big Pharma company at Germany serving as Project and Process Guidance and Trainer being a Quality assurance and Compliance Officer.
Willi serves as a Process-Validation Expert at Synthes-dePuy-Johnston&Johnston Switzerland. Quality Consultant for a CRO in Cologne; providing hands-on help with process- documentation, requirements creation, planning, CSV (computerised system validation). CSV auditing He also involves himself completely in CAPA plan reviewing as a QA, and GxP Workshop Trainer for a CRO, Dresden
Willi aids the small companies on the new regulatory aspects. Mentoring the young quality-consultants, Start-ups companies. Early to his career as a consultant Willi has a good amount of management skills which certainly has helped him assisted him in all stages of his career so far.
Willi Ramseier’s areas of expertise: eClinical, eCRF, Data Management 21 PART 11, electronic records and signature Risk -awareness, -assessment, -management Risks and hazards at logistics of human samples and drugs CSV computerized system validation GxP, Quality Assurance, System/ Process Validation Creating and maintaining QMS quality management systems Data flow in clinical trials, Process management e.g.: DIA, cbi center for business intelligence, SMi Group, Arena-international, SAS Sweden, Roche -Global, -Basel, -Ireland.
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