CAPA is the heart of the Quality Management System (QMS) and indicates how effective the QMS is. In this 50+ minute webinar, Rob Packard, subject matter expert, and founder of Medical Device Academy, presents a number of proven methods to help improve your company’s CAPA process, including:
- Root Cause Analysis Tools
- 5 Why Analysis
- Is/Is Not Analysis
- Fishbone diagrams
- Pareto analysis
- Effectiveness checks
- Sources of corrective and preventive actions
- Pareto analysis of service issues
- Trending CAPAs, average aging of CAPAs, “Death by CAPA”
- Risk Management: risk-based CAPAs, risk thresholds, 7 criterion for estimating risk
- Documenting CAPAs
- 8 steps to writing an effective CAPA SOP
- Auditing the CAPA process
- Problem-solving A3
- Key elements of CAPA forms
This webinar recording is only $129 (AND INCLUDES NATIVE SLIDE POWERPOINT PRESENTATION FILES):
How to Improve Your CAPA Process recorded webinar provides step-by-step advice for completing CAPAs on-time, and validating the effectiveness of actions taken.
20- Question Exam and Training Certificate available for $49.00:
This is a 10 question quiz with multiple choice and fill in the blank questions. The completed quiz is to be submitted by email to Rob Packard as an MS Word document. Rob will provide a corrected exam with explanations for incorrect answers and a training effectiveness certificate for grades of 70% or higher.
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About Your Instructor
Robert Packard is a regulatory consultant with 20 years experience in the medical device, pharmaceutical and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Robert was a senior manager at several medical device companies—including President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certification. From 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Robert’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications and 510(k) submissions. The most favorite part of his job is training others. Specialties: CE Marking, Canadian Medical Device Applications, Post-Marketing Activities, Supplier Quality, CAPA, Risk Management, Auditing, Sterilization Validation, Lean Manufacturing, Silicone Chemistry, Extrusion, Bioprocess Engineering, and Strategy. He can be reached via phone 802.258.1881 or email. You can also follow him on Google+, LinkedIn or Twitter.