A risk-based CAPA process is a common goal of medical device manufacturers, but until recently “risk-based” was not clearly defined. The two quality management system standards, ISO 9001 and ISO 13485, are being revised. ISO 9001:2015 is expected to be re-issued in October 2015 and ISO 13485:2016 is expected to be released in Q1 of 2016. The biggest fundamental change in both standards is an emphasis on risk-based process management. The CAPA process is the heart of your quality system and one of the most important processes. Therefore, this presentation gives you a whole new set of tools for managing your CAPA process using risk-based approach.
A risk-based CAPA process is more than prioritization
This webinar goes beyond simple prioritization of CAPAs and color-coding of CAPAs as high, medium and low risks. Instead, Rob Packard reviews best practices in risk management (i.e., ISO 14971) and he applies the more rigorous risk management process to the CAPA process.
This is a “must-see” presentation for anyone that is responsible for the CAPA process or participates in their company’s CAPA Board. Join us for this webinar presentation as our speaker helps you integrate risk management activities with your CAPA process.
This risk-based CAPA webinar includes:
- Revised requirements for ISO 9001:2015 (DIS2) and ISO 13485:2015 (DIS2)
- An outline of the CAPA process and proposed risk management activities
- Various risk control options that can be integrated with corrective actions
- How to reconcile conflicts between the definitions for risk in ISO 9001 and ISO 13485 in the 2015 versions
This webinar recording is only $129 (AND INCLUDES NATIVE SLIDE POWERPOINT PRESENTATION FILES):
How to Create a Risk-Based CAPA Process. This webinar includes the most recent updates to ISO 13485:2015 (DIS2), ISO 9001:2015 (DIS2) and EN ISO 14971:2012.
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
Rob Packard is a regulatory consultant with ~25 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.