Roadmap to ISO Certification:
Internal Audit, CAPA & Management Review – FX Audio Conference – November 19, 2013 – 11:30am-12:30pm
Internal auditing, CAPA and Management Review are considered the three most important processes in a Quality Management System (QMS). This presentation focuses on the final stages of getting ready for your ISO certification audit. The first process, internal auditing, is conducted and should identify any problems in the QMS. A proper audit will include all the requirements of the ISO 13485 as well as the applicable regulatory requirements.
Once internal audits have identified problems, your CAPA process is used to prevent problems from recurring and to prevent potential problems from occurring within the QMS. The key to proper corrective action is identification of the root cause of those problems. Proper verification of the effectiveness of these actions is the key to preventing them from recurring.
The last task to complete before your certification process begins is to conduct a management review. Conducting management reviews is critical to communication throughout the organization, and management reviews ensure that adequate resources are available to maintain the continued effectiveness of the QMS.
Internal Audit, CAPA & Management Review
Join us for this informative audio conference presentation, as our speakers prepare you for your initial ISO certification audit!
This audio conference covers:
- Internal auditing of regulatory requirements within your QMS
- Preparing for your Notified Body initial audit through CAPA and Management Reviews
- Attendees will have the opportunity to purchase a separate breakout session after the conference
About the speakers:
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.
Susan Christie has more than 30 years of experience in quality and regulatory affairs for medical device and pharmaceutical products. She has experience with 510(k) and CE Marking Submissions. She is an expert in complaint handling and helping clients interact with the FDA on compliance issues. She is a certified Lead Auditor and she was the Lead Audit Program Manager for a multi-site device/drug manufacturer. Her focus is on strategic development and quality system best practices. She is currently working with Rob Packard to develop a Design Dossier training program especially for spinal implant companies. You may contact Susan directly by email at: firstname.lastname@example.org.
Who should attend?
- Quality Assurance
- Regulatory Affairs
Discounted Cost & Registration: Normally FX Conferences charges $259.00 but with the Medical Device Academy special discount you pay $209.00 (you can also get transcripts & recordings & other options). When checking out use the $50.00 discount code fxtpc13.
Other events in the Roadmap to ISO 13485 Certification series:
- Planning the Quality Management System
- Additional Regulatory Requirements for the US, EU and Canada
- Design Controls
- Training & Documentation Control
- Stage 1, Stage 2 & Responding to Findings
- Purchase all six events and save over 50%!
Plus – Roadmap to ISO 13485 Certification – The Series – Break Out Sessions
After each presentation, the speakers will be hosting optional online break-out sessions to facilitate further discussion and to answer company-specific questions. Further details regarding these sessions will be provided to registrants along with the presentation materials for each event.