Quality Records Documentation Issues

Medical device companies often have a hybrid mix of record-keeping that does not serve the firm well in providing a coherent presentation to regulatory agencies. Quality records are often overlooked when setting up a robust quality documentation system. Integration of 21 CFR Part 11 for many smaller companies is deficient.

This presentation is designed to provide pertinent information for management at all levels to understand the record-keeping requirement of the 21 CFR Part 820 and the impact of failing to implement 21 CFR Part 11 in accordance with both regulations.

Areas Covered in the Session :

• Documentation of recordkeeping
• Predicate rule and the impact of 21 CFR Part 11
• Concerns related to legacy systems and Part 11
• Consideration of the FDA comments in the Final Rule of the Quality System Regulation
• A review of pertinent Warning Letters and the Agency comments contained therein
• Interactive Q&A Session

Who Should Attend:

• Process Development Teams
• Manufacturing Teams
• Documentation Departments
• Clinical Investigators
• Contract Manufacturers
• Quality Department
• Corporate officers who control financial decision over the Quality System
• Corporate officers who manage the Quality Systems including Management Representatives
• Line Supervisors
• Firms that have regulatory issues already or are attempting to upgrade their recordkeeping
• For Live – How it works:
• Login Information with Password to join the session, 24 hours prior to the webinar
• Presentation Handout in .pdf format
• Presentation from the Speaker
• Q&A session with the Speaker
• Feedback form
• Certificate of Attendance

Course Director: RICK RUTHERFORD

Rick Rutherford served as an FDA Investigator for twenty-four years and was a device and biologic certified level II investigator (one of only a handful of investigators Agency wide certified at Level II in more than one program). He served as a Performance Auditor/Trainer for the Agency’s Level II internal certification of investigators and for the Accredited Persons third-party program. He was a device expert for the last several years and served in the International Inspection Cadre. His experience includes greater than 120 international medical device inspections. Since retiring from the US Public Health Service Commissioned Corps and the US Food and Drug Administration, Rick has been active, as a consultant to medical device firms in the US and internationally, performing mock FDA audits, providing training, webinars and consultation on remediation following FDA 483 citations, Warning Letters and consent decrees issued by the FDA. He has a B.S. in Biology and has been trained in 36 training courses in the full range of FDA regulatory coverage. His experience also includes being a US Navy Hospital Corpsman with hands-on patient care, environmental health issues and has worked in the Oklahoma State Department of Health.