Effective Records Management and Document Control for Medical Devices

In this webinar attendees will learn the QSR and ISO 13485 requirements for document control and the ideas associated with the development and control of quality documentation. Also attendees will get knowledge on methods and practices that will improve the clarity and control of your document control system. Effective GMP documentation practices will be reviewed to ensure your paperwork is clear, complete, and easy to understand.

Learning Objectives:

  • QSR and ISO 13485 requirements for document control
  • Description of typical document control system in use
  • How to create uniform documentation that is easy to follow.
  • Establish systems that will speed up review of new or revised documents.
  • Streamlined document control process
  • Eliminate common formatting problems that create confusion.
  • Create more control over controlled documents in circulation.
  • Ensure obsolete documents are removed from use.
Areas Covered in the Session :

  • Establishing best practice SOP, Deviation, CAPA, Change Controls, Complaint and Audit processes
  • Conducting Risk Assessment, Root Cause Analysis and Impact Assessment where appropriate.
  • Creating Action Plans, and verifying their effectiveness.
  • Improving efficiencies over the QMS tasks
  • Reducing the risks of manual error
  • Ensuring compliance to 21 CFR Part 11 and immutable audit trail.
  • Avoid observations, 483 letters and fines
  • Taking the resource burden out of creating dashboards/ periodic reports
Who Should Attend:

  • Quality Assurance Departments
  • Research and Development Departments
  • Regulatory Affairs Departments
  • Manufacturing Departments
  • Engineering Departments
  • Operations Departments
  • Production Departments
  • Documentation Departments
  • Executive Management
  • Everyone involved with FDA compliance

MD2994

Denise Wrestler

Denise Wrestler, ASQ CQE, CQA; QA/RA Consultant at CYA Medical Device Consulting, LLC with almost 15 years of experience within FDA-regulated industries including medical device and pharmaceuticals, Ms. Wrestler provides quality, regulatory, and technical expertise to meet individual client needs. Ms. Wrestler agrees with the FDA’s “least burdensome approach” and prides herself on providing options and recommendations for ensuring regulations are met without wasting precious company resources.

Denise Wrestler holds a B.S. in Chemical Engineering with a Minor in Biomedical Engineering from the University of California, Irvine. Additionally, Ms. Wrestler holds ASQ Certifications as a Certified Quality Engineering (CQE) and Certified Quality Auditor (CQA). A contributing author to ASQ’s monthly publication Quality Progress magazine, Ms. Wrestler remains active within the quality and regulatory professional circles to ensure continuing education and awareness within the community. Ms. Wrestler has provided training, workshops, and presentations to small and large audiences alike on topics ranging from QSR, ISO 13485, auditing, and design control to risk management and regulatory readiness and preparation.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance
.