Effective Records Management & Document Control for Medical Devices

Duration: 60 Minutes
Even the smallest of changes often requires an excessive amount of time to prepare submit, distribute, and implement change requests, document modifications, document review meetings, document approvals, and document placement. This webinar will review the QSR and ISO requirements for document control, and provide a streamlined process for document control. We will discuss 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.
Document Control for Medical Devices
Instructor: Denise Wrestler
Product ID: 506540
Objectives of the Presentation
The document management system for medical device industry should help companies have control over critical activities such as:
  • 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
Why Should you Attend
  • Do you have unapproved or outdated documents in circulation?
  • Are your SOP revisions being done in an uncontrolled or inefficient manner?
  • Does your production team use confusing formats that create uncertainty in record-keeping?
In the Medical Device industry, companies must "establish and maintain" documents, procedures, and records. This can involve huge numbers of documents. Without a system for control, this can quickly become burdensome and out of control. This can have disastrous consequences in an FDA inspection.

This webinar will examine the ideas associated with the development and control of quality documentation.

Areas Covered
  • 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
Who will Benefit
This webinar will provide valuable assistance to all regulated companies, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:
  • Document control personnel
  • QA managers and personnel
  • Quality control personnel
  • Facility maintenance and calibration personnel
  • Manufacturing and operations personnel
  • Any employee involved in regulatory audits
  • Executive Management
  • Document Control Clerks
  • Consultants
  • Quality system auditors
$375
Recorded Session for one participant
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How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
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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