Effective Records Management and Document Control for Medical Devices

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Do you have unapproved or outdated documents in circulation?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.

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.

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 Webinar:

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

Who Will Benefit:

• Regulatory professionals
• Quality Assurance professionals
• Executive Management
• Individuals involved with FDA compliance

Denise Wrestler
QA and RA Consultant , CYA Medical Device Consulting LLC

With over 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) as well as lead auditor certification for ISO 13485. 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.

CYA Medical Device Consulting provides services to individual clients as well as companies ranging from 10 to 1,000 employees.

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