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- Do you have unapproved or outdated documents in circulation?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 in the Session
- 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
- Quality System Auditors
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.