Effective Records Management & Document Control for Medical Devices
Register for this event
- DateTue 05 November 2019
- Time10:00 AM - 11:00 AM
- Location39658 Mission Boulevard, Fremont, CA 94539, USA Fremont National 9453
- Ticket$$ 110 per person
- Table$Price for a table per table (seats Normally between 8-12)
- ContactEvent Manager
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Do you have unapproved or outdated documents in circulation?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
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.