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Who should attend Effective Records Management & Document Control for Medical Devices
This webinar will provide valuable assistance to all regulated companies, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields
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Effective Records Management & Document Control for Medical Devices  

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This webinar will provide valuable assistance to all regulated companies, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields

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Seminar Summary:

This webinar will review the QSR and ISO requirements for document control, and provide a streamlined process for document control. (see full course description)

 
 

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Training Course Syllabus:


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.

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Do you have unapproved or outdated documents in circulation?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

Seminar Summary:

This webinar will review the QSR and ISO requirements for document control, and provide a streamlined process for document control. (see full course description)

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