Effective Records Management & Document Control for Medical Devices

Website http://www.traininng.com/webinar/effective-records-management-&-document-control-for-medical-devices | Edit Freely

Category Educational trainings, HR professionals, Human Resource, Online trainings, Employee Relations

Deadline: November 04, 2019 | Date: November 05, 2019

Venue/Country: Online, U.S.A

Updated: 2019-09-20 14:24:01 (GMT+9)

Call For Papers - CFP

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Do you have unapproved or outdated documents in circulation?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

Consultants

Quality System Auditors

Speaker 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.