Webinar on Current Good Manufacturing Practices (cGMP) for Medical Devices and IVDs

Compliance Trainings, Online
2014-09-06

This webinar is intended to help you get familiar with FDA’s Quality System Regulations (cGMP) for medical devices including in vitro diagnostic medical devices. This webinar is further intended to provide guidance on the best practices for implementing 21 CFR Part 820 (QSRs), which helps assure that medical devices are safe and effective for their intended use. 

This 60-min webinar will help you ensure if you engage in the best practices for establishing and maintaining quality management systems necessary to achieve compliance and to remain compliant with 21 CFR Part 820 (cGMPs).

Areas Covered in the Session :

Applicable Laws

FDA Quality System Regulations

Definitions

Design Control: Design And Development Planning, Design Input, Design Output, Design Review, Design Verification, Design Validation, Design Transfer, And Design Changes

Design History File (DHF)

Quality System Procedures, Purchasing Controls And Servicing

Inspection, Measuring And Test Equipment

Process Validation

Corrective And Preventive Action (CAPA) And Complaint Files

Quality Requirements For Premarket Approval (PMA) Application

Device History Record (DHR) And Device Master Record (DMR)

Mistakes While Implementing QSRs

How to Avoid Mistakes

Frequent Citations in 483s and How to Avoid

Top 20 Items Cited in 483s

Lessons Learned:  Best Practices

Who Will Benefit:

CEOs

VPs

Compliance Officers

Attorneys

R&D and Manufacturing Managers

Managers (RA, QA/QC, CA)

Consultants

Contractors and Subcontractors

Price tags:

Live

Single Live : For One Participant

$ 249

Corporate Live : For Max. 10 Participants

$ 899

Recording

Single REC : For One Participant - Unlimited Access for 6 Months

$ 299

For more information and enquiries contact us at

Compliance Trainings

5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada
Customer Support : #416-915-4458 
Email : support@compliancetrainings.com

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.com). Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009. Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author. Dr. Lim leads and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor.

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