Webinar On Pharma Graphics

Compliance Trainings, Online
2014-11-20

Lack of an effective complaint management system is one of the more frequent Form 483 observations cited during FDA device establishment inspections. In fact, failure to process complaints in a timely and uniform manner will quickly lead to other Quality Management System issues such as late Medical Device Reports (MDRs) or the potential to completely miss an opportunity to file an MDR for a serious adverse event.

If your organization is struggling with an overly burdensome complaint management system or the number of complaints is continuing to rise with no end in sight, then now would be a good opportunity to streamline your organization’s approach to complaint management.

This Webinar will breakdown the complaint management process so attendees will be exposed to a clear, concise and compliant approach to complaint management in accordance with 21 CFR, Part 820.198 requirements. Remember, there are no such things as maximum compliance or minimum compliance; there is just compliance when it comes to meeting the FDA’s requirements for the complaint management system.

Areas Covered in the Session :

Reviewing the Requirements Associated with 21 CFR, Part 820.198

Understanding the agency’s interpretation of processing complaints in a timely and uniform manner.

Information that needs to be incorporated into a complaint file.

The complaint investigative process.

Processing oral complaints.

Use of decision trees to determine the need to report a complaint as an MDR reportable event.

The documentation process for when a decision is made not to investigate a complaint.

Customer response letters and follow-up.

Linkage to the CAPA System

Who Will Benefit:

Quality Professionals

Regulatory Professionals

Customer Service Professionals

Medical Science Professionals

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

For more information about this event please visit

https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1440

Ronald D. Snee, PhD, is Founder and President of Snee Associates, a firm dedicated to the successful implementation of process and organizational improvement initiatives. He provides guidance to senior executives in their pursuit of improved business performance using Quality by Design, Lean Six Sigma and other improvement approaches that produce bottom line results. Prior to his consulting career he spent 24 years at the DuPont Company in a variety of assignments including pharmaceuticals. He has been developing and applying QbD methodologies for more than 30 years. His recent application and research on QbD has produced more than ten articles on use of QbD in Pharma and Biotech. He has also coauthored 2 books on the methods and tools of QbD and speaks regularly at conferences and meetings on the subject. He teaches QbD and related methodologies as an Adjunct Professor at Temple University School of Pharmacy and Rutgers University Pharmaceutical Engineering program.

Ron received his BA from Washington and Jefferson College and MS and PhD degrees from Rutgers University. He is an academician in the International Academy for Quality and Fellow of the American Society of Quality, American Statistical Association, and American Association for the Advancement of Science. He has been awarded ASQ’s Shewhart and Grant Medals, and ASA’s Deming Lecture and W.J.Dixon Consulting Awards as well as numerous other awards and honors. He is a frequent speaker and has published 5 books and more than 255 papers in the fields of performance improvement, quality, management, and statistics. He is a past recipient of the Institute of Validation Technology Speaker of the Year Award.

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