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Webinar On Managing Product Recalls in Accordance with Part 806

 
  October 27, 2014  
     
 


Compliance Trainings, Canada
2014-12-04


It is inevitable that eventually a device manufacturer will need to execute a correction or market-withdraw for a medical device. The actual process of managing a market-withdraw is time consuming; and if poorly executed can result in a visit from the FDA, while alienating the customer base. It is not unusual for FDA to spend a fair amount of time reviewing the recall files during an inspection, especially if the device establishment has executed a Class I or Class II recall since their previous establishment inspection.

Device establishments that have a well-defined process for managing product recalls typically avoid many of the pitfalls associated with managing recalls in the fire-fighting mode. Granted, product recalls are challenging events, device establishments can benefit when recalls are efficiently and effectively executed. This Webinar breaks down the elements associated with the product recall process and provides attendees with a fundamental understanding of the FDA’s recall requirements delineated within Part 806, while providing the tools needed for compliance.

Areas Covered in the Session :

21 CFR, Part 806 compliance requirements

Understanding the different types of field actions:

Market withdraw

Stock recovery

Correction

Classification of Recalls

Creating an effective Recall Packet

The recall notification process

Reporting recall-related activities to the FDA (required reports)

Recovery and quarantine of product

Disposition of recalled product (certified destruction or rework)

Formal closeout of a recall, including the FDA notification process

Who Will Benefit:

Beneficiaries of this Webinar will be

Quality Professionals

Regulatory Professionals

Customer Service Professionals

And everyone involved in the recall process, including the customer notification process, FDA notification process; creation and issuance of recall packets; product recovery process; product quarantine process; management of 3rd-Party Recall Service Providers; and the destruction of recalled product.

Price List:

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=MD1441

 
 
Organized by: Compliance Trainings
Invited Speakers:

Speaker Profile

Dr. Christopher Joseph Devine is the president and founder of Devine Guidance International, Inc., (DGII) a consulting firm providing regulatory and quality compliance support for the medical device industry. Prior to launching DGII, Dr. D spent 14-years with Boston Scientific Corporation working in a variety of quality and regulatory management roles. Additionally, Dr. Devine is the author of Devine Guidance, a weekly blog focusing on quality and regulatory compliance issues facing the medical device industry; and published by the Medical Device Summit, an e-magazine.

Furthermore, Dr. Devine has 35-years of combined experience in the fields of quality assurance and regulatory affairs; and is a senior member of the American Society of Quality (ASQ), a member of Regulatory Affairs Professionals Society (RAPS), a member of the Society of Manufacturing Engineers (SME), and a member of the Project Management Institute (PMI).

Dr. Devine received his doctorate from Northcentral University, with his doctoral dissertation entitled, “Exploring the Effectiveness of Defensive-Receiving Inspection for Medical Device Manufacturers: A Mixed-Method Study. Finally, Dr. Devine is the author of five books on quality and regulatory compliance.

 
Deadline for Abstracts: 2014-12-04
 
Registration:

https://compliancetrainings.com/siteengine/Login.aspx

E-mail: suzzane.d@compliancetrainings.com; uttam@compliancetrainings.com
 
   
 
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