Determine Appropriate Field Reporting Processes for Medical Device Corrections and Removals

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A review of the relevant sections of the Food, Drug and Cosmetic Act and sections of 21 CFR that FDA utilizes to regulate either the initiation and/or reporting of Medical Device Corrections and Removals, and an overview of status of SG2(PD)/N111R9 guidance document in process to address global harmonization


Speaker: Jerry Dalfors
Webinar Code: GCT 300 112
Webinar Date: 4th March 2014 10:00 AM PDT | 01:00 PM EDT
Webinar Duration: 60(Minutes)

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Webinar Description :

A review of the relevant sections of the Food, Drug and Cosmetic Act and sections of 21 CFR that FDA utilizes to regulate either the initiation and/or reporting of Medical Device Corrections and Removals, and an overview of status of SG2(PD)/N111R9 guidance document in process to address global harmonization
Objectives of the Presentation:
Participants should be able to recognize what Medical Device issues require either mandatory or voluntary field correction or removal and what the specific reporting requirements are based on safety risk associated with the issue being addressed

Areas Covered:

  • Food, Drug and Cosmetic Act (The Act) Sections 518(e) and 519(g)
  • 21 CFR 810 – Medical Device Recall Authority
  • 21 CFR 7 – Enforcement Policy
  • 21 CFR 806
  • SG2(PD)/N111R9  guidance document

Why you should attend:

To review and understand the relevant sections of the Food, Drug and Cosmetic Act and Sections of 21 CFR that FDA utilizes to regulate either the initiation and/or reporting of Medical Device Corrections and Removals, and to become familiar with SG2(PD)/N111R9  guidance document (currently in process) to address global harmonization

Who will benefit:

Quality and Regulatory Professionals in Medical Device companies who are involved in Complaint Handling and MDR Reporting and their Supervisors

Instructor Profile
Mr. Dalfors has had extensive (40+ years) consultative, technical and managerial experience in the development and manufacture of highly regulated biopharmaceutical products including injectables, biologics, medical devices and oral dosages. Prior to his current position as Principal, JD Technologies, he held management positions with major pharmaceutical and biotechnology companies as Div. Dir., Pharmaceutical Operations; Dir., Technical Services; Validation Manager; Marketing Manager; Project and Process Engineer, and Quality Assurance Testing Manager. Since then he has assisted more than a two dozen clients with the establishment of controlled document/quality systems, FDA briefing and submittal documents, managed several multimillion dollar validation projects, led facility and process design teams to assure fast track license by maintaining strict regulatory compliance during all phases of engineering, construction, commissioning and validation, and has written numerous submission documents for product, process and facility approval/licensing which have been received and accepted by the FDA and other regulatory agencies. Is considered and expert in most all aspects of the biopharmaceutical industry. He has a BS in Microbiology from Weber State University and extensive course work in business (MBA), engineering (process) and statistics.
Live Session for one participant
Price: $225.00
 
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Corporate Live Session 4 to 10 participants in single location.
Price:$885.00
 
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Recorded Session Access recorded sessions only for one participant unlimited viewing for 6 months.
Price: $275.00



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