FDA Training: Controlling US Regulation of Medical Devices

The US Food and Drug Administration (FDA) recommends using the 21 CFR 211 and 21 CFR 820 regulations to ensure compliance with US regulations. The AMM file (CTD) complements the quality assurance aspects with ICH reference documents, European and American guidelines.

educational goals

• Understand and control the requirements of US regulations (21 CFR)
• Assimilate the production process of a medicine
• Integrate the implications reported to FDA regulations
• To understand the notion of continuous improvement 

 The implications of FDA regulations on form and substance

• Definition of the 21 CFR 820
• Articulation with the NF ISO 13485 standard
• The field of application
• The principle of continuous improvement and QMS
• Back to terms and definitions

Process management

• What is a process?
• The different types of processes
• Description of a process
• Piloting and control of the process
• The benefits of the process approach

Fields of application, generalities and scope of application

• General requirements
• The documentation for 21 CFR 820
• Mastery of recordings (820.180, 181, 184, 40)
• The commitment of management (820.20)
• Management responsibility: quality policy, planning, authority, management review

Resource management

• The provision of human resources
• Infrastructure management
• The work environment
• Product realization (QMS planning, measurement, analysis, improvement)
• Product realization planning

Conception and development

• Design products that meet specifications
• Validation and evaluation of processes
• Ensure the conformity of the purchased products with the requirements
• Product realization activities
  • Mastery of activities
  • Mastery of production and service preparation
  • Validation of the realization processes
  • Identification and traceability
  • Product preservation
• Labeling and packaging

Control of measurement and monitoring devices

• Controlled measuring and monitoring devices / reliable results
• Measure, analyze data and improve
• Internal audit
• Evaluate the effectiveness of the QMS: process suitability and product compliance
• Non conforming products
• Corrective or preventive actions
• Claims and after-sales service

• Target audience

• Laboratory staff
• Pharmaceutical laboratories

Prerequisites

It is recommended to have knowledge of GMP, CE marking to follow the FDA training

• Teaching Methods for FDA Internship - US Regulation of Medical Devices (21 CFR 820)

• Theoretical and practical contributions
• Case studies
• Group exchanges
• FDA training course support

Dates and places

Start date	End date	Training site
06-02-2018	07-02-2018	Paris 15
21-05-2018	24-05-2018	Paris 15
18-07-2018	19-07-2018	Paris 15
18-10-2018	20-10-2018	Paris 15

 For Further info visit https://www.cnfce.com