Interpretation and Implementation of RDC 16

Interpretation and Implementation of RDC 16

The RDC 16: 2013 Qualification in Interpretation and Implementation aims to enable professionals to understand and apply the requirements established by ANVISA for Good Manufacturing Practices and Control of Medical Products, within the scope of activities of the organization - Manufacturing, Importing and / or Distribution of Medical Products.

Methodology

Exposition and discussion of content, accompanied by exercises for assimilation of concepts and contextualization of regulatory requirements in the organization, through the development and analysis of Case Studies.

Content

Regulatory Context
  • Structure of the National Health Surveillance System: competencies of ANVISA and State and Municipal Surveillance
  • Requirements for Business Operation and Product Registration
  • Applicable Legal and Regulatory Framework Review - Relationship with ISO 13485
Requirements RDC 16/2013 ANVISA - Good Manufacturing Practice - Medical Products
  • General Provisions
  • General Quality System Requirements
  • Quality Documents and Records
  • Project Control and Master Product Registration
  • Process and Production Controls
  • Handling, Storage, Distribution and Traceability
  • Corrective and Preventive Actions
  • Installation and Technical Assistance
  • Statistics Techniques
ANVISA Best Practice Certification Process
  • Types of Certifications and Implications
  • ANVISA Certification Schedules and Deadlines

Interested in our Services? Contact us!

Regulatory Framework