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Competence and Training Requirements for Auditing Organizations
Origin/Publisher:
IMDRF
Content:
This document applies to recognized Auditing Organizations conducting audits of a medical device manufacturer for regulatory purposes. Adherence to this document and its requirements will help mitigate the risk of inconsistent or ineffective assessments of manufacturers by ensuring that Auditing Organization personnel have the necessary commitment, competence, experience, and training before conducting an audit or undertaking a decision making function.
GMP Conferences by Topics
- General Quality Assurance and GMP Compliance Topics
- Hygiene
- General Microbiology Topics
- Regulatory Affairs
- Development
- General Analytics Topics
- Good Distribution Practice
- Sterile Manufacturing
- Computer Validation
- General Qualification/Validation Topics
- General Engineering Topics
- APIs/Excipients
- GMP Basic Training Courses
- Medical Devices and Combination Products
- Packaging and Packaging Material
- Data Integrity
- Qualified Person (QP)
- GMP Auditing
- Documentation
- Cleaning Validation
- General IT Compliance Topics
- Impurities
- OOS / OOE / OOT
- Material Testing
- Validation of Analytical Methods
- Analytical Instrument Qualification
- Stability Testing
- Microbiological Testing
- Technology
- General Manufacturing Topics
- Solid Dosage Forms/Semi-Solid Dosage Forms
- Biotechnology/Blood/ATMP
- Herbal Drug Products/Cannabis/Radiopharmaceuticals
- Others