COURSE OUTLINE
This 1 day special Quality System Regulation training program is intended as an introductory course to enable participants to have a basic understanding of US FDA Quality System Regulation, Quality System Inspection Techniques (QSIT) approach. Moreover, participants will be provided with tips for handling inspector during FDA inspection as well.
Who Should Attend
Managers, Executives, Supervisors of various departments: Quality Assurance, Production, Regulatory Affairs, Laboratory, Logistics, Purchasing, Management Representatives, Inspectors and Internal Auditors should attend this seminar.
Seminar Materials
Seminar manual with case studies.
Seminar Goals
- Understanding and implementing Quality Management System according to Quality System Regulation
- Applying QSIT approach and decision-making skills in a wide variety of audit situations
- Understanding tips for handling auditor / inspector
Seminar Outline
- FDA Quality System Regulation Requirements
- Subpart A – General Provisions
- Subpart B – Quality System Requirements
- Subpart C – Design Controls
- Subpart D – Document Controls
- Subpart E – Purchasing Controls
- Subpart F – Identification and Traceability
- Subpart G – Production and Process Controls
- Subpart H – Acceptance Activities
- Subpart I – Nonconforming Product
- Subpart J – Corrective and Preventive Action
- Subpart K – Labeling and Packaging Controls
- Subpart L – Handling, Storage, Distribution and Installation
- Subpart M – Records
- Subpart N – Servicing
- Subpart O – Statistical Techniques
- Quality System Inspection Techniques (QSIT)
- Management Controls
- Design Controls
- Corrective and Preventive Actions
- Production and Process Controls
- Equipment and Facility Controls
- Material Controls
- Records, Documents and Change Controls
- Preparation for US FDA Inspections