The Training Policy of AQC is “to make an individual independent and confident enough to be able to contribute to their organizational goals efficiently”.
In order to achieve this AQC has carefully chosen its trainers from various expertise like GMP, QMS, QA, QC, Production, Regulatory Affairs, Research and Development and Human Resources.
METHODOLOGY
- Interactive Lecture
- Power Point Presentation
- Questionnaire
- Case Study
- Compliances Issue Guidance
- Functional Activities etc.
SOME OF OUR SPECIALIZED TRAINING MODULES ARE AS BELOW:
GMP Training:
- Good Manufacturing Practice (GMP)
- Good Documentation Practice (GDP)
- Good Laboratory Practice (GLP)
- Good Warehousing Practice (GWP)
- Good Engineering Practice (GEP)
- Concept of QA & QC
- Calibration, Qualification & Validation
- Clean Room Cleaning & Sanitization
- Self-Inspection & Quality Audits
- Vendor Qualification
- Waste Control & Disposal
- Environmental Monitoring
- Identification and Traceability
- Handling Non-conformances
- Handling Deviations
- Change Control
- Corrective Acton and Preventive Action
- Handling, Storage, Packaging, Protection, Safety & Delivery of Material
Quality Tools Training:
Cost Saving projects •
Lean Implementation •
5’s Implementation •
Kaizen Implementation •
Standards Training:
- ISO 9001:2015
- ISO 13485:2016
- ICMED 9000 & ICMED 13485
- MDR 2017 Schedule –Vth
- Directive(93/42/EEC)
- In-vitro diagnostic medical devices (Directive 98/79/EC)
- ISO 14001 :2004
- OHSAS 18001:2007
- Clinical Evaluation Meddev 2.7.1 Rev. 4
- Risk Analysis EN ISO 14971:2012
- Regulatory Orientation (Medical Devices)
- MDR 2017-745. Medical Devices