This training is conducted at company office or manufacturing employees in India and abroad. Company may select the topics of their interest related to Quality Control/ Quality Assurance / Regulatory Affairs/. It may vary from 1 day to 7 day.
Recently conducted on-site training at AstraZeneca, Bangalore (June 2014) & at Polypeptides, FDC, IDA Foundation and more…
On-site Training
Salient features :
- Tailor-made programme
- Course contents based on current approach of regulatory agencies
- Experienced industrial faculties
- Discussion with case studies
- Evaluation and certification
On-site training topics :
Quality Control :
- OOS & OOT management
- Laboratory Incidences management
- Data Integrity Management
- Reporting and review of Analytical data
- Stability management
- Analytical Method Validation
- Competency enhancement of Analysts & supervisors
- Management of Laboratory Standards, Glassware & Reagents
- Qualification & Calibration of Instruments
- Inspection- observations & recommendations
- Sampling & samples management
- Handling of Pharmacopoeial changes
- Laboratory or Analytical QA
Quality Assurance :
- Change Control & Deviation Management
- Vendor Qualification
- Review of Batch Records
- Training
- Technology Transfer
- Designing Specifications
- Product Complaints and Recalls
- Good Documentation Practices
Regulatory Affairs :
- DMF & Dossier Preparation
- ANDA, MAP, CEP, ASMF, USDMF
- ICH Quality guidelines
- Handling Deficiencies
- Selection of Starting Materials
- Review of DMF and Dossiers
