On-site Training

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…

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

pdf-brochure

Anagha Maharao