This training is conducted at company office or manufacturing site for its 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

Regulatory Affairs :

• DMF & Dossier Preparation
• ANDA, MAP, CEP, ASMF, USDMF
• ICH Quality guidelines
• Handling Deficiencies
• Selection of Starting Materials
• Review of DMF and Dossiers