To meet the expected high growth and consequent boom in the Indian Pharma sector, India needs to leverage its inherent strengths to its collective advantage in the area of drug discovery and production through cost competitive manufacturing base, world-class skills in chemistry and process development, improved skill sets in biotechnology and development research. Hence, the training programmes are designed to meet the gap and bridge the need for specialised training as per international standards.
The three training programmes conducted were:
Mandava Associates, USA brings to the table a team of renowned specialists and practitioners with hands-on experience and exposure to FDA, MHRA, WHO, EPA, OECD and other international regulatory standards.
This is the second round of training programmes jointly conducted by CII-IQ and Mandava Associates in the last six months after receiving encouraging responses from the Indian Pharma industry from the first round.
Dr Shib Mookherjea, well known international faculty in the Pharma sector, representing Mandava Associates, USA conducted three In-house workshops of 2 days duration each.
- Pharmaceutical Development Process Optimisation QA/QC Validation - March 13 - 14, 2008 at Neuland Laboratories, Hyderabad
- Process Analytical Technology (PAT) - March 17 - 18, 2008 at Zydus Cadila, Ahmedabad
- Integration of ICH Directives for CGMP - March 19 - 20, 2008 at Jubilant Organosys, Roorkee.
The programme were highly interactive and covered the international quality system approach, genesis, process criteria, measurement resolution, errors, uncertainty, ICH Process and Integration, Role of QA/QC, Controlled Chart Implementation, Risk Assessment Approach (ICH Q9), Statistical Tools and Implementation and Validation of Analytical Procedures.
While Neuland Laboratories, Hyderabad has just applied for CII membership, the other two companies are existing CII Members. There were 30 participants in each programmes who gained immense knowledge which reflected in the highly interactive interactions and excellent feed-back.