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In the third stage of the ongoing in-house training programs by the CII Institute of Quality in the area of phrama and biotech, two programmes were conducted in the month of July 2008 with Dr. Shib Mookherjea, a global expert, as the faculty.
The first program was conducted in Aurobindo Pharma, Hyderabad on 7th and 8th of July 2008. The program was on "Workshop on Deviation Reporting and CAPA".
The course was designed to address a system to analyze and control manufacturing through timely measurement of critical quality and performance attributes of raw and in-process materials through corrective and preventive action program (CAPA). The course covered the regulatory validation and deviation reporting norms in-compliance with U.S. and International regulations and guidelines pertaining to the pharmaceutical industry. This program was selected by the organization due to the fact that CAPA system is the central core factor in the integrated quality system mostly followed by any chemical industry.
The program contained essential theme of system designing analysis and control of manufacture through timely measurement of critical quality and performance functions of raw and process material through corrective and preventive action program (CAPA).
The program was attended by 40 officials of the organization starting from VP, GM, Quality and production, regulatory and other functional heads along with their senior staff. Dr. Mookherjea of VQI International, while conducting the programme, took up specific company case studies pertaining to deviation reporting and CAPA which were discussed and analysed with logical conclusions. The company, at the end of the programme, felt that these will eventually be useful for the organization in their day to day functioning and operation.
The second program was organized on the topic "Highlights of Good Laboratory Practice Standards (GLP)". This was conducted in Jubilant Organosys on 14th and 15th of July, 2008 at Roorkee.
The program provided participants with an understanding of terminology with acceptable practices under good laboratory practices (GLP) for testing and compliance. The course covered the regulation, methodology and current issues involving international harmonization and understanding of the needs through documentation. Functions related to quality assurance responsibilities and need to effectively conduct GLP compliance was also discussed.
The program intrinsically contained the current issues related to good laboratory practices (GLP) functions related to QC and QA, need for effective audit, documentation and responsibility.
The program was well attended by 25 top executives drawn out from different functional groups of the organization including QC/QA, regulatory, R&D, production and other functional areas. The various company specific case studies were undertaken, deliberated and logical conclusions were drawn under the guidance of Dr. Shib Mookherjea of VQI International USA. These would immensely help the organization in implementing their day to day operation and function.
Dr. Shib Mookherjea conducting a training session
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