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Our Technical Mentor: C K Moorthy

C K Moorthy conducting GMP Training at different venues

 

C K Moorthy is a graduate in Electrical & Electronics Engineering from the Indian Institute of Technology, Mumbai, with microelectronics and biomedical as his electives. He went on to complete postgraduate qualification in marketing management from the Institute of Marketing, London.

Moorthy's professional career began in the early ‘70s as an applications engineer with the Authorised Exclusive Distributor in India of a host of medical equipment manufacturers based in USA, each the market leader in the given segment. His responsibility was to train field sales staff as well as end users in proper selection, use and care of equipment that were intended for different departments: coronary, respiratory, gynaecology, nephrology, oncology, pathology and, of course, the operating suites, recovery and intensive care wards. Here he was fortunate to find a mentor who nurtured his technical, analytical and communication skills, and moulded him for a career in training.

Moorthy then joined a group of engineers in Mumbai specializing in airborne contamination control and cleanrooms for semiconductor and defence applications. He was able to extend their footprint into satellite payload and satellite integration, precision assembly areas and finally back to where he first began: hospitals! He assisted in airborne infection control with designs for “bioexclusion” environs for general operation theatres; and “bioexclusion” with “biocontainment” for their pathology, “septic” theatres, “burns” wards and patients with immunosuppressive treatment.

With increasing investments in cleanrooms in Pharmaceutical manufacturing in the late ‘80s and early ‘90s, Moorthy was invited by a pioneer in the field to help set up a "GMP" Academy. His role was to organize and conduct training workshops, as well as oversee a core group that researched and compiled technical monographs on topics of relevance to Pharmaceutical Manufacturing.

Moorthy's passion lay more in "training" than in “promotion”, and in 1996 he decided to go solo with this concept, so that he could peel off the “promotional spin” that was intrinsic and integral to his earlier "sponsored" platform. He wished to be perceived as a speaker and teacher whose credibility lay in the fact that he had no vested interests, and no hidden agenda in his suggestions or recommendations.

Moorthy's lectures have drawn participants from a whole host of diverse industries. He is regularly invited as Faculty for in-house training programmes by various Organisations, both Private and Governmental; and as a speaker at National and International Seminars and Conferences.

His intimate knowledge of his subject, and his ability to present complex concepts and insights, to both laymen as well as professionals and management, in a manner that is practical, easy to understand and implement has won him acclaim all round, as amply vindicated by the feedback received from participants.

Moorthy's uncanny ability to anticipate emerging regulatory expectations is best exemplified by the following (of several) examples: his passionate appeals to the audience to convert captured data to information and knowledge, and apply such newly acquired knowledge to improve processes and grow in experience and understanding (current Regulatory description of "Desired State"); his consistent emphasis on the importance of Process Capability Analysis way back in 2001, much before ICH Q8 (QbD); his recommendation that there should be a "bridge" group to interact with R & D on the one hand, and Production on the other for smooth scale-up, which is now reflected in ICH Q10 and the lifecycle approach to Process Validation; his strong advocacy for appointment of Subject Matter Experts to take responsibility and oversee Project Planning and Execution since 2003, which is now specified by ASTM E 2500 (2013), and the USFDA Process Validation Guidance Document of January 2011; and, finally, his contention that Failure Investigation and Quality Risk Management (ICH Q9) are, indeed, two sides of the same coin: the former being a reactive, and the latter a proactive, response that ultimately leads to Corrective and Preventative Action (CAPA), has been abundantly vindicated in ICH Q10 which holds the same view and strongly advocates use of CAPA more proactively.

His first book Contamination Control & Cleanrooms: Principles & Practices was published in 2003. His second book Current Good Manufacturing Practices: Volume I - Resource-related Aspects and his third book: Current Good Manufacturing Practices: Volume II - Manufacturing and Controls related Aspects (including Pharmaceutical Validation) were released in 2004 and 2005 respectively. Many of these books have since become standard reference texts in the Industry. His current crop of books are sold exclusively through Amazon.in.

Chandersekhar K Moorthy
Chartered Engineer
B Tech (Hons), MIE, MIEEE (USA)
A Inst M (UK), MBIM (UK)


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