To get a detailed insight on FDA's requirements for cleaning validation, Easy Solutions, a consultancy based product supplier to the Indian life sciences industry is planning to host a seminar on 'Cleaning Validation'in Mumbai soon. The seminar would be conducted at ITC Sheraton Grand Maratha from 6- 8th February 2006. The seminar will be conducted by Destin LeBlanc, an expert in technical consulting services for all aspects of cleaning, cleaning validation, and related technologies for process equipment in pharmaceutical manufacturing and other related industries.
"We will be having key personnel from Glenmark, Lupin, IPCA, Serum Institute, Nicholas Piramal, Johnson & Johnson, Orchid, etc attending this seminar as this issue has become very critical especially for those units that have US FDA or MHRA approval. Atleast 40% of the 483's issued to API units in 2004 by the US FDA was cleaning validation related," said the company sources.
Cleaning technologies, Cleaning validation concepts and practice, Regulatory aspects of cleaning validation, Cleaning methods, Analytical and sampling methods, Monitoring of cleaning, Derouging of process equipment, Passivation of process equipment, Microbial control in cleaning validation for FDA etc. will be discussed in the seminar.
LeBlanc regularly trains FDA investigators on cleaning validation issues. He has spent more than 25 years in the field of pharmaceutical cleaning validation, and has written and lectured internationally on cleaning validation, both as part of technical symposia as well as on-site company training. He holds nine patents and has authored numerous articles including a book on cleaning validation.
Easy Solutions is planning to host many such seminars in the country under the category 'Critical Issues in the Life Sciences industry.' "Our aim through such seminars is to introduce our clients to the current trends in US and Europe," said the sources.