Hi Reddit! I am Shib Mookherjea, Principal of Val Qual International, a Consulting/Training company offering various advisory and Management Training services to the Pharma, Biotech, and Medical Device industries both in the US and abroad. I have diversified expertise and experience in Analytical Development, R&D, QA/QC, and Laboratory Management, having held supervisory and leadership positions in several companies spanning over 25 years. I have proven track record of initiating and implementing GLP/GMP in several laboratories in addition to leading Analytical, R&D and QC teams and have offered targeted training courses in more than 20 countries. I have had also extensive experience in the areas of Pharmaceutical Development, Methods Transfer, Analytical Problem Solving, PAT applications, and Team Development and Regulatory submissions. I have held management and supervisory positions for Colgate-Palmolive, Johnson & Johnson, Troy Corporation, Allergan and CRO/CMO organizations. I have been on the faculty of Continuing Education Division of American Chemical Society, CFPA, Sindusfarma (Brazil) and several other international organizations. The aim of these training initiatives is to foster professional development while bridging the gap between academic training and industry-required knowledge base for Chemists and Scientists holding positions in various industries. Ask me questions on and about the topics of Analytical Methods Development, Validation of Methods, Qualification (IQ, OQ, PQ) of lab equipment and systems, FDA GLP Regulations, and QA/QC in Pharma labs. I’ll be back at noon EDT/9:00am PDT to answer your questions! EDIT: I am ready to answer your questions. As a thank you for participating in this AMA, we’d like to extend a discount to you for any of my courses offered through the American Chemical Society. Register between now and August 1, 2016 using the code ACSREDDIT20OFF to receive 20% off of your registration fee.