Mr. Doshi has held several senior-level management positions in major pharmaceutical companies, directing development and implementation of cGMP compliance strategies and initiatives in support of marketed NDA products. He has performed NDA/ANDA gap assessments, developed product specifications, and written SOPs. Mr. Doshi has subject-matter expertise in APRs, site transfer strategies, process validation programs, personnel training, product assessments, FDA review and inspection liaisons, vendor audits, quality and technical agreements for contract manufacturing, product complaint investigations, and product recall management reviews. Additionally, he has managed audits covering drug manufacturing and testing sites throughout the USA, Europe, and Asia. Mr. Doshi received his M.S. degree in Microbiology & Genetics from Illinois Institute of Technology located in Chicago, Illinois, USA, and another M.S. degree in Industrial Microbiology from Gujarat University in India. Mr. Doshi is affiliated with PDA, ISPE, ASQ, and NRM.

She has managed the planning, scheduling and resource allocation for development and implementation of a test method validation database. Mrs. Doshi has reviewed and approved batch records for product release from global countries (including from India, China, and Europe) that were destined for US market and US drug product distribution. She has performed numerous compliance audits worldwide in support of global manufacturing of clinical lots, exhibit batches, and validation lots. Mrs. Doshi has coordinated personnel training programs for GMP documentation and change control. She has performed test method and process validation execution in support of IND, PLA and PMA submissions for medical device and diagnostic manufacturing. Mrs. Doshi received her B.S. degrees in Medical Technology and Microbiology from Rush University in Chicago, and is affiliated with PDA, ASQ, and ASCP.

Mr. Weltler has assumed leadership responsibilities in coordination and implementation of projects in support of senior management needs of major pharmaceutical companies, including 12 years as Plant Director of Operations. Mr. Weltler has developed and implemented QSAP programs, GMP policies, and coordinated site FDA, EMEA, cGMP, and PAI inspections. He has held senior-level executive positions in managing programs for large scale, multi-million-dollar capital projects, including pharmaceutical facility expansions, process overhauls, major equipment installations, and systems and infrastructure upgrades within pharmaceutical and medical device environments. He has conducted dozens of GMP compliance inspections globally, has represented clients as FDA liaison both on-site and at FDA district offices, and has led the creation and implementation of compliance improvement processes in multiple pharmaceutical companies.

Mr. Weltler has a B.S. in Operations Management from Western Illinois University and is affiliated with PDA and ISPE.

Dr. Hoch has expertise in developing specifications, establishing process and cleaning validation, conducting test method validation and laboratory OOS investigations, and managing annual product reviews, product release, and recalls. He has managed R&D and QC laboratories for raw material, in-process, finished product, and stability testing. Dr. Hoch has performed cGMP and QSR compliance assessments for NDA, ANDA, PLA, and BLA submissions as well as 510K and regulatory compliance for medical device and diagnostics operations. He has served as the lead auditor for GMP audits of third party contract manufacturers. Dr. Hoch has performed site readiness inspections in preparation for FDA general inspection and PAI audits, as well as served as the on-site liaison to FDA investigators. He has experience in APIs and manufacturing of pharmaceutical liquid, solid, and parenteral drugs. Dr. Hoch received his Ph.D. in Analytical Chemistry from Purdue University and is affiliated with PDA, RAPS and ISPE.

Mr. Patel has expertise in the areas of systems design, HVAC systems, BMS systems, purified water systems, cGMP compliance, parenteral and solid dosage manufacturing, and technical writing and has experience as an Interim Facilities Manager for a biologics manufacturing site. Mr. Patel has successfully prepared, managed and submitted multiple electronic regulatory submissions according to the eCTD lifecycle guidelines through the FDA Electronic Submission Gateway (ESG). Mr. Patel received his B.S degree in Chemical Engineering from New Jersey Institute of Technology and Hands-on Aseptic Processing training from PDA. He is affiliated with PDA, ISPE, and AIChE.

He has acted as technical and/or strategy lead for European and Latin American dossier modernization efforts in support of the product lifecycle. He has experience in APIs, solid dosage forms, parenteral, and biologics. He has managed Analytical Laboratories that develop, optimize and validate analytical methods in support of excipient production and release in the chemical and pharmaceutical industry. Dr. McGregor received a B.S. degree in Chemistry from Northern Illinois University and a Ph.D. in Analytical Chemistry from Iowa State University. He is affiliated with AAPS, American Chemical Society, ALMA, and PDA.