Speakers

Tim Sandle

Pharmaceutical Microbiologist & Head of Compliance & Quality Risk Management
Bio Products Laboratory & Pharmig Committee Member

Tim is the Head of Microbiology at the UK Bio Products Laboratory. His role involves overseeing a range of microbiological tests, batch review, microbiological investigation and policy development. In addition, Tim is an honorary consultant with the School of Pharmacy and Pharmaceutical Sciences, University of Manchester and is a tutor for the university’s pharmaceutical microbiology MSc course. Tim is a chartered biologist and holds a first class honours degree in Applied Biology; a Master degree in education; and a PhD in microbiology. Tim serves on several national and international committees relating to pharmaceutical microbiology and cleanroom control (including the ISO cleanroom standards), and he has acted as spokesperson for several microbiological societies. He is a committee member of the microbiology society Pharmig. Tim has written over one hundred-and-fifty book chapters, peer reviewed papers and technical articles relating to microbiology. Dr. Tim Sandle, Head of Microbiology, BPL

[ KEYNOTE SPEAKER ]

Manish Bhatkar

Founder & CEO,
Redlotus Pharmtech Private Ltd & Overseas Pharmig Committee Member

Is an experienced pharma professional, diligent in his core functional area (pharmaceutical technical operations) and committed to the profession. Before founding RedLotus Pharmtech Private Limited (A Technical Services Company) in 2016, in his 25 years of service, he has discharged executive as well as leadership responsibilities in the areas of design & development, manufacturing, qualification & validation, operations management, quality assurance, quality management, audits & compliance, regulatory affairs, technology transfer, project management, and technical consulting. He has worked in R&D, API’s, formulations and technical consulting environments and has demonstrated equivalent capabilities in managing manufacturing, technical as well as quality operations with ease. He was instrumental in establishing and growing the validations & GMP compliance services business vertical for a German pharmaceutical engineering house Pharmaplan GmbH (Now, NNE Pharmaplan) in India. As head of the Dabur Oncology Plc. Operations, in his 5 years’ tenure in UK, he single handedly lead the efforts in resolving complex technological, regulatory and GMP compliance issues (including USFDA warning letter) that resulted in making commercial manufacturing and product supplies possible from the site.

[ EXPERT SPEAKERS ]

David Keen

Director,
Pharmaceutical Microbiology - Ecolab & Pharmig Chairperson

David is a pharmaceutical microbiologist who has worked across the pharmaceutical industry including in primary and secondary manufacturing, both sterile and non-sterile dose forms, for FMCG, CMO and clinical trial manufacturing. David has also presented and chaired at numerous meetings, conferences and training courses with his own unique flair and personality and is currently updating Pharmig’s Guide to Microbiology in Pharmaceutical Laboratories. David is experienced in sterility assurance for dose forms ranging from bulk API to small molecule sterile injectables. He is experienced in both terminally sterilized and aseptic processes, non- sterile liquids, topical products, inhalations and more specialist dose forms such as radiopharma, vaccines and highly potents. David’s experience includes dealing with regulatory inspections (MHRA, FDA, EMA, TGA etc), internal and external auditing. He works with teams to solve complex microbiological issues such as non-sterile contamination events, sterility test failures, media trial failures, SIP and moist heat failures

[ EXPERT SPEAKERS ]