Pharmaceutical Regulatory Inspections (3rd Edition)

Madhu Raju Saghee
Dr Madhu Saghee is Head of QA at Encube Ethicals. His areas of expertise include all aspects of quality and compliance for systems, processes, facilities and operations for drug products, particularly for sterile products. Madhu is
a founding member of the Indian Special Interest Group (ISIG) of the Pharmaceutical & Healthcare Sciences Society, UK. He was bestowed with the “Young Pharmaceutical Analyst Award” by the Indian Drug Manufacturers’Association in 2013.Madhu has written many articles pertaining to regulatory compliance, quality assurance, quality risk management, cleanroom contamination control and microbiology. He is the editor co-editor of the following books: Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices, Cleanroom Management in Pharmaceuticals and Healthcare and Achieving Quality and Compliance Excellence in Pharmaceuticals. He has been a speaker at various international conferences on sterile manufacturing and regulatory compliance. Madhu has a Master’s Degree in Microbiology and a PhD in  Bioremediation and Meta-genomic Analysis. He is an active member of Various industry associations, including PDA, PHSS and ISPE.

Tim Sandle
Professor Tim Sandle is the Head of QA Compliance at the UK Bio Products Laboratory (Kedrion Biopharma UK). He is also visiting tutor with the School of  Pharmacy and Pharmaceutical Sciences, University of Manchester and professor of microbiology at University College London (UCL). Tim is a chartered biologist (Royal Society of Biology) and a Fellow of the Institute of Science Technology. He holds a First Class Honours Degree in Applied Biology; a Masters degree in Education; and a PhD in blood products.Tim serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control, including the pharmaceutical microbiology society, Pharmig. Tim has written over 1000 peer-reviewed papers and technical articles, including chapters and books relating to microbiology and quality assurance. In addition, Tim is editor of GMP Review
and he runs a microbiology related website: www.pharmamicroresources.com.

Gary Bird
Dr Gary Bird is Senior Vice President for Quality Oversight at Veru, Inc.; a US corporation focused on prostrate health drug products. He has over 35 years' experience in the pharmaceutical and biotechnology industries. His broad areas of expertise include regulatory affairs, quality system analysis, FDA compliance, team leadership, continuous improvement, and vendor relations.Throughout his executive career, Gary has held leadership positions at pharmaceutical and biotech-related organizations including the Food and Drug Administration (CDER and CBER), Eli Lilly and Company, GTx Incorporated, Geno Rx, and his consulting firms PharmaConsult US and PharmaConsult Global Ltd. He represented both FDA and Industry in the International Conference on Harmonization (ICH) negotiations. He was responsible for developing and overseeing a Corporate Quality System for all GXP compliance activities while ensuring continuous improvement in system reliability by creating and implementing a Corporate Quality Plan; overseeing all non-clinical (GLP), manufacturing (GMP), and clinical trial (GCP) activities and ensuring their compliance with relevant laws and regulations, including creating a GCP audit program to monitor clinical trials conducted inside and outside of the US.Gary holds a BS in Invertebrate Zoology and Chemistry and an MS in Invertebrate Zoology and Biochemistry from Memphis State University as well as a PhD in Entomology and Enzyme Biochemistry from Mississippi State University. He has authored and delivered numerous lectures and training courses as part of his consultancy services on subjects including best manufacturing practices for biopharmaceutical products, introduction to GMPs, introduction to biosafety, and stability of biopharmaceutical products.