Mohammed Khan is a Quality Management Consultant and Principal, Synergex Consulting, Canada. He had earlier directed the Manufacturing, Distribution, QA/QC and Regulatory Compliance operations with DuPont Pharmaceuticals, Canada, and served as a Director of the Pharmaceutical Manufacturers’ Association of Canada/Plant Operations Section. He has served on the DIA Advisory Council of North America and Chaired the DIA Canadian Programming Steering Committee, and is a recipient of the DIA Outstanding Service Award. He further served as Program Coordinator, Program Committee Member, Session Chair and Speaker at various DIA events, and a Presenter for the PDA, IQPC, PSG (Canada), and IPC (India).

Quality System Management, CMC, QA Audits of API and Dosage Form Manufacturers, Technology Transfer, Change Control, GMP Training, Document Management, Contract Negotiation, CMO Management

Rama K Pidaparti is a Ph.D candidate from ASU and attended Life Sciences and HealthCare courses from BEP Program at Sloan School of Management, MIT. Has over 20 years of industry experience and is currently Principal Consultant, Medical Devices vertical, Wipro Technologies. Rama worked at many large Global Medical Devices and Biotech drug companies as a consultant; GEHC, J&J, Genzyme, Genentec, Zimmer, and Boston Scientific to name a few. He is an advisory consultant helping clients with Business Processes and Validated implementations of Computerized Systems for R&D, Quality and Regulatory areas and also an invited speaker on Quality and Regulatory Compliance topics at Life Sciences events in the past 10 years.

SDLC, PLM, SCM, QMS (Complaints, CAPAs, Supplier Controls, Document and Change Management) & Regulatory Affairs, including Information Security and Risk Management

Chitra Edwin is a consultant, and Principal, Biotechnology Consulting Solutions, Ltd. (www.biotechconsultsolns.com). She has significant product development and management experience in biotechnology, device and IVD companies. She has been a key member in the development of products for infectious diseases, and oncology that have regulatory approval. She is an Adjunct Associate Professor of Pharmaceutical Sciences, University of Cincinnati. She obtained her Ph.D. from the University of Minnesota, and post-doctoral training at the Harvard Medical School, and the Dana Farber Cancer Institute. She has RAPS certification. She is a Board member of Opus Institutional Review Board (IRB).

Biopharmaceutical, Diagnostic and Medical Device Product Development, Regulatory Affairs, Regulatory Strategy, Regulatory Compliance, Technology Assessment and Technology Transfer, FDA, ICH Regulations, Risk Management

Kurt holds a Master’s degree in Nursing and has been working in clinical research since 1992. He started his career as a study co-ordinator and has since developed his career working on a number of device and biotech studies in and outside Europe. Besides gaining a lot of scientific experiences, he gained a lot of regulatory knowledge and his knowledge involved in the development of regulatory processes and the regulatory aspects of clinical trials. He is also involved in medical writing, auditing and quality assurance.

Oncology/immunology, medical devices, EU and US regulations

Elijah Narplah Wreh received his Bachelor of Science degree in Human Biology from Minnesota State University – Mankato and his Master of Science degree in Regulatory Science from the University of St. Thomas. A high energy and extraordinary acumen regulatory affairs executive, he approaches each new regulatory challenge with his fundamental aptitude for innovation, creative problem solving driven skills, and measured risk-taking to drive consistent bottom line improvements and help medical device manufacturers and received regulatory marketing clearance. He is the President of Wreh Regulatory Consulting Firm located in Minneapolis, MN and in addition, he serves as a Regulatory Affairs Specialist at Stryker Osteosynthesis Division located in Mahwah, NJ. He began his regulatory career on a path that is rare among other Regulatory Affairs Professionals. Recognized as high potential regulatory affairs professional, in 2011 he was appointed as a Medical Device Staff Fellow through the Food and Drug Administration Center for Devices and Radiological Health Medical Device Fellowship Program. At the FDA, he worked directly in the Office of the Center Director, Dr. Jeffrey Shuren. He was part of the FDA team that drafted the guidance document on “Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.” In 2012, his career took another leap forward when Rochester Medical appointed him as Regulatory Specialist to help the company with regulatory strategies and approval. At Rochester Medical, he prepared a Traditional 510(k) for a urological hydrophilic intermittent catheter. He focuses on helping small size and start-up medical device companies with regulatory strategies in submitting their products for regulatory approvals and marketing clearance. He also serves as Youth Director at the Ebenezer Community Church located in Brooklyn Park, MN where he mentors youth in developing their leadership skills.

510(k), Premarket Approval (PMA), and Medical Device Reporting (MDR) submission, and regulatory science, EU technical file, design dossier, and change notification, ISO standards for class I, II, and III medical devices

Mahmoud El-khateeb has completed his PhD from the University of Queensland (Queensland, Australia) in the field of analytical chemistry and he has completed his postdoctoral studies in the field of analysis and studies of Oligonucleotides from the State University of New York at Stony Brook (NY). He is currently a group leader and an acting director of analytical development R&D with Cambrex Corporation, a global specialty and custom development and manufacturing company. Dr. El-khateeb has published and presented several papers and presentations. He is recognized for maintaining compliance environment for execution critical assignments in within budget and established timelines.