5^th International Summit on GMP, GCP & Quality Control August 12-13, 2016 Toronto, Ontario, Canada

Rama K Pidaparti has over 25 years of industry experience. He has a M.S in computer science and Healthcare and Life Sciences courses from Sloan School of Management. He has worked on regulatory compliance aspects from concept to post market, at multiple Life Sciences businesses such as GE Health care, Boston Scientific, Medtronic, Zimmer, Johnson and Johnson, Genzyme, Genentec, Millennium Pharmaceuticals. He is a seasoned speaker on Compliance related topics at Life Sciences events.

Advisory Management Consultant in the IT, SCM, R&D, QA-RA & Compliance space for the LifeSciences & HealthCare sector

Daniele Rubert Nogueira is a postdoctoral researcher at Federal University of Santa Maria (Brazil). She received her Master degree in Drug Quality Control from Federal University of Santa Maria (Brazil) in 2009 and then the Ph.D. degree in Pharmaceutical Sciences from University of Barcelona (Spain) in 2013.

Her research focuses on in vitro toxicology, nanotechnology, drug quality control and validation of analytical methods. She has published more than 35 papers in reputed journals.

Kenneth Christie has over 30 years of sterile manufacturing and regulatory GMP consulting experience in the areas of Quality Assurance and Validation Management in the pharmaceutical and biotechnology industries. Mr. Christie was the Validation Manager at Parke-Davis' Sterile Products Facility where he was involved in the review and approval of all facilities, equipment, and system commissioning/qualification activities. He had routine interaction with the FDA and European inspectors (EMEA), corporate management and third party contract-manufacturing representatives. Mr. Christie is a speaker and trainer for several professional organizations in the US, Canada, Europe, and Asia and is a published author of several articles dealing with the challenges of aseptic processing. Additionally, Mr. Christie served as a member of the ISPE’s Professional Certification (PCC) Commission as an Examination Development Committee (EDC) member.

Kenneth Christie responsibilities include quality system auditing, GMP training, and serving as a subject matter expert for aseptic manufacturing processes, equipment and utilities, medical devices, and solid dosage processes on a global basis. Mr. Christie also performs vendor audits, site pre-approval inspections and assists clients with addressing and correcting regulatory observations.

Mohammed R Khan is a Quality Management Consultant and Principal, Synergex Consulting, Canada. He has earlier directed the QA/QC and Regulatory Compliance operations at DuPont Pharmaceuticals Canada, and served on the Board of Directors at the Pharmaceutical Manufacturers Association of Canada / Plant Operations Section. As an active member of the Drug Information Association, he has served on the DIA Advisory Council of North America, Chaired the DIA Canadian Programming Steering Committee, and was responsible for initiating and establishing the DIA’s Annual Canadian Meeting. He has also served as Program Coordinator, Program Committee Member, Session Chair and Speaker at numerous DIA events spreading over the US, Canada, Europe and South Asia, and is a recipient of the DIA Outstanding Service Award. He is a Senior Member of the American Society for Quality (ASQ) and also a Member of the Pharmaceutical Sciences Group (PSG) Canada. He has served as Presenter for the Parenteral Drug Association (PDA) in Europe and Japan, for the OMICS Group nationally and internationally as Organizing Committee Member and Speaker, and as a Presenter for the PSG Canada, International Quality and Productivity Center (IQPC) USA, UK based International Society of Ethnopharmacology, and the annual Indian Pharmaceutical Congresses.

Quality Management and Pharmaceutical Sciences.

Dr. Boyd L Summers has completed his BS degree at the age of 34 years and is a Consultant for BL.Summers.Consulting.LLC in Seattle, Washington. With 30 years of experience in Software and Systems Engineering and a leader of multiple development teams and consultation requests. He continues to solve complex technical challenges to ensure quality problems are addressed, resolved and consistent for business companies and institutions for future and effective operations. Author of two books titled; Book (1) Software Engineering Reviews and Audits will improve individual and companies and institutions the efforts in maintaining professional settings to develop for profit, cost reduction, and service quality improvement. Book (2) Effective Methods for Software and Systems Integration show order to develop, operate, and maintain quality capabilities inside work product facilities and companies. He has publish many quality articles and is a speaker at conferences related in the importance of quality.

Vision: Quality is inclusive for creating a community working together and establishes an inspired future for employees and customers for companies and businesses. Mission: Drive the growth of our people and our business through personal and professional development focused on disciplined execution and quality. Quality Assurance Audit Steps are: Quality Planning Perform Audit & Evaluations Record and Report Audit & Evaluation results

Wael Ebied has completed his BPharm from Tanta University with Postgraduate studies from Al-Azhar University School of Pharmacy. He is a certified Senior Professional, SQA Services Inc., US leader in providing supply chain management, quality and engineering services to pharmaceuticals, medical devices and highly regulated industries. He has published many papers in reputed journals and has been serving as an Editorial Board Member of repute. He has more than twenty years’ experience in pharmaceutical industries, biotechnology, medical devices and APIs. He is an accomplished technical presenter with numerous projects, scientific publications, participated in some patents and was awarded many premiums.

Pharmaceutical Industry, GMP, GCP, QC, Regulatory Affairs, Drug Delivery, Biopharmaceuticals, Generic Pharmaceuticals, Natural Products, Nanomedicine & Drug Formulation.