6^th International Conference and Exhibition on GMP, GCP & Quality Control September 25-26, 2017 Chicago, Illinois, USA

Mayra has two BS, (1) in Chemistry, and (2) in Chemical Engineering from the University of Puerto Rico, and a Master of Sciences, in Thermodynamics and Materials Sciences Engineering from the University of Cincinnati, OH. She is the President of GK Regulatory Compliance Corp., and the Chairman of GK Bio-Pharmaceuticals CMO - PR a premier Bio-Pharmaceuticals Contract Manufacturing Organization locaded in Vega Baja, PR. She has a track-record of accomplishment for consistently meeting goals and delivering a high level sustained performance, proven the ability to build strong customer/client relationship including conducting vendor audits and contract manufacturing oversight. She has been a key element in the Regulatory Compliance Readiness for Major Pharmaceuticals, APIs, Biotech, Biosimilars, CMOs.

Regulatory,Pharmaceuticals, APIs, Biotech, Biosimilars

Mayra has two BS, (1) in Chemistry, and (2) in Chemical Engineering from the University of Puerto Rico, and a Master of Sciences, in Thermodynamics and Materials Sciences Engineering from the University of Cincinnati, OH. She is the President of GK Regulatory Compliance Corp., and the Chairman of GK Bio-Pharmaceuticals CMO - PR a premier Bio-Pharmaceuticals Contract Manufacturing Organization locaded in Vega Baja, PR. She has a track-record of accomplishment for consistently meeting goals and delivering a high level sustained performance, proven the ability to build strong customer/client relationship including conducting vendor audits and contract manufacturing oversight. She has been a key element in the Regulatory Compliance Readiness for Major Pharmaceuticals, APIs, Biotech, Biosimilars, CMOs.

Pharmaceuticals, APIs, Biotech, Biosimilars

Boyd L. Summers has completed his Bachelor of Science (BS), Business Administration at Weber State University, USA. Areas of emphasis: Information Systems, Production and Operations Management, Quantitative Analysis and Methods, Human Resources, Economics, Business Management and Statistical Analysis and Computer Science.He is currently working as a Software Engineer – Quality for The Boeing Company and a Software Technology Consultant for BL.Summers.Consulting.LLC located in Seattle, Washington. With 30 years of experience in Software Engineering and a leader of multiple software development teams, Boyd continues to solve complex technical challenges to ensure that system and software engineering problems are addressed, resolved and compliant. Author of the two software technology books titled; “Software Engineering Reviews and Audits.” and “Effective Methods for Software and Systems Integration. Provide Software Articles to Software Engineering Journals and magazines. Topics include: System Design, Software Requirements, Software Design, Software Test and Evaluation, Configuration Management, Quality Assurance, Process and Product evaluations. Applies Processes in Agile, Lean and Six-Sigma including a Software Technology Speaker at conferences and member of the American Society Quality (ASQ).

Quality Assurance

Dr. Zayas obtained his PhD at The Ohio State University, and postdoctoral at Princeton University in Physical Organic Chemistry. In his 31 years of pharmaceutical career, he has worked for SmithKline Beecham, Cardinal Health, Triad Isotopes, and Zaycor Industries Corp. Dr. Zayas is currently VP of Regulatory Affairs and Quality Assurance at Ionetix Corp. He has extensive experience building quality systems in compliance with Federal and International standards, for pharmaceuticals, medical device, and combination products.

Quality Assurance

Mr. Wubbolt has provided quality assurance, compliance, and computer validation consulting services since 2001, specializing in establishing data integrity programs, performing data integrity audits, vendor audits, providing training, validation, and implementing six sigma based quality improvement processes. Mr. Wubbolt has previously worked at Aventis Pasteur as Computer Validation Manager, working with GxP computerized systems. Prior to joining Aventis Pasteur, he worked at Johnson & Johnson’s McNeil Consumer Products Company in the National Quality Assurance Group and at Lancaster Laboratories. He was a contributing member of the GAMP Laboratory Systems Special Interest Group, which published the guidance document on validation of laboratory systems, as well as a chapter chair for DIA “Peach” guidance on computerized systems used in clinical research. Mr. Wubbolt is a Certified Six Sigma Black Belt, has a Masters Degree in Quality Assurance and Regulatory Affairs and a BS in Physics and Computer Engineering. Mr. Wubbolt was the previous President of both the New England Region Chapter Society of Quality Assurance (NERCSQA) and the Mid-Atlantic Region Society of Quality Assurance (MARSQA), and is currently the chairperson of the MARSQA computer validation committee.

validation, and implementing six sigma based quality improvement processes.

Mayra has two BS, (1) in Chemistry, and (2) in Chemical Engineering from the University of Puerto Rico, and a Master of Sciences, in Thermodynamics and Materials Sciences Engineering from the University of Cincinnati, OH. She is the President of GK Regulatory Compliance Corp., and the Chairman of GK Bio-Pharmaceuticals CMO - PR a premier Bio-Pharmaceuticals Contract Manufacturing Organization locaded in Vega Baja, PR. She has a track-record of accomplishment for consistently meeting goals and delivering a high level sustained performance, proven the ability to build strong customer/client relationship including conducting vendor audits and contract manufacturing oversight. She has been a key element in the Regulatory Compliance Readiness for Major Pharmaceuticals, APIs, Biotech, Biosimilars, CMOs.

Regulatory,Pharmaceuticals, APIs, Biotech, Biosimilars

Paul is a graduate from the University of Hertfordshire (UK). He is a Fellow of the Royal Society of Biology, a Chartered Biologist and Chartered Scientist. He is the managing director of PJC Pharma Consulting Ltd, a UK based consultancy firm. He has over 30 years industry experience in R&D and commercial manufacturing covering a range of products including small molecules, biologics and medical devices from candidate selection to commercialization. Paul has worldwide experience from UK, USA and Canada to Australia, Japan and Taiwan.

Paul’s interests include all development aspects especially parenteral products, sterile product manufacturing and regulatory compliance, including quality by design. He has particular expertise in cleaning qualification, verification and validation for particular for multi-product facilities.

Dr. Aziz Chraibi, PEng., is a chemical & processes engineering from ENSIACET college (1986), and then a masters at the INP of Toulouse in France. He completed a thesis doctorate at the University of Perpignan (1990) which was postulated for the best thesis of CNRS award in 1990. He developed a career of more than 25 years in the pharmaceutical and Biotechnology consulting, cGMP compliance and design review, audit and PAI (Pre-Approval Inspection) to meet Health Canada, EMA and FDA (cGMP), as well as standards ISO14644, ISO8573, ASME-BPE 2012, USP797. In 2007, he was registered as Health Canada Scientific Expert to carry out compliance audit of the pharmaceutical facilities. It has in its assets more than 120 multidisciplinary projects successfully completed in Canada, but also in the international countries, involving, audit, compliance and design review, project management, conceptual design, basic (BOD) and detailed engineering, monitoring of "Commissioning and Benchmarking", FAT, installation & strat-up, SAT, and qualification as well. Dr. Aziz Chraibi, was involved in many international congress and events as Speaker and session chair (Omics GMP Summit, in Spain September 2014, A3P & Maghreb Pharma 2013, 2014, Jordan FDA 1st International congress at Amman, Jordan)

pharmaceutical and Biotechnology,cGMP

Dr. Jixing Wang obtained his Ph.D. in Physical Chemistry at Nottingham University, England, and completed his postdoctoral research at University of Toronto, Canada. He also holds a MBA degree. Dr. Wang is currently the Senior Director of Operations at Dalton Pharma Services, a Toronto based CMO specializing in drug discovery, development and manufacturing. Dr. Wang has 20 years of experience in the pharmaceutical industry, including R&D, Quality Control, Manufacturing and Operations. He has led the research and development, scale-up and commercialization of new and generic drug products in several pharmaceutical companies. Since joining Dalton in 2013, Dr. Wang continues to lead and solve complex technical, operational and regulatory challenges facing CMOs today

R&D, Quality Control, Manufacturing and Operations

Felix Amiri is the current food sector chair of the Global Coalition for Sustained Excellence in Food & Health Protection (GCSE-FHP). He is a key contributor to the Safety, Security and Quality Assurance (SSQA) concept implementation manual published by Amiri Food Industry Support Services (AFISS). Felix also teaches International Food Safety Law and Regulations at Conestoga College. He has an in-depth knowledge of food safety and quality management systems. With more than 30 years of industry experience and an extensive knowledge of international standards, Felix serves as the Technical Director at AFISS where he provides consulting services to various food companies. He also conducts system management and regulatory audits with SAI Global. Prior to his current role at AFISS, Felix worked in product development and quality management roles with various reputable companies, including Vese Food (Nigeria) Ltd., Unifine Richardson, Golden Valley Farms, Heinz (Martin Pet Foods) and YUM Brands.

Food Safety Law and Regulations.product development and quality management roles

Professor Nikolaos Labrou received his BSc degree in Chemistry from the University of Patras, Greece (1987-1991) and his PhD in Enzyme Biotechnology from the Agricultural University of Athens (1992-1996). He has conducted postdoctoral research, as Marie Curie fellow, in Leeds UK (1996-1998) and then at Agricultural University of Athens (1998-2001). He has started his career as Assistant Professor (2002) and he is currently full Professor with tenure and Director of the Enzyme Technology Lab at the Department of Biotechnology, Agricultural University of Athens. He has authored more than 115 peer-reviewed articles in leading international journals, 26 book chapters and he has edited two books.

enzyme and protein engineering,immobilized enzymes, biosensors, drug design, protein downstream processing,microalgae technology characterization of therapeutic enzymes, proteins and other biomolecules

Rakesh Biswas is an Indian ENTREPRENEUR, Youth Ambassador of India and presently he is the Chairman of IYSERT ENERGY RESEARCH PRIVATE LIMITED AND Founder and Chairman of International Youth Society of Eco friendly and Renewable Technology and expanded his organisation across 8 countries and volunteer more than 10000 across the world, one of the strongest Youth personality in South Asian Countries. He is the Recipient of KARMAMVEER CHAKRA AWARD BY UNITED NATIONS FOR EXCELLENT Contribution in the Field of Solar Energy And SAM GLOBAL YOUTH AWARD 2014 and the Recipient of Best Suggested Project Award (Social and Quality Improvements in India) at Rhodes Youth Forum 2012, Greece in Indian delegation with Winner grant of INR 25 MILLION Indian Rupee .He has been Invited Guest Speakers and Youth Ambassador in various international Summits to represent India in Rhodes Youth Forum, Greece, South Asian Youth Conference Pakistan, Bangladesh Youth Initiative, International Summer school Croatia, IITS, TEDX and many other organisation. He has chaired many national and international conferences on renewable technology and environmental affairs.

He is the youngest person in India to have 7 patents and more than 100 research papers . He is currently working on many research projects related to Solar Paint Technology , Solar Tree Technology and solar Roads, Wind Power systems , Waste management, Social and Political Affairs, Biotechnology, Youth affairs. He delivered his famous talk on Ted Mumbai "Transformation of Youth Ideas into technology”.