SAN FRANCISCO, Sept. 12, 2017 /PRNewswire/
ValGenesis Inc., the global leader in Enterprise Validation Lifecycle Management Solutions (VLMS), is pleased to announce the appointment of Dr. Ajaz Hussain as a member of its Board of Directors and Chairman of Advisory Board beginning September 8th, 2017. ValGenesis VLMS enables life science companies to manage their entire validation lifecycle process electronically and eliminate the use of paper in this process. Furthermore, ValGenesis VLMS enables rigorous compliance, helps to address data integrity concerns, improve consistency, significantly reducing validation cycle time and removing inefficiencies that plague paper-based validation processes.
Changing regulations, adoption of new technologies and increasing demands across geographies around Validation and regulatory compliance have compelled ValGenesis Inc. to bring forth a proactive and continuous improvement program which aims to deliver useful results. In this endeavor, Dr. Ajaz Hussain will guide and advise ValGenesis product strategy team to meet the evolving global regulatory requirements.
Dr. Ajaz Hussain brings a wealth of international pharmaceutical regulatory and business experience to ValGenesis, including his decade-long tenure with the United States Food and Drug Administration (US FDA), Center for Drug Evaluation and Research (CDER). He has led some of the US Food and Drug Administration’s major initiatives to develop regulatory policies that already have and are likely to continue to have a significant impact on product development and approval in many geographies. US FDA has honored him on multiple occasions for his outstanding contributions and innovative scientific approach to resolve complex regulatory and compliance challenges.
Dr. Ajaz Hussain is an advisor to many companies via his namesake consulting firm Insight Advice and Solutions LLC). He also currently serves as the President of The National Institute for Pharmaceutical Technology and Education, a not-for-profit educational organization which is a collaboration of 17 major universities in the U.S. Grants from US FDA primarily fund the research and training programs.
Dr. Ajaz Hussain has over 100 publications to his credit. He is a Fellow of the American Association of Pharmaceutical Scientists and the Swiss Society of Pharmaceutical Sciences. Also worked as top management with Sandoz AG in Germany and Philip Morris International in Swiss, and Wockhardt Limited in India.
“ValGenesis is excited to have Dr. Ajaz Hussain on its Board and as the Chairman of the advisory board. Dr. Ajaz Hussainis one of the architects for science-based approaches to quality and compliance at FDA. His expertise and experience as Deputy Director of FDA and as a life sciences commercial executive will help to evolve ValGenesis VLMS on par with evolving regulatory requirements and industry needs.
ValGenesis VLMS has been implemented as system records for validation process by top 10 out of 20 global life science companies. We have increased responsibility to align our product roadmap with evolving regulatory landscape to help our clients to enable/enforce the current regulatory requirements. We firmly believe that this collaboration will help ValGenesis VLMS become a de-facto standard on how Validation Lifecycle should be assured and managed across the global life science companies,” said Dr. Siva Samy, CEO & Chief Product Strategist of ValGenesis, Inc.
“As a first mover in the market, ValGenesis is demonstrating the value of the electronic validation lifecycle management system to global life science companies. Companies adopting ValGenesis are realizing significant improvement (consistency, compliance and cycle time reduction) in their validation processes. With increasing regulatory focus on science based validation, to ensure an adequate level of statistical confidence, I expect the ValGenesis software solution will be invaluable in implementing rigorous validation program. I am excited to support ValGenesis in their continual efforts in pursuit of excellence. This is an exciting opportunity to anticipate the evolving regulatory requirements and help to define the best practices for ValGenesis VLMS so that life science companies can more confidently deliver high-quality products, in time, to patients around the world,” remarked Dr. Ajaz Hussain.