SOURCE: US Data Management

US Data Management

October 01, 2013 09:04 ET

USDM Strengthens Global Presence via Speaking Engagements in India; USDM's Global Audit Team to Present at Global Pharmaceutical Excellence Conference October 3-5, 2013, in Mumbai, India

SANTA BARBARA, CA--(Marketwired - Oct 1, 2013) - USDM, a leading global regulatory consulting firm in the life sciences space, has been invited to send two audit and quality systems professionals, Mr. Kevin Foley, former FDA pharmaceutical investigator, now Quality and Regulatory Compliance Subject Matter Expert and Global Auditor, and Mr. Robert Lesnefsky, V.P. of Global Quality and Auditing, to the Mumbai, India conference this October.

Both Messrs. Foley and Lesnefsky will participate alongside fellow worldwide pharmaceutical leaders in sharing key expertise on auditing quality and compliance at CPhI's "Pharma Audit Excellence" (www.pharmaauditexcellence.com). This highly-subscribed conference includes attendees and speakers from the world's largest pharma manufacturers, exporting companies and regulatory agencies.

The invitation comes as no surprise as USDM is counted upon routinely as "trusted advisors" to navigating ever-increasing scrutiny. USDM's professionals will be speaking based on extensive experience in life sciences and GxP's and regulations within the U.S. (U.S. FDA), EU (EMA) and the U.K. (MHRA). Companies represented at this talk invited include virtual pharma firms on up to growing innovators of new molecular entities to some of the biggest exporters ANDA drug substance and products manufacturers in India and China.

"I welcome the opportunity to further expand USDM's Audit experience and knowledge to the Indian Pharma space," said Kevin Foley, "I intend to use this session to offer my perspectives gained during years of experience as a former FDA Auditor/Investigator on this ever important topic to the eager audience of compliance professionals in Mumbai." 

Mr. Lesnefsky and Foley will be leading small group workshops as a follow-up to highly anticipated talks on failure investigation tools and processes, root cause analysis, interaction with regulators as well as building critical foundations for solid CAPA system.

USDM is a leading global regulatory consulting firm providing compliance, business intelligence, validation, qualification, quality, auditing, and IT services to our clients in the life sciences industries. Information Technology has evolved to become the critical backbone of a life science company that helps to produce, manipulate, store, communicate, and/or disseminate information. USDM consultants provide a variety of client services to the life sciences sector that ensure IT compliance while pushing the boundaries of IT innovation. USDM has more than 13 years of experience supplying our clients with compliant solutions in each phase of their drug and product development cycle to help companies unify and optimize their business and compliance processes. USDM provides a comprehensive enterprise solution to support US, EMEA, and Asian regulatory requirements for regulated applications.