IRVINE, CA--(Marketwired - Sep 4, 2014) - Enterey Life Sciences Consulting invites you to visit booth #19 at the 2014 PDA/FDA Joint Regulatory Conference in Washington, D.C., from September 8-10. Enterey consultants with proven experience in Quality and Manufacturing will be available to discuss methods to improve compliance and efficiency. The three-day conference -- which aims to connect Quality, Science, and Compliance professionals -- will highlight topics including the FDA's views on the future of manufacturing, quality and compliance in the pharmaceutical industry, and innovations to address regulatory challenges in R&D and Manufacturing.
Enterey will be represented by President/CEO Mike Ferletic, Consulting Director Austin Srejma, Consultant Jennifer Wheeler, and Business Development Leader Beth Boone.
Enterey founder Mike Ferletic has nearly two decades of experience consulting in the life sciences. In addition to project management and process improvement, Mr. Ferletic is an expert in GxP technology solutions. He has led efforts across the industry to select, validate, and implement processes around systems including Quality Management Systems (QMS), Enterprise Resource Planning (ERP), Laboratory Information Management Systems (LIMS), and Learning Management Systems (LMS). He also has in-depth experience integrating companies, sites and systems in support of mergers and acquisitions.
Austin Srejma is a consultant whose expertise centers on crafting structured and repeatable processes in Quality and Manufacturing to increase accuracy and compliance, reduce timelines, and deliver lasting organizational improvements. Her latest work has included designing and implementing a Project Management Office (PMO) for the regulatory group of a global pharmaceutical manufacturer. She recently received formal accolades from a client for delivering redesigned risk management processes and improving plant inspection readiness at a biotechnology site.
Jennifer Wheeler brings outstanding business experience in the biotechnology and medical device industries. Her current focus is on harmonizing global product release business processes for a major biotech manufacturer and facilitating the creation of new global standards documentation. In support of this effort, she has worked cross-functionally to meet internal and external requirements, assure regulatory compliance, and support the timely delivery of products to customers. Ms. Wheeler also has experience in FDA, EPA, SOX and ISO certification audits.
As an additional incentive you won't want to miss, conference attendees who visit to discuss current regulatory issues will be entered to win a top-of-the-line Go PRO Hero 3+ Black Edition™. "Go Pro" with Enterey to get zoomed in on your goals with experts focused on you.
Enterey was founded in 2002 and specializes in management consulting and process improvement for the biotech, pharmaceutical, and medical device industries. Focusing on operational excellence and project management best practices, Enterey drives value to initiatives focused on reducing risk, increasing efficiency and improving compliance.