The Enterey Blog

Meet With Enterey's Quality Experts at 2014 PDA/FDA Conference

Posted by Tita Tavares on Thu, Sep 04, 2014 @ 11:24 AM

SOURCE: Enterey, Inc. Life Sciences Consulting

Enterey, Inc. Life Sciences Consulting

September 04, 2014 13:37 ET - Live on MarketWired

Meet With Enterey's Quality Experts
at 2014 PDA/FDA Conference

The Exhibitor at Booth 19 With a Giveaway You Won't Want to Miss

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.




    Tita Tavares
    Enterey Life Sciences Consulting
    (800) 691-2349
    Email Contact

Tags: FDA, Regulatory, Enterey News

The Importance of Scheduling Facility Maintenance Shutdowns

Posted by Tita Tavares on Fri, Dec 09, 2011 @ 11:30 AM

We’re all aware that we need to perform periodic recommended maintenance on our vehicles, such as oil changes for our cars every 3000 miles. What’s the worst that can happen if we skip these?  A potentially hefty repair bill at the mechanic shop if not caught in good time, or the worst case scenario – the annoyance of a breakdown on the side of the road.

 Facility Shut Down  

Similar to our cars, manufacturing facilities require periodic maintenance.  Most facilities are shutdown every 6-18 months to perform preventative maintenance or repair tasks on facility and utility systems.  What’s the worst that can happen if these are skipped?  There’s probably no significant damage to systems if caught in relatively short time.  But despite the low risk, there is a possibility of failure of equipment and systems when operating outside of the manufacturers’ recommended maintenance intervals.  These repairs can cost a significant amount of money, cause facility downtime, and most importantly potential contamination or loss of product. Most importantly, it will also require a resource draining assessment of the impact to manufacturing processes and products.  

Knowing this, the U.S. Food and Drug Administration requires that facilities and equipment be maintained and kept in good repair in 21 Code of Federal Regulations (CFR) Part 110.  One manufacturer, a pharmaceutical manufacturing facility in North Carolina, who ignored this warning learned the hard way when in November of 2007, they underwent an inspection by the FDA.  The inspector found environmental monitoring excursions in the purified water loop dating back to February and March of 2007 – eight months earlier. 

While the company noted that a modification to the purified water loop would correct the problem, the necessary parts had not been ordered or installed.  In fact, the company waited until June 2008, during the plant’s semi-annual plant maintenance shutdown, to install it.  In the meantime, production was compromised by this and other issues which they failed to address or rectify.

As a result of this and other significant violations, the FDA issued a warning letter and advised the company to take prompt action to correct all deviations. Failure to do so would result in regulatory action including seizure and/or injunction.

Had this company taken the necessary steps to schedule the maintenance and modification of their purified water loop during their annual or semi-annual plant maintenance shutdowns, they could have identified issues causing the environmental excursions, then successfully taken corrective action.  Their inspection would have gone smoother and they could have avoided receiving the dreaded “483 - FDA Warning Letter” and the prospect of fines, penalties and expensive repairs.

Most importantly, they would not have compromised their manufacturing facility with potential contaminants which could lead to risks for patients, loss of contracts, the destruction of inventory, and a public relations nightmare.

By scheduling periodic facility maintenance shutdowns, complete preventative maintenance designed to improve equipment life can be performed along with any modifications and system updates.  With the appropriate time afforded for a shutdown, operations can be expected to run at the greatest efficiency, eliminating or minimizing the need for unplanned facility downtime.

To ensure the longevity of your operations, schedule your facility maintenance shutdowns. You’ll sleep better knowing that all systems are on track.


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Published by Murtaza Kapadia | Senior Manager, Enterey


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Next week’s blog:
A Look at What Happens Behind the Scenes of a Plant Maintenance Shutdown


Tags: 483 FDA Warning Letter, Corrective Action, Facility Maintenance Shutdowns, Facility Maintenance, Regulatory