The Enterey Blog

ENTEREY LIFE SCIENCES CONSULTING WELCOMES BACK A FORMER CONSULTANT

Posted by Tita Tavares on Thu, Jun 20, 2013 @ 11:04 AM

Irvine, California (March 05, 2013) – Enterey Senior Director of Operations, Carlo Odicino, returns to the life sciences consulting company after working in the field for a biotech company and a medical device manufacturer. He explains how the hands-on knowledge he gained primed him for his return to Enterey.

“My job at Enterey is to ensure the quality and consistency of the work from our consultants,” says Odicino. “It is much more valuable to have, or to be, a consultant who understands how things run on a day-to-day basis from the client perspective. The more we can put ourselves in our clients’ shoes—the more we have lived what they live—the more effective we can be.”

“I was driven to go out into the field to continue learning, build teams, and have ownership of internal strategic projects. I did that, and then I realized that the knowledge I gained could be highly useful to Enterey, so I came back,” he explains.

According to Inc. Magazine, rehiring a former employee is a “much more informed decision on both [sides].” Also, because there is little recruiting and vetting effort with a former employee, there are direct time and cost savings.

Knowledge retention is another benefit of embracing a past employee. This idea is aligned with the Lean Six Sigma methodology of Enterey and its partner, Lean Training and Consulting, Inc. And Odicino puts the Lean Six Sigma principles to work for Enterey clients. “Lean Six Sigma helped me when I worked in the industry, and it helps us now in consulting,” he says. “Lean Six Sigma is a powerful tool set and problem-solving methodology that is highly effective when applied to situations  appropriately. It is not a ‘one-size-fits-all’ solution. When we help train a client’s workforce to become more efficient, they’re able to increase output and improve quality, while maintaining the same size staff.”

“Meeting expectations isn’t good enough,” he says. “We need to exceed expectations in every single engagement. And we do this by paying attention to detail. We commit to the training of our consultants, and standardize both our delivery methodology and our tool set. I call it ‘The Enterey Way,’ and it means serving our clients in a consistent manner that consistently exceeds their expectations.”

“I’m excited to welcome Carlo back to the Enterey team,” says Enterey CEO Mike Ferletic. “His addition to our team will allow us to further increase our focus on high-quality service delivery and improve support to our consultants, and ultimately to our clients. Carlo’s experience working both as a consultant and as a client make him uniquely positioned to take on this role.”

 

Enterey Life Sciences Consulting provides consulting expertise in both business process- and systems-related projects for biotech, medical device, and pharmaceutical clients. Enterey provides solutions ranging from strategic planning to business integration, and has a proven track record of success supporting both clinical and commercial facility start-ups.

 

Contact Enterey at (800) 691-2349 or visit http://www.enterey.com for more information. 

 

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Tags: Enterey News, Product Lifecycle, Lean Six Sigma

What Are the Differences in the New Process Validation Guidances?

Posted by Tita Tavares on Thu, Apr 14, 2011 @ 04:40 PM

  Enterey Process Validation Differences

 
What should you be doing differently?
  

There has been an FDA industry paradigm shift, with which you will need to align. Provided below is an easy reference table pointing out key elements of FDA’s Guidance for Industry Process Validation: General Principles and Practices (January 2011), some of the differences in the new guidance, and the areas of focus for FDA during their next inspection of your facility as it pertains to process validation.

Take a look at how these modifications could influence today’s current practices.

FDA Guidance for Industry
Process Validation: General Principles and Practices (2011)

Scope includes entire Product and Process Lifecycle

Decisions are based on Sound Science and Risk Management

3-Staged Approach to Process Validation:

1)       Process Design

2)       Process Qualification (PQ)

3)       Continued Process Verification

Emphasis on Process Design – Process design is dependent on process knowledge and understanding obtained; testing to failure is not required or expected; studies are conducted with sound scientific methods and principles, including good documentation practices

Process Qualification (PQ) differs from 1987 guidance - Process Performance Qualification (PPQ) is milestone in product lifecycle prior to commercial distribution; PPQ  is based on sound science, product and process understanding, and demonstrable control

Emphasis on Continued Process Verification and Process Control – Process knowledge and understanding is basis for approach to process control; ongoing program must be established to collect and analyze product and process data, trends, quality of incoming materials, in-process material, and finished products

Statistics – Statistician or person with adequate training in statistical process control to develop data collection plan for Continued Process Verification, statistical methods and procedures to measure and evaluate process capability, intra-batch and inter-batch variation is recommended

Revalidation and Retrospective Process Validation has been eliminated with Continued Process Verification

There is no magic number of required lots or runs in PPQ;  a documented justification and rationale that assurance is achieved and the process is in a state of control is stated in the PPQ Protocol Execution and Report

Level of PQ effort, documentation, testing, degree of control over attributes or parameters during Continued Process Verification, etc. are all commensurate to the level of risk to the process or product

Publishe by: Jim Anthony, Enterey | Director

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Tags: Enterey, Enterey News, FDA New Guidance for Industry, Process Validation, Process Verification, Process Qualification, Reference Guide, Process Design, Statistics, PPQ, PQ, Product Lifecycle, Process Lifecycle, Differences in Process Validation Principals and P