The Enterey Blog

Enterey News September 2012

Posted by Tita Tavares on Thu, Sep 20, 2012 @ 03:18 PM


Community Corner

Enterey Community Corner

Helping Those In Need Get Dressed to Impress

At Enterey, our business is providing growing life sciences companies with operations solutions that allow them to focus on what they do best. As a company-wide initiative, we also like to focus on doing our best, not just with the services we offer but also for our community. Partnering with companies like Robert Half International—an organization that has helped over 5,000 people return to the workforce after poverty, abuse, or military duty—our contributions become even more impactful. 
Last month, Enterey participated in Robert Half’s suit drive benefiting Working Wardrobes of Orange County. The goal was to collect donations of professional attire and accessories to help empower people of all backgrounds to confidently enter the workforce and achieve self-sufficiency. With the help of our friends and family, we donated everything from well-kept designer suits to bags full of barely worn shoes, all of which will soon help people seeking employment get “dressed to impress.” 
Thanks to Office Team Laguna Niguel, a Robert Half Company, for allowing us to participate in this initiative and make a difference in our community.

What's in The News for Enterey?

Enterey Consulting Partners With DEI to Support the Creation and Protection of Shareholder Value for the Life Sciences

Enterey DEI Risk Management 5
IRVINE, CA--(Marketwire - Sept 05, 2012) - Enterey Life Sciences Consulting, a leading provider of consulting services focused on manufacturing and quality operations for life sciences companies, introduces Decision Empowerment Institute (DEI) PRO-Enterprise Management Risk Quantification Approach for assessing operational and compliance risk, resulting in a sustainable risk-mitigation strategy and protecting potentially billions in shareholder value. 




Risk Management Seminar with DEI - October 4, 2012 at 11:30 am

Can you, as a stakeholder in your organization, answer the following "Five Questions" related to your company's problems, risks, and opportunities (PRO)? Find out why you should be concerned and learn how to prioritize your risks. Registration information will be announced soon. 


8th Annual Quality & OPEX in Pharma & Biotech - Frankfurt, Germany | October 4-5, 2012

Enterey CEO, Mike Ferletic, will present a Case Study on The Importance of Proactive Compliance and Preparing for GMP Inspections.

Register for the conference >>


Project Update: Consultant Assists in Successful PAI to Support Commercial Launch

A small drug-development company in Southern California set out with the goal of acquiring a commercial license for its oligonucleotide manufacturing facility in 2012. See how the Enterey consultant was able to assist in a successful European PAI to support the client's commercial launch.

View details >>




Project Update: Tech Transfer Leads to Spend Analysis & Increased Utilization

A prominent biotech/pharmaceutical manufacturer requested assistance in transferring its clinical manufacturing capabilities to a newly commercialized facility. Read more about how Enterey's consultant led the client to refrain from a site closure.

View details >>


Tags: Enterey News, Life Sciences Industry News, Life Sciences News & Hot Topics, Quality Risk Managment, Risk Management, Life Sciences, Proactive Compliance

PROACTIVE COMPLIANCE. How Does Your Organization Define it?

Posted by Tita Tavares on Tue, Aug 28, 2012 @ 01:18 PM

How Does Your Organization Define it? 

Generally speaking...
A Google search of the term “proactive compliance” results in a multitude of definitions. Wikipedia distills the term down to a simpler “proactive,” which it defines as: organizational behavior that is anticipatory, change-oriented and self-initiated, particularly in the workplace. Australia’s Department of Commerce even has a consumer-protection, proactive-compliance program designed to, among other things:   

Enterey Proactive Compliance 
  • Promote a culture of compliance by assisting agencies

    to understand and comply with legislative framework

  • Promote the use of compliance tools

  • Encourage high levels of industry best practice

Symantec, the world’s largest maker of security software for personal computers, takes an IT-oriented approach and states in their 2009 white paper that “proactive compliance describes an innovative...way of thinking about...compliance with industry regulations and standards.... Rather than focusing exclusively on the immediate need to pass an audit, proactive compliance entails looking beyond the audit and leveraging compliance efforts to drive (IT) operational excellence.” The paper goes on to admit that “unfortunately, for most organizations the reality is quite different. [With] regulatory requirements, tight budgets and limited resources, many companies adopt a highly reactive approach to compliance.”  

How Enterey Defines It

In May 2012, Enterey presented an interactive educational session on pre-approval inspection (PAI) readiness with input from former FDA inspector, and current Enterey partnering consultant, Mark Tucker, PhD. In this session, attendees spoke to their own pain points with PAI, and Enterey presented a successful PAI case study and illustrated the 5 essential questions every organization should ask prior to inspection.  

Tucker defines proactive compliance as “identifying potential problems before they become real problems.” He says that in traditional compliance, an audit is conducted and the findings are analyzed after the fact. But in proactive compliance, an audit is still conducted but processes are reviewed before they are executed, potentially eliminating and findings and saving a lot of time and re-work.  

In October of this year, Enterey CEO Mike Ferletic will give a presentation on proactive compliance in Germany at the 8th annual Fleming Europe meeting on Quality Operational Excellence in Pharma Manufacturing.


Creating Your Organization’s Definition

So, what does proactive compliance mean to your organization? If your organization is involved in R&D, it means changing the way you approach FDA audits and inspections. It means being compliant with regulations, anticipating and addressing any “skeletons in the closet” that could potentially come up in an audit and restructuring the company culture so that you can be ready--instead of reactive--for an FDA inspection.  

According to Tucker, proactive compliance has several other advantages, including:

  • A competitive edge, saving a time that would otherwise be spent on deviations, investigations, re-works, etc. 

  • Partnerships between operations and quality; those involved in quality gain a better understanding of business, and those involved in operations gain a better understanding of quality, building better leaders.

  • Increased company pride and morale.  If a company is constantly striving to be better--which is at the core of proactive compliance--then a company will make a better product, and employees will be proud of that product.

Are You Ready?

When the Parenteral Drug Association has its annual PDA/FDA joint regulatory conference in September of this year, will PAI be on your mind? Will you be engaged in proactive compliance and ready for anything the FDA might request? Or will you still have lingering questions that could ultimately impact your bottom line? 


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Published by Mark Tucker | Enterey Partner 

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Tags: FDA, Inspection Management, Inspection Readiness, Proactive Compliance, Quality Risk Management, PAI