The Enterey Blog

Risk Management. Get Your Head in the Game

Posted by Tita Tavares on Fri, Aug 30, 2013 @ 12:23 PM

Risk Management
Get Your Head in the Game

 Risk Management


Regulated industries are taxed with unavoidable risks ranging from reasonable to severe. All it takes to handle these varying obstacles is a simple mind-shift.

Risk management is the detection, assessment, and ranking of risks followed by the application of resources to minimize the likelihood of failure by the identified risk. Translation: assuming and preparing for worst case scenarios. Sounds tedious and complicated, right? Not necessarily. 

Developing a thorough plan to tackle risk management helps identify and address risks in an efficient manner. This “game plan” is best when put into action through two effective decision-making components: the approach and the preparation.

The Approach

You must have the right frame of mind when making your decisions. An open, realistic mindset is essential to approaching risk management. You must accept the fact that risks are unavoidable and be willing to take chances. The more objective and honest you are when looking at risks, the better prepared you will be to take them on.


The Preparation

After identifying all possible threats, it is important to compliment an objective mindset with comprehensive preparation. Premeditative actions you should consider are: simplifying the risk, investigating, and collecting relevant data. Thorough research will increase your confidence. Additionally, considering long term goals prior to making a decision will reduce future risks.


Putting the Game Plan into Action

So you’ve cleared your head and prepared yourself, now what? How do you organize all the information in front of you? Consider the following 5 questions and the given examples before you make your next decision:

1. What are your problem, risk, and opportunity items?

  • Below-sales forecast for products/services (Problem)
  • Unreported adverse drug events and inconsistent NDA safety database (Risk)
  • Improve clinical trial supply forecasting (Opportunity)

2. Which, if NOT pursued, erode the most value?

3. Which, if pursued, create or protect the most value?

4. Which should you pursue?

5. What are the implications to your plan and budget?


Can you, as a stakeholder in your organization, answer these questions? If so, then you're on your way to making solid decisions. These questions all lead to what we call the PRO Dilemma, a method developed by DEI. For more information, click here. 


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Published by Katie Georgi | Enterey Marketing & Communications Team  

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Tags: Risk Management, Decisions, Decision-making, Identify Risks, DEI

ICH Q8 through Q10 Guidances on Quality Impact CMC

Posted by Tita Tavares on Fri, Mar 08, 2013 @ 02:06 PM

How familiar are you with their details?
With help from FDA guidance for industry documents, Enterey extracts key
take-away information and provides a quick, downloadable reference.

Reference Guide Download

ICH Guide

Tags: FDA, Risk Management, ICH, Q8, Q9, Q10, FDA Guidance, Quality Impact on CMC, CMC, Quality, 21 CFR Part 11

The PRO Dilemma: Part 1

Posted by Tita Tavares on Tue, Oct 16, 2012 @ 04:41 PM

PRO Enterprise Management  

The PRO Dilemma: Part 1
How Does Your Company Decide
What to Pursue,
...and is it Working?


Debating & Deciding

A day in the life of a corporate decision-maker involves addressing a multitude of issues and striving to make the most of business. And, there are many styles of doing business, from conservative to liberal and free flowing with the cash. Imagine the “figure it out as we go” mentality of throwing cash at several projects to see where it will “stick” and generate profits. For most companies, though, a more calculated, safer approach is preferred. 

For companies with a sound risk-mitigation style, the decision-making process can be broken down into 3 parts: resolving problems, mitigating risks, and capturing opportunities. That is, addressing issues that arise, while trying to prevent others from occurring in the first place--all while trying to maximize profitability.

But which Problems? Which Risks? And which Opportunities should be pursued to protect and create the most value? That’s the PRO dilemma.


The PRO Plan

The Decision Empowerment Institute’s PRO risk-mitigation plan rests on the theory that the health and well-being of individuals directly influences a company’s cash flow and, therefore, a company’s health and well-being. In the life sciences, issues that can affect cash flow include poor sales due to lack of product efficacy, product recalls, safety issues, etc. In this way, quality is the backbone that supports a business and allows it to thrive.

The idea that cash is king is not new. In fact, risk-adverse businessman Warren Buffet was interviewed on Bloomberg about his interpretation of the saying, “cash flow is king.” He says he never wants to be unable to conduct a new business venture due to lack of cash flow, and the amount he like likes to keep around may be surprising.

To put it simply, it doesn’t matter how much profit is expected to come in if there’s nothing in the bank in the meantime. If you have no working capital, your business may be dead in the water. You may not be able to obtain the supplies you need to continue manufacturing, and employees will probably not hold off on cashing their paychecks until the profits come rolling in. In short, you need cash flow to maintain a healthy, vibrant business.

In the life sciences, issues that can impact cash flow need to be effectively managed. But how is this best done, given that there’s always an opportunity cost of pursing one action (ie, mitigating a certain risk or pursuing one opportunity) over another? Another known businessman, Benjamin Franklin, said it best when he coined the term “time is money.”


Putting the Plan into Action

In the life sciences, issues that can affect cash flow include clinical holds on new products, stock out from delayed tech transfer, glass-vial breakage, below-sales forecasts, and so on. Any of these things can impact cash flow by, for example, keeping a product from reaching the market on time, increasing manufacturing costs, and slowing sales. But which risks should be mitigated first, and then which opportunities should be pursued over others to create the best value?

PRO’s risk-mitigation plan paired can be used to make these determinations by asking the decision-maker to consider the following 5 questions:

1. What are your PRO items?

  • Below-sales forecast for products/services (Problem)

  • Unreported adverse drug events and inconsistent NDA safety database (Risk)

  • Improve clinical trial supply forecasting (Opportunity)

2. Which, if NOT pursued, erode the most value?

3. Which, if pursued, create or protect the most value?

4. Which should you pursue?

5. What are the implications to your plan and budget?


Can you, as a stakeholder in your organization, answer these questions? A solid risk-mitigation plan may include enlisting the help of a life-sciences consultant specializing in this area. Another way to think of this is “it takes money to make money.” Spending $300k on support staff during an NDA submission, for example, may protect $14MM in potential loss. And that’s just good business.

Join Us for A Complimentary Webinar!

Finally, A Risk Management Solution that Works!
Learn from Decision Empowerment Institute about the truth of decision making

Presenter: Brian Hagen, PhD. Risk Management from Stanford and Internationally Recognized Authority On Decision Making

Host: Tita Tavares and Rob Johnston of Enterey Life Sciences Consulting
Date: Thursday October 18, 2012
Time: 11:30 am Pacific | 2:30 pm Eastern
Duration: 45 minutes

Click here to register.


PRO Enterprise Management Methodology,
Rights of Decision Empowerment Institute
partners of Enterey, Inc.

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Next Blog
PRO Dilemma Part 2


Tags: Risk Management, PRO Enterprise Management, Decisions, Risk-Mitigation

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

Where Do We Go From Here With Our Process Validation?

Posted by Tita Tavares on Fri, Apr 22, 2011 @ 01:00 PM

What are the next steps?

Having read our first 3 blogs to become familiar with the FDA’s recent Guidance for Industry Process Validation: General Principles and Practices (January 2011), you now need to start thinking about where you and your company go from here to align your organization and process validation activities with the new guidance.

Process Validation Success

NEXT STEPS to help you: 

1. Build your knowledge base early. A successful validation program relies on information and knowledge obtained early from product and process development. This knowledge and understanding is the basis for establishing your approach to controlling the manufacturing process through continued process verification to produce products with desired quality attributes.

2. Understand the sources of your variation and the impact this variation has on your process and product. Detect the presence and degree of variation in your process. Control your variation proportionate to the risk it poses to your process and product.

3. Develop and implement a Risk Management program. Establish procedures, train personnel, and document and manage your risks in a risk management plan to reduce, eliminate, or accept process risks.

4. Use a Lifecycle Approach. Process validation activities occur over the lifecycle of the product and process from Process Design (Stage 1) to Process Qualification (Stage 2) to Continued Process Verification (Stage 3).  Science and process understanding will increase through the lifecycle.

5. Perform process monitoring to continually analyze your product and process data to ensure a state of control. This will eliminate the need for revalidation. Opportunities for process improvements can be identified, evaluated and implemented.

6. Use an integrated team approach to Process Validation. Include subject matter experts from various disciplines including process engineering, industrial pharmacy, analytical chemistry, microbiology, statistics, manufacturing, and quality assurance. Project plans with full support of senior leadership are important to success.

7. Plan and conduct all studies using sound science, appropriately documented, and approved per established procedures throughout the product and process lifecycle.

8. Develop an ongoing program to collect and analyze product and process data as required per 211.180(e). The data should include process trends and quality of incoming materials, in-process materials, and finished products, and be statistically trended and reviewed by trained personnel. A statistician or person trained in statistical process control is recommended.

9. Identify gaps in your existing process validation procedures and implement a plan to revise them appropriately to meet the expectations in the new guidance.

10. Prepare to address questions and show documented evidence to demonstrate that your manufacturing processes have been validated and are in a state of control though continued process monitoring.

Published by: Jim Anthony, Enterey| Director

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Next week’s blog:
Trends Update! Social Media in Life Sciences

Tags: Enterey, FDA New Guidance for Industry, Process Validation, Quality Assurance, Risk Management, Variation, Lifecycle Approach, Process Monitoring, State of Control, Process Improvements, Manufacturing Process, Industrial Pharmacy, Program Development, Identify Gaps, Life Sciences Industry News Life Sciences News & H