The Enterey Blog

Do You Dumbo Double Dare Us?

Posted by Tita Tavares on Wed, Oct 28, 2015 @ 05:30 AM


Disney_Run_-_Team_Lemon_-_Enterey_2015.jpg

It was Magic Indeed!

Magic is what helped seven of our Enterey team members to stir excitedly awake in the wee hours of the night and get themselves to the start of the Disneyland Half Marathon weekend at the Disneyland Resort.

As part of our Enterey Gives Back initiative, our runners participated as part of Team Lemon, the endurance racing fund raising team for Alex’s Lemonade Stand Foundation(ALSF). Our team helped raise over $9000 to help ALSF and their continued fight to bring the latest technology, support, and care to young cancer patients.

The weekend of fun included the kids race, a 5k race, a health and fitness expo, a 10k race, a half marathon, and the Dumbo Double Dare. Two of our very own ambitious runners challenged themselves to compete in the 10k race on Saturday morning and the half marathon on Sunday morning. Both Alicia Mejia and Mike Ferletic finished the Dumbo Double Dare with Disney pride!

The course was lined with cheering spectators, Mickey high-fives, and live music played by local college and high-school bands. The excitement of Radiator Springs Racers refueled their energy as they came upon the halfway mark during the 10k. Once the runners flew by Soaring Over California there was no time for stopping until the iconic Cinderella’s Castle. That was a definite Kodak moment!

This past Labor Day Weekend, the mission was accomplished. Each runner set out to complete their races and they did it with smiles. Our biggest achievement, however, was the contribution made towards childhood cancer awareness. Enterey is proud to support ALSF and their efforts to be a difference-maker in the fight against childhood cancer.

If you would like to participate and take a stand with us, please consider donating to the Alex's Lemonade Stand Foundation by clicking here. Thank you for your support!

Congratulations to all Enterey Gives Back Team Lemon runners, including: Alicia Mejia, Cindy LeBeau, Deeanne Ferletic, Jennifer Wheeler, Kayleen Leong, Mike Ferletic, and Tita Tavares.

Tags: Enterey News, Enterey Gives Back

Combination Products: Adapting to a New Mindset

Posted by Tita Tavares on Wed, Oct 28, 2015 @ 05:30 AM


Client Project- Pharmaceutical Company Alignment with Combination Product and Device CGMP

In July 2013, the United States Food and Drug Administration (FDA) instigated a new regulation Current Good Manufacturing Practice (CGMP), which has significant implications for pharmaceutical and device manufacturers. Even if a company is best in industry for CGMP, the requirements apply when drugs, devices, and biological products are combined to create a combination product.

Ultimately, the CGMP alignment requires a paradigm shift in how pharmaceutical companies think about products. Although a syringe may have been previously thought as separate from the drug product, the FDA regulations now consider the product as a combination product. Thus, a new mindset is necessary, recognizing that many companies are now device manufacturers as well as drug manufacturers.


What is a Combination Product?

A combination product is a product that consists of two or more different products: a drug and a device, a biological product and a device, a drug and a biological product, or a drug, device, and a biological product. According to 21 CFR 3.2(e)[1], a combination product is defined as: 

  1. A product comprised of two or more regulated components (i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic) that are physically, chemically, or otherwise combined or mixed and produced as a single entity;
  2. Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products;
  3. A drug, device, or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug, device, or biological product where both are required to achieve the intended use, indication, or effect and where, upon approval of the proposed product, the labeling of the approved product would need to be changed (e.g., to reflect a change in intended use, dosage form, strength, route of administration, or significant change in dose); or
  4. Any investigational drug, device, or biological product packaged separately that according to its proposed labeling is for use only with another individually specified investigational drug, device, or biological product where both are required to achieve the intended use, indication, or effect.

Alignment with current FDA regulations is thereby necessary to prevent a violation of the Federal Food, Drug, and Cosmetic Act. Thus, it is critical for companies to understand the regulation as it relates to the Pharmaceutical Quality System (PQS), because the existing operating procedures need to incorporate additional elements that are unique to medical devices.

_____________________________________________________________

[1] http://www.fda.gov/CombinationProducts/AboutCombinationProducts/ucm118332.htm


Gap identification in the Pharmaceutical Quality System, compared with FDA regulatory requirements for Combination Product CGMP

At Enterey, we understand that implementing changes to an existing Quality System requires planning, time, and expertise. To avoid Health Authority action due to non-compliance, and to establish a PQS that is appropriate for the development and manufacture of combination products and constituent parts, a pharmaceutical company needs to fully assess current operating procedures in the context of the new FDA regulatory requirements. Subsequently, a transparent risk-based Quality System gap assessment determines the overall strategy to fill the gaps between the CGMP and the PQS. Depending on the high-risk focus areas, especially noting a review of purchasing controls (21CFR820.50), workstreams should be developed with the overall goal to incorporate key elements of the device regulations into the global Pharmaceutical Quality System.

To ensure full compliance with the FDA requirements as they relate to combination products and constituent parts, a company needs to implement the appropriate changes in an efficient and timely manner. A successful gap identification and remediation strategy promotes a reliable manufacturing process, which creates a harmonized global Pharmaceutical Quality System that is compliant with current Health Authority regulations. At Enterey, we find that filling the gaps not only includes supplemental Standard Operating Procedures (SOPs), but also changes the company mindset to ensure employees are trained on the rationale behind the new processes. Ultimately, the change in organizational mindset will support the incorporation and maintenance of device requirements across all documents, processes, and systems, and ensure a successful pipeline with the manufacture of a reliable product for the patient.

For inquiries on how this might apply to your business, call Enterey (800) 691-2349.



 

Tags: Enterey News, Combination Product

Employee Spotlight

Posted by Tita Tavares on Wed, Oct 28, 2015 @ 05:30 AM


Ryan Coughlin - Regional Director of Business Operations

Coughlin_Ryan_-_Web_Photo.jpg

From a background in the United States Marine Corps, with 22 years as an infantry officer, Ryan Coughlin gained his strategic planning experience in the operations management sector. During his time as Lieutenant Colonel, Ryan honed his project management credentials by working with senior executives and facilitating the leadership decision-making process.

After years in the Combined Arms, Ryan knew he was ready for a new venture. He targeted the biotechnology/pharmaceutical industry, knowing that he could apply his strategic planning background and use the same principles as military planning (with a “slight” adjustment in terminology!). Consequently, Ryan joined Enterey in 2012, and brought a new perspective to the growing company.

 

The transition to a new industry brought Ryan a well-received change. From working in the Marine Corps to global pharmaceutical clients, he continues to learn and grow every day. Ryan often quotes Winston Churchill, “Success consists of going from failure to failure without loss of enthusiasm”.

Achievements

Ryan’s greatest achievement is his ability to consistently progress through a wide range of challenges, which is driven by his keen ability to ask the right questions. Thus, Ryan ensures each team achieves the business objective by facilitating difficult discussions and applying a streamlined approach to problem-solving. In his most recent project, Ryan successfully led a project team to align cGMP for Combination Product and Devices in the client’s Pharmaceutical Quality System. This included incorporating specific elements of the device regulations into the global PQS, including the remediation of identified compliance gaps. The biggest challenge (and the greatest reward) was the change management, which required a shift in company mind-set to incorporate and maintain the requirements of device manufacturers.

Previously, Ryan led a Shipping Qualification Initiative for the same global pharmaceutical company, with the objective to ensure qualification of all shipping methods globally, regionally, and locally. Ryan identified that there were different interpretations of the Standard Operating Procedures (SOP) across the business’ network, and subsequently supported the request for project funding from the Business Management Team. Ryan managed the project through completion, with the key deliverable of responsibility handoff. More specifically, Ryan’s team enabled the individual sites to implement the SOP protocols by ensuring successful completion of the implementation planning requirements. As a result, Ryan closed out the initiative with the Business Management Team’s formal approval and endorsement of the site’s continuous operations.

As highlighted by Ryan’s project achievements, Ryan continues to build on his strategic planning experience, accepting new challenges with clients as well as internal projects. He is delighted to grow in parallel with Enterey, as the Regional Director of Business Operations in Southern California, and hopes to expand the client base in Chicago and Northern California. Throughout his career, Ryan’s unwavering dedication is consistently inspired by his love for his wife and kids, as they remain his constant motivation for all he hopes to achieve in his work and his life.


 

Tags: Enterey News

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.

 

CONTACT INFORMATION

  •  

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

Tags: FDA, Regulatory, Enterey News

Enterey Helps in the Fight Against Childhood Cancer

Posted by Tita Tavares on Fri, Aug 22, 2014 @ 11:24 AM

Enterey Helps in the Fight Against Childhood Cancer
Runs the San Francisco Half Marathon for Alex’s Lemonade Stand

 Enterey Team Lemon SF Marathon


As part of the Enterey Gives Back initiative, 8 spirited and driven Enterey employees calling themselves “Team Lemon,” ran the infamous San Francisco Half Marathon on July 27, 2014, to raise money for Alex’s Lemonade Stand Foundation (ALSF). Created in 2000 by Liz and Jay Scott, the parents of Alexandra Scott (1996-2000), a 4-year-old who battled neuroblastoma, ALSF has raised over $80 million for cancer research in Alex’s honor. Enterey set out to raise $2,000 for the cause.

In the spirit of giving back, Team Lemon laced up their running shoes and took their places among 5,000 fellow runners on the scenic, yet challenging, San Francisco course.   The route started at the Embarcadero Ferry Building and took them through Presidio to the Golden Gate Bridge, ending in Golden Gate Park.

Overcoming an injury to complete the half marathon, Enterey Consultant and Team Lemon member Jennifer Wheeler expressed feelings of relief and gratitude: “Completing the half marathon was a huge accomplishment because I doubted I could ever physically run an endurance race again.” But she pushed on, and so did the rest of the team.

“At around 22 miles, I was deliriously happy that I could still keep moving,” said Alicia Mejia, Enterey Consultant and the only Team Lemon member to run the full marathon. “But every painful moment was worth it!” In fact, the team more than doubled their fundraising goal, bringing in an impressive $5,250 toward the fight against childhood cancer!

With the success of Team Lemon in the San Francisco Half Marathon, the company plans to continue the Enterey Gives Back campaign. Enterey CEO and Team Lemon participant Mike Ferletic acknowledged the team, saying “I was proud of our fundraising team for their efforts, which led to a contribution of over $5,000 to ALSF in our inaugural event, and I look forward to continuing our support of ALSF's efforts to find cures for childhood cancers.”

Join us as we continue to raise money for the Alex’s Lemonade Stand Foundation by visiting Enterey’s Team Lemon website!

Click here for latest industry news.
Published by Enterey's Marketing & Communciations Team

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Tags: Enterey News, Enterey Gives Back, Alex's Lemonade Stand, Enterey Team Lemon

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

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

Top Priorities of a Successful Inspection by Mark Tucker

Posted by Tita Tavares on Fri, Mar 09, 2012 @ 08:56 AM

All companies talk about conducting successful inspections but how many have clearly defined what a successful inspection is?  In this blog, I will talk about what I feel are key attributes in order for a company to deem their inspections a success.  

Inspection 

First and foremost, a successful inspection must allow you to obtain or maintain your right to manufacture and distribute a product.  Whether this is your first pre-approval inspection or a general GMP inspection, there are significant consequences for failing to get approval or to be found “out of a state of control.”  The inability to sell and market products caused by a failed PAI GMP inspection, affects not only your bottom line but the patients that need your products. 

The second priority for a successful inspection is to avoid less severe but still damaging regulatory or market actions, which include product withdrawals, product recalls, warning letters and even seizures.  While not as severe as losing the right to operate, these actions still affect the company financially by potentially causing a loss of revenue, a loss of market share, and a loss of stock value while also damaging your company’s reputation and opening the possibility for litigation.  

The above two priorities are critical to the success of the company.  However, there are other, less critical but still important, goals for managing inspections.

Minimize the number and scope of the findings:  I believe that many companies err in making this a critical outcome for an inspection to be considered successful.  While this goal is certainly important, it is more important in my mind to look at the bigger picture.  While you definitely want to minimize the number, scope and significance of findings, in some instances, it might be better to accept a finding rather than to continuing to “discuss” the issue during the inspection.  Inspectors are human, too, and if they feel you are arguing without merit (and if the goal is zero observations, this can occur), the tone of the inspection can be negatively impacted harming your ability to influence the outcome of a more significant issue later in the inspection. 

Maintain the confidence of the health authorities: You can damage your image with health authorities by the way you handle an inspection. Regardless of the outcome of the inspection, you need the health authorities to perceive you as being open and cooperative rather than closed and secretive. You need the health authorities to feel your company is committed to quality and doing “the right thing.”

Have few or no surprises during an inspection: If you have implemented a robust inspection management system that includes regular updates to Senior Management,   no one should be surprised by the inspection findings and outcome.  However, if there are surprises, it is important to review and assess your inspection management system to understand where there are still gaps and improve the system to try and ensure there is no recurrence.

Maintain good inspection logistics: By implementing a robust inspection management system, there should be good communication between the inspection room and preparation rooms.  Documents should flow smoothly and as requested after being appropriately vetted; presenters should be well-trained and informed of the current issue under discussion before interacting with the inspectors; and the right people should be available at the right time with the right information.  If you do this really well, you can minimize the effect of the inspection on your site’s operations. 

By defining what a successful inspection is for your company, you can ensure everyone is working together to meet those goals, which in turn, will increase the probability of having a successful inspection outcome.  At Enterey, in partnership with Mark Tucker, LLC, we can help you in all aspects of inspection management to help ensure you meet your inspection outcome goals.

Comments?  Questions?  We want to hear from you.

 

Click here for latest industry news.
Published by Mark Tucker | Inspection Management & Auditing Expert, Enterey and Mark Tucker, LLC


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More on great Project Management


Tags: Enterey, FDA, Inspection Management, Inspection Readiness, Inspection Management Systems, Mark Tucker, Enterey News, Drug Manufacturers, Life Sciences Industry News Life Sciences News & H, Communication, Pharma, PAI, Pre-approval Inspections

Process Improvement Award Winner with Global 500 Biotech Company

Posted by Tita Tavares on Thu, Feb 23, 2012 @ 10:58 AM

 

Austin Srejma Enterey Senior Consultant

Austin Srejma, Enterey Senior Consultant

 

"Enterey Project Wins Process Improvement Award From Global 500 Biotech Company"

See how we introduced a more efficient change control process to help the growth of a current biotech client. Congratulations to Austin Srejma for being awarded a process improvement award. 

"Austin Srejma has served as Senior Consultant with Enterey since July 2009. This is the second time one of her projects has received a process improvement award. Enterey Life Sciences Consulting, founded in 2002, provides Life Sciences Consulting expertise across both process and system-related projects. Enterey provides solutions for a wide range of client needs, from strategic planning to business-integration activities, implementation and specialized efforts, such as clinical and commercial facility start-ups. Enterey has a proven track record for successfully delivering projects within the biotech and pharmaceutical space"

Read further current press details highlighted in LA Daily News.

 

 



Tags: Enterey, Enterey News, Life Sciences News & Hot Topics, Facility Start-up, Life Sciences, Process Improvements, Life Sciences Communication, Life Sciences Consulting

4 Rules to Facility Start-up. Looking Deeper Into Rule #3

Posted by Tita Tavares on Wed, Aug 10, 2011 @ 12:25 PM

Rule #3: A deeper look into facility start-up.

--------------------------------------------------------------- 

Remember Humpty Dumpty”

Now I’m sure you’re wondering what this rule has to do with facility start-ups, but before we go down that path let’s start with a simple exercise: draw Humpty Dumpty.  Go ahead, get out a sheet of paper and draw Humpty Dumpty.  It doesn’t need to be a masterpiece, just draw what you think of when you hear Humpty Dumpty…I’ll wait.   How many of you drew something that resembles an egg?  Before we go further, go ahead and read the typical version of the nursery rhyme “Humpty Dumpty”

 

Humpty Dumpty sat on a wall,
Humpty Dumpty had a great fall.
All the king's horses and all the king's men
Couldn't put Humpty together again

Facility Start-up


After reading the rhyme, I’ll ask a simple question, where does it say that Humpty Dumpty is an egg?  Obviously it doesn’t but we’ve been trained to think of Humpty Dumpty as an egg because someone drew him/her/it (I’ll use him for ease) that way many moons ago.  If you didn’t draw him as an egg; bravo!  I know I would have drawn him as an egg.  The point I’m trying to make is that it is important not to set artificial boundaries, particularly when trying to solve a problem.

 

 

During facility start-up the only thing you can count on is that things will change.  Issues will arise that are unexpected and that will require creative solutions.  When trying to come up with a solution just remember; Humpty Dumpty does not have to be an egg.  In other words, question everything and don’t set artificial boundaries for yourself.  Life sciences is already a regulated industry and you certainly don’t need to add more “artificial” regulations.

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Published by Carlo Odicino | Former Director, Client Services

 

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Next week’s blog:
4th Rule of Facility Start-up

Tags: Enterey, Enterey News, Life Sciences Industry News, Facility Start-up, Life Sciences Industry News Life Sciences News & H