The Enterey Blog

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.

 

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Published by Mark Tucker | Inspection Management & Auditing Expert, Enterey and Mark Tucker, LLC


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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

Facebook and the Pharma Industry

Posted by Tita Tavares on Thu, May 26, 2011 @ 03:17 PM

 Purple Social Media Enterey Blog6 resized 600

Is Social Media
that Important to Pharma Companies?

 

As a follow up to our May 5, 2011 post, Pharma, Social Media and the FDA's Delay, here's an interesting development that just might help push pharma companies to stay on top of the FDA to issue further guidelines on the industry's interaction in the social media world.

By August 15th, Facebook will require pharmaceutical companies to enable and allow public comments on their posts. This could be a huge risk and may be a big problem for pharma marketers, posing whether or not the benefits of Facebook are worth the effort.

Basically, it will take a lot of monitoring to make sure the conversations and dialogues on their company pages remain in a positive light for the manufacturers. Will this solution be cost prohibiting or will it be minor when weighed against the benefits and attraction Facebook interaction creates?

Is this decision made by Facebook a good one or not? This type of action may be what the social media mogul needed to keep their brand and product consistent all the way through. Facebook is created to be a virtul forum for real conversations to take place. It allows people to interact in the comforts of their own environments. Taking away the ability to engage in a virtual dialogue would be like telling someone, "Let's talk but do not say anything. I am the only one allowed to talk here but please listen." That isn't much of a conversation anyone would want to engage in, virtual or not!

Though Facebook's policies may be a hurdle for pharma companies and their marketing teams--if they play it right--they should be able to leap easily over the challenges and continue to use the virtual platform as a vehicle to set a casual tone in relating to their customers and patients. The informal approach could lead to patients feeling like they really matter to these seemingly HUMONGEOUS companies and at that, patient loyalty would be well worth the effort.

Read Article   

From stacyrobin on twitter: New realities for pharma? RT @kbkcomm: Hmmm...@Facebook says: pharmas must enable comments by August 15 http://ht.ly/52X6q (http://twitter.com/stacyrobin/statuses/73827493462806529

To get a better understanding of Facebook’s policies towards the pharma industry, read Intouch Solution’s Blog for their view and comments.

Published by: Tita Tavares, Enterey | Director, Brand Development


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Tags: FDA, Life Sciences Industry News, FDA guidelines, Social Media, Communication, Social Media and Pharma, Facebook, Risks, Life Sciences Communication, Pharma Marketing

Pharma, Social Media and the FDA's Delay

Posted by Tita Tavares on Thu, May 05, 2011 @ 12:40 PM

Is Pharma at a HALT with Blogging, Sharing, Posting and Tweeting Because of the FDA’s Delay of Its Social Media Guidance?

Enterey FDA and Social Media


We’re into the second quarter of 2011 and the hotly-anticipated guidance document has yet to be seen. What should the industry be expecting?

From what I can tell after checking our company’s Enterey Twitter page, Pharma social media is alive and well but under what direction are they communicating with the online community? Are they putting themselves at risk or is there opportunity that the FDA is holding them back from by delaying this process?

The FDA had been expected to issue a draft of guidelines in the first quarter of this year, but the deadline has gone and went. The purpose of these guidelines is to give the Life Sciences industries direction on how they interact and communicate through social media platforms with physicians, allied healthcare professionals and consumers due to the immense amount of information available and the potential threats that arise from this very informal line of communication.

In the Consensus Interactive presentation given back at the FDA Part 15 Public Hearing on November 15, 2009, it’s stated that the Pharma industry is at a crossroads with the modern development of Social Media. The FDA needs to act now in support of the industry taking advantage of the growth benefits and tremendous opportunities that just may be passing them by. It’s been almost two years later since the hearing.

Rohit Bhargave of 360 Digital Influence, gives a well-dressed commentary on what we can expect from the US regulator in regards to this ever changing challenge of social media and affects on the world of Pharma. For further details, read his explanation to see how this might just change your future blogging, sharing, posting and tweeting.

Published by: Tita Tavares, Enterey | Director, Brand Development
 

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Next week’s blog:
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Tags: FDA, Life Sciences News & Hot Topics, Social Media, Interactive, Communication, Pharma