However, even though I spend my days doing this sort of work I was shocked at a number that was just communicated to me in a public setting relative to FDA enforcement.

On Thursday, January 26, 2012, I attended the New York State Bar Association’s Annual Meeting in New York City, and as part of that, attended the Food, Drug and Cosmetic Law Section meeting.    As part of the regular Food and Drug Administration Update portion of the meeting, the Section was privileged to secure Elizabeth H. Dickinson, Esq., Acting Chief Counsel of the Food and Drug Administration, as the keynote speaker.   As part of Ms. Dickinson’s talk, she briefly reviewed the FDA’s recent enforcement history.

This was where the shock came.

Ms. Dickinson outlined the number of Warning Letters issued in 2009, 2010, and 2011.   The numbers related by Ms. Dickinson during her talk are provided in the table below (I have added the % increase column).

As can be seen from the numbers, FDA issued 1,720 Warning Letters in 2011 – a full 155% increase over 2010 levels.    This is also a full 262% increase over 2009 levels – an extraordinary increase by any measure.

Now, I must caveat that I have no idea whether these numbers are the final numbers that will be issued formally by the FDA for 2011 Warning Letter levels.   I further have not had the ability to directly verify these numbers with anyone else within the FDA.   However, I think a statement by the Chief Counsel in a Bar Association meeting is a public-enough forum to feel comfortable sharing this information with a broader audience.

The continuing lesson for FDA-regulated companies is that the FDA is fully-engaged, and highly-focused, on enforcement activities.    For those companies that don’t want to spend any more money on improving their quality and compliance systems because of “business” considerations, keep the following in mind:  an FDA inspection is in your future – it is a matter of when, not if, FDA will walk through your doors.   The costs of remediating compliance after the fact (and salvaging your company’s reputation, product brand equity, and loss in shareholder value) far exceeds the incremental spend on additional personnel, systems remediation and consultants in an ongoing manner.

So be careful out there – and for expert assistance with achieving best-in-class quality and compliance systems, contact Compliance Architects® at 888-REG-XPRT (888-734-9778) or Jack Garvey, Principal, at john.garvey@compliancearchitects.com.

Deep analysis of the information may perhaps shed some additional light onto particular FDA approaches or focus areas. Unfortunately, though, it is doubtful that FDA-regulated industry has much to learn from the information in the database.   In short, the database provides almost no useful information regarding the identified deficiencies that led to the classification, either good or bad. There is just very little actionable information that an industry executive can learn from the data, with one significant exception. The database information should be a reminder to all regulated industry executives that the FDA is out there, inspecting your facilities and plants, and that it is not a matter of IF, but WHEN, the Agency will show up at your door. If this leads to a better understanding of how important it is to have solid systems and processes in place, then the database will have served a significant purpose.

Unfortunately, for FDA-regulated companies, the FDA does not appear to be taking any enforcement vacations.    Because of this, companies need to remain vigilant reducing enforcement risk for the remainder of the summer.   In keeping with the season, this posting is going to be light, relatively short, and easy on the eyes.  But, don’t underestimate what I’m about to tell you.    The following can be a roadmap for significant risk-reduction within your operation, and you don’t have to spend one thin dime to accomplish any of this.

So let’s get started.

Initially, enforcement risk reduction is largely a matter of focus.    Reducing risk prospectively is a project, and in my strong opinion, should not be considered part of “base business” operations.    Organizations are generally staffed to manage base business, not to develop new or fix broken systems.    That said, you can achieve such focus with the following.

Step 1: Create a three-month, strict timeframe for an enforcement risk reduction project.    Why three months?   Well, for one thing, it’s a manageable timeframe – it is short enough to be real.   Also, three months puts pressure – and focus (which is what you want) – on your team to deliver.

Step 2: Prepare to get things done.   If you’ve got a staff of 20 people that are already overworked, you can’t just add more work to their plate.   You have to eliminate low-value work items to free staff up for a big project push.    There’s no magic here – even the best people need to go home and relax after a hard day’s work – and therefore, to focus on enforcement risk reduction, you will likely have to eliminate some other activities for the three month period.    Get your staff together for one-hour and go through and ask them what activities should be put on hold for three months so that you can achieve focus.    In all likelihood, you’ll get an earful from them.

Step 3: Turn your staff into a project-based team.    There is a big difference in how people work on routine, base-business business responsibilities, as distinguished from tight, project-focused, project-managed activities.   I personally believe that humans are “hard-wired” for project type work:    cross the river;    hunt the animal;    build the shelter;   plant the crops.     By turning your workforce from a “staff” into a focused “project team” you immediately convert passive content consumers into active content producers.

Make sure you appoint a project lead (project manager) and decompose the project sufficiently to make it manageable.   Make sure the project lead is a “can-do” type of individual that will not only get things done, but will make sure that the other people with task responsibilities get their things done!

Step 4: Conduct a hyper-critical assessment (deep dive) of your operation.   The objective here is to not provide a report for management to beat anyone up with.  The objective here is to quickly, and without attribution of fault, figure out where there is risk in your operation.    I would suggest that no names be included with the report, and perhaps, the report should not even be published or circulated.   The report should only be used as the basis for an aggressive project remediation plan.

Step 5: Review / Analyze / Triage.    Get together with your quality and compliance team in a conference room with multiple stacks of Post-It Notes, flipcharts and markers.    Take each of the findings / risk areas from Step 4 and for each finding, identify the level of risk exposure from the finding (high, medium, low) and what  specific actions and resulting deliverables can be taken to reduce or mitigate the risk within a finite 90 day window.  It is essential that you focus on activities that can be completed within the 90-day window.    Capture everything, but if it’s a longer-term remediation project, analyze it separately, after the fact.

After you prioritize the risk exposure, re-prioritize within each classification of risk exposure to get a prioritized list of activities that needs completion within the 90 day window.

Step 6: Plan.   Project management should be a core skill of any quality, regulatory or operations professional but unfortunately, it often isn’t.    A checklist or to-do list is not a plan – plans are documents that provide a roadmap – with details, resources, explanations, etc., of how you are going to get from Point A (in this case a list of things that need completing) to Point B (a list of things that are completed).

The project leader you appoint (with overall responsibility for project timing and commitments) should develop a fully-resourced project plan with realistic completion deadlines, identified predecessor tasks, and containing the prioritized list of items you identified as necessary to drive down enforcement risk.   Ensure supporting documents exist to help project members understand the project purpose, governance, support structure, etc.

Step 7: Execute.     No matter how well you plan, if you don’t execute, everything up to this point has been for nothing.   Good execution is hard – people need to focus on completing activities within pre-defined timeframes.  If they run into problems, make sure they ask for help.   I once worked for a company that told me that one of the few things that would simply be considered unacceptable was failing to ask for help if I needed it.

Track progress closely;   meet regularly and update status;    update project plans (and GANTT charts if you have them);   identify task delays that disrupt the critical path;   communicate regularly and consistently.    By ensuring you execute strictly to plan, you will walk away in 90 days with a huge level of progress, and will have reduced substantial risk.

Enforcement risk reduction is hard work.    Systems need to be remediated;   documents rewritten;   training conducted;   procedures redeveloped;  stories developed;    gaps plugged.     All this work is generally above and beyond the role of base business personnel.    By providing focus, project-based approaches, and good project execution discipline, however, your organization can begin to reduce enforcement risk without a great deal of expenditure.

Enjoy the rest of the Summer!

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For more information on how to cost-effectively reduce FDA enforcement risk for pharmaceutical, medical device and other FDA-regulated companies, please contact Compliance Architects® at info@compliancearchitects.com or at 888-734-9778.

As part of our regular communications, my friend forwarded me the following “book review” that he thought would be of interest:

Latest book from John Kotter:  “Urgency”

Essentially talks about how people/organizations need to develop “true urgency” as a core competency.  With the rate of change at an ever escalating pace, the traditional episodic approach to change (aka projects) will not be sufficient to sustain competitive advantage.  He describes three modes of operation:

1. not urgent — protecting the status quo 2. false urgency — frenetic activity ..but not aligned, goal is to stay “busy” vs winning 3.true urgency – objective is to WIN – NOW, by doing something important everyday

My reaction to this review was somewhat less enthusiastic than I’m sure he was hoping for.  It initially struck me as “consultant speak” and self-serving – something that I feel is all too common in consulting circles.    After thinking about it further, I think that much of the challenge facing FDA-regulated companies, and business in general, is that individuals within these companies don’t challenge conventional wisdom nearly enough, and simply “lap up” the concepts presented to them.   On this topic – the topic of “urgency” – I don’t think that we aren’t moving fast enough in the business world – in fact, I think we are often doing without thinking – we respond often without seeking to understand deeper issues just because we have to get a response developed, NOW!    In this context, I offered the following back to my friend:

Being the contrarian that I am, I would suggest that “Urgency” has a big price — ask Toyota or BP.    The more things change, the more they stay the same — fundamentals are key today — and failure to focus on fundamentals (culture, the long view, structural profitability, maximum asset contribution, portfolio stability and strategy, etc.) is where companies are having difficulty.   It would seem that viewing business challenges as running faster on the hamster wheel is a convenient distraction to actually achieving anything that builds long-term value.

My $0.02

Since that was a sound-bite, I’ll expand upon the principles I was trying to convey there.    I am a strong believer in robust strategy development; open, honest communication and feedback;  and comprehensive program planning and execution.     Call me old-fashioned, but I’m a strong believer in fundamentals, and this is an area that I don’t think industry, and especially FDA-regulated industry focuses on enough.

I had three high-school football coaches that taught me life lessons I still embrace today (Thank you Coach Gilbo, Coach Cotter and Coach Guyette!) , and one of the most important was the power of fundamentals.   They used to tell me that in football, every play was meant to score a touchdown – if each person executed their blocks perfectly – the play would score.  Simple.   Fundamentals.

My friend responded back;

love the spar

Fact is the world has changed…no arguing the globalization and pace of continuous change we all deal with today  — due to advances in technology, the flattening of the globe, the information access afforded by the internet…..etc

Point is urgency (action towards competing the important activities — aka those that give you advantage) must be transformed from project specific and baked into the fabric of the enterprise (CULTURE)

Too many mistake “busy” for progress.

Now, I’m not exactly sure what he meant by this, but I’m guessing he bills more by the hour than me!    Call me crazy, but I’m more in line with the ”Haste Makes Waste” camp than John Kotter’s (or my friend’s!) camp.

So, what do you think?   Are we not moving fast enough?   Or are we moving too fast?    Any comments are welcome!

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For information on how to urgently address FDA compliance deficiencies and build sustainable compliance solutions within pharmaceutical, medical device and other FDA-regulated companies, please contact Compliance Architects® at info@compliancearchitects.com or at 888-734-9778.

Now don’t get me wrong – I certainly understand the importance of CAPA, and why it is such a necessary system.     And all you have to do is read a few FDA Warning Letters or look at industry training offerings to see how significant CAPA is to the FDA, and as a result, to FDA-regulated industry.    And CAPA in its current form has been around a long time – at least since the 1996 formal effective date of the medical device Quality System regulation.     Unfortunately though, CAPA has gone far beyond being just an important sub-system that helps to resolve any one of those many, many things that can “just go wrong” for a manufacturer of FDA-regulated products.   CAPA has in recent years become the de facto cornerstone of FDA-regulated quality systems (with the expectation expanding far beyond just devices!)      Given this development, you have to ask yourself:    What does it say about the state of control within FDA-regulated industry that a system that is designed to remediate failures is now the cornerstone of most companies’ quality systems?     As troubling as the implications of this statement are, it is a topic I will leave to discuss another day.

That’s because today I want to talk about CAPA – The Untold Story.

REAL WORLD CAPA PROBLEMS

As I alluded to above, I see lots of CAPA systems.     Or better said, I see a lot of CAPA procedures.     Or more precisely, I see a lot of CAPA procedures masquerading as CAPA systems.        What I mean by that is – I see a lot of companies in their desire to have “an SOP” in place for CAPA, confusing the process of CAPA completion with the need to have a CAPA system of incident identification, analysis, categorization, evaluation, investigation, reporting, follow-up, etc.    In large part, because CAPA has become such a fundamental part of FDA’s regulatory expectations, the scope and extent of what we now call CAPA has grown along with it.    This growth in scope – by well intentioned Investigators looking to CAPA as the primary solution to a company’s problems, and by companies that are only trying to do the right thing by having a comprehensive CAPA program in place – is itself causing some of the poor outcomes with CAPA.   As scope increases, complexity often increases.    So despite the focus on CAPA – what’s wrong?   Why do many companies – solid, name companies in addition to small and mid-size companies – have such continuing trouble with CAPA? From what I see, despite this focus and good intent, there are many causes for poor CAPA system designs and compliance outcomes.  A few of these include:

1. Failure to differentiate between the CAPA system and the CAPA execution process;
2. Failure to describe in an easy to understand document or documents:
   • how the different elements  of CAPA work together;
   • how to define and differentiate trigger events; and
   • how the different elements  collectively contribute to the overall concept of control.
3. Insufficient knowledge and lack of training for SMEs on how to document, investigate, analyze, and most importantly, write-up good, understandable CAPA documents;
4. Overcomplicating the simple; and
5. Trying to make CAPA something it is not (like Six Sigma/DMAIC) or failing to understand CAPA is a regulatory requirement – not something that you can adapt to your liking in the guise of something like “continuous improvement.”

As figure 1 below shows conceptually, there are a lot of inter-related elements to a good CAPA program, and using text based documents – SOPs – to describe how these inter-related systems work, and where process begins and system ends, can be a challenge.

This is where the concept of “The Untold Story” comes into play…

THE UNTOLD STORY

So what do I mean by “The Untold Story?”    I mean – or better said I see (and this may be the biggest “duh” thing I’ve ever written)  – that many firms fail to communicate effectively in their quality and compliance documents.    And, nowhere is this more apparent than in the documents that define and constitute CAPA.

Initially, many of the CAPAs that I read are almost unintelligible!  They are filled with jargon , disconnected statements, proprietary acronyms, unsupported conclusions, data and statistics with no explanation, and often, internal inconsistencies.    Further, many companies have almost no idea of how the sub-process elements (or some would call “inputs”) of CAPA work together, much less are able to describe this effectively.      From this and a review of many other types of compliance documents (submissions, procedures, etc.)  I have come to believe that one of the most important failures in FDA compliance activities is the failure to communicate simply and effectively.

So what does this mean to CAPA?   Well, in my strong belief, good CAPA is nothing more than a good story – or better said, a series of related stories.    But why stories?     Why not a report?  Why not a quality record?   Why not an investigation protocol?    Why not a journal?

Well simply, because humans are hard-wired for stories!

It’s in our DNA – it’s in our genes.    From the water-cooler to the television;  from the dinner-table to the cinema;    from political speeches to the evening news, humans process communication best if it the communication takes the form of a story.   And with CAPA (like other FDA-required documents) why do we create these documents anyway?    Because we have to?   Well yes, but more importantly, we create them so that we can communicate – effectively – in this case to an FDA Investigator – what we do, and how we do it.

So if we want to communicate effectively to FDA, we need to communicate more stories.   We need both our CAPA system and our individual CAPAs to tell a story!

My experience has been extremely positive working with clients on this one simple concept.    Stories are actually pretty simple to write – and CAPA’s actually are perfectly adapted to follow the same basic structure:

The application of a basic, simple story structure can help you immensely improve your technical writing for FDA compliance.   Clearly though, we are not writing childrens’ novels, or even adult fiction.   There will be references to SOPs, technical details, organizational structures, complex activities, etc.  However, when you place all of these complicated elements in the structure of a simple story, it becomes so much easier to understand than if you are forced to simply read, e.g.,  fishbone diagram outlining the factors in a root cause analysis without any context.   This type of writing will help FDA Investigators understand your operation, help you to know that your SMEs and responsible CAPA authors understand the issues associated with the failure, and overall, improve your compliance outcomes.

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For information on how to build sustainable FDA compliance with world-class CAPA programs for pharmaceutical, medical device and other FDA-regulated companies, please contact Compliance Architects® at info@compliancearchitects.com or at 888-734-9778.

¹ Literary Elements (http://www.orangeusd.k12.ca.us/yorba/literary_elements.htm)

On Monday, June 21, Apple released the IPhone OS4.    This update to the Apple IPhone operating system added great new features such as multitasking, folders and more.    Also, along with this release, Apple released a great new application for the IPhone:   iBooks!

From the Apple website: “More than a great ebook reader,
iBooks is also an amazing place to browse and shop for books, day or night.”

In the original post from May 5, 2010, I advised how to get free FDA GMP/QSR Ebooks for the IPhone.   Although I thought that the instructions were pretty easy, with IOS4 and iBooks, the process of getting these is even easier! So, follow the instructions below, and check out the following FDA GMP/QSR Ebooks.    iBooks makes them look and function even better!

Let’s get started:

First, update your IPhone OS to IOS4.    This update is now available through iTunes for IPhone 3G and 3GS phones.    Next, download iBooks, which is a free download, from ITunes or directly from your IPhone or IPad using the App Store Icon.

Second, to download each individual eBook, right-click on each of the following links.   Select “Save Link As,”  and save the files, one by one, to a convenient location on your computer.    They take up very little space.   The file extension will be ” .EPUB ”

Third, launch iTunes.   Under the “Library” section of iTunes, click on the “Books” tab.    Using Windows File Manager, locate the .EPUB files in step two, and drag and drop them to the file list on the  “Books” tab.     Then, sync your computer with your IPhone and the new books will be installed as eBooks in iBooks.

Come back and get the next one when you want / need.   It’s that simple!

Dietary Supplement GMPs (21 CFR 111) Ebook

Pharmaceutical GMPs (21CFR 211) Ebook

Medical Device Quality System Regulation (21 CFR 820) Ebook

Human Food GMPs (21 CFR 110) Ebook

Electronic Records/Electronic Signatures (21 CFR Part 11) Ebook

Please consider registering with our site to be notified of new, upcoming eBooks and articles of interest.    We will use this to keep you abreast new quality, regulatory and compliance information.

What other reference documents would you like to see in this eBook format? Please let us know, and we’ll try to get them developed and out to you ASAP!

We hope you find this useful, and if you like this, please send us a note (or consider giving us a call for your compliance advisory and consulting needs!).   Enjoy!

The short answer is be prepared!

This webinar will provide background information, strategies, and approaches that will give you the best chance of success when the FDA knocks on your door!

I will be your presenter for this important 1 hour webinar!

Please go here to register:

CBI Webinar:  Inspection Readiness for a More Aggressive FDA

There is no substitute for preparedness when you are dealing with the FDA.   Do you know if you are ready for today’s FDA Investigator to knock on YOUR front door?

To get prepared for FDA inspections, or, to find out how well you would do if the FDA walked into your facility right now, please contact Compliance Architects® at info@compliancearchitects.com or call us at 888-734-9778.

Author Unknown

When you think back on your career as a Quality & Compliance Executive, how many times have you felt you had a manufacturing operation that was prepared – truly prepared – and ready for an FDA inspection?    Your walkthrough showed that the plant floor was immaculate.   Design controls were thorough.   Batch records were robust and filled out properly.   CAPAs were completed on time, and rigorously investigated.    All the calibration stickers were within their recalibration date.  Training records were complete and tied to job descriptions.    SOPs were updated.   Even the receptionist was all set with whom to call and what to do when the Investigator arrived!

Things were set!  Everything was going to go great.  You could just visualize your pride when you conveyed to the company President that you had not received an FDA 483.   Oh, that was going to be great – and even better, your bonus tied to enforcement metrics was secure.

And then comes the day when the Agency shows up.    The FDA looks at none of the things you were hoping they would look at – they looked at all these other things – unimportant things in your opinion – that had deficiencies.   They seemed to zero in on the things that would make you look bad! What happened?    Why are they looking at those things – they really aren’t that important – we build great product – consistently.    We have operators that have been here 25 years.    They know the product backward and forward – what makes it tick.    Our quality performance is good.  No recent recalls.   Now we have an extensive FDA 483 and we appear worse than we are!   What in the H*LL happened?

HACCP:   A Methodology for Defining Criticality

What happened is very simple:    when everything is critical, nothing is, and the reverse is true:   when nothing is critical, everything is!      Applying this principle in the context of FDA inspections, if you can’t convey to the Agency what is critical, and what isn’t, then your operation had better be perfect – no failures, no deficiencies, nothing wrong – because perfect is what they will expect, and we all know perfect is a very, very difficult standard to ever meet, much less consistently maintain!

There is, however, an approach – a mature quality methodology – that has been around for many years that can help FDA-regulated industry with this all-too-frequent and vexing problem.   Known best by the acronym HACCP, or Hazard Analysis and Critical Control Point, this methodology, developed by Pillsbury in the 1960s for the space program, is robust, flexible, and well established.  Using HACCP methodology (or rather, an expansion upon traditional HACCP)  a quality and compliance organization can develop product-specific quality plans, regardless of the simplicity or complexity of the product being manufactured, that tell the story of criticality, and can help address the situation presented.

At present, traditional HACCP is widely used in the US food industry, and has been credited with significantly improving the safety of high-risk foods such as seafood and low-acid canned foods in the distribution chain to the consumer.   In the context of regulated products’ manufacturing, HACCP can be expanded upon to very successfully provide improved inspection outcomes, improved operational outcomes, reduced operational costs, and a greatly overall improves state of control.

HACCP Quality Plans:  A Framework for FDA Compliance Success

Process characterization; Demonstration of control; Essential product requirements; Critical to quality; Critical control points; Risk management.

What do these seemingly disparate concepts have in common?   Together, they form a large portion of the foundation for current FDA thinking for post-approval quality expectations and basis for significant enforcement action.   As borne out by inspection after inspection, the FDA expects you to know the following about pharmaceutical, medical device, biologics, dietary supplement and other FDA-regulated products and processes:

• What are the essential product requirements, i.e., what is important about this product?
• How is the product manufactured?  What steps are involved?
• What steps and activities are critical in the manufacture of the product, or in other words, what manufacturing steps impact the essential product requirements?
• How does the operation control what’s critical?  How can the operation demonstrate a state of control?

Most documents within a company’s existing quality system are designed to address compliance with FDA expectations concerning quality system elements such as CAPA, design control, training, CAL/PM, etc.  These quality system elements are “product and process generic”, meaning, they are structured generally the same whether you are producing transdermals, capsules, aseptic fills, MRIs, tongue depressors, implantable devices, OTC  ibuprofen tablets, etc.   As a result, our traditional quality system documents fail to address the foregoing questions within the context of a particular product. In addition, device master records, batch records and other traditional product  build documentation are designed primarily to document activities after the fact. With a couple of possible exceptions, nowhere within most document systems do we maintain a document (or closely related set of documents) that provides a complete story with answers to the foregoing questions.

HACCP Quality Plans – an expansion on traditional HACCP – are developed through a multi-step process, beginning with the documentation of “essential product requirements.”   This first part of our control story outlines all of the functions or characteristics that the product is supposed to exhibit.   Sources of this information include product labeling, regulatory filings, promotional materials, product specifications, etc.

Following this step, the core of a HACCP Quality Plan can best be described as a supply-chain process decomposition.    High-level flowcharts are developed that identify the top-level process steps.  Each of these process steps are then  successively “decomposed” into a series of sub-steps, down to a very low level of granularity.  At the detail level, each step is analyzed to determine how that step could fail.   Importantly, we are only concerned here with failures that can lead to impacts to the essential product requirements, as defined previously.   Where a detailed sub-step can negatively impact an essential product requirement, we identify that step as a critical control point.

After critical control points are identified, the final and arguably most important part of the plan is the identification and documentation of the controls that have been implemented to ensure potential failures at these critical control points do not occur.   Each critical control point is separately identified, and control schemes enumerated.   Listing of multiple, differing, complementary control schemes that show how a process step is controlled is not found in any existing document set, and can convey a sense of confidence that an appropriate level of control is in place.

Finally, all of the foregoing information is consolidated into a controlled document – the HACCP Quality Plan.   The HACCP Quality Plan document should be a living, breathing document – revised and updated as changes to the supply chain occur, to reflect the current state of manufacturing control.  The document may then be used in many different ways, including:

• Defensively in an FDA inspection to demonstrate manufacturing in a “state of control”
• As the basis for a validation master plan (focused on critical control points)
• As a starting point for CAPA and other process failure investigations
• As justification for myriad quality system decisions, such as:
  • Calibration & PM frequency
  • HVAC and Environmental control programs
  • Process validation requirements
  • Training or procedural rigor
  • As an orientation and training tool

The HACCP Quality Plan methodology benefits greatly from the incorporation of operational excellence techniques, most particularly in the identification of essential product requirements and critical control points.   Familiar OpEx tools, such as Affinity Diagrams, CTQ Trees, FMEA, VOC, etc. can add considerable robustness to the underlying data presented within the HACCP Quality Plan.    HACCP is not, however, OE.   The primary objective of the HACCP Quality Plan is to tell a story – albeit an important one.   Operational Excellence is a much broader concept that incorporates many different elements.   HACCP Quality Plans can provide a great supplement to an OE-focused operation.   Most importantly, the HACCP Quality Plan can provide a solid foundation for process improvement work.

HACCP Quality Plan concepts have not been embraced widely; however, the basic principles can be adapted to individual company needs, providing a high level of flexibility for the organization.

To find out more about how HACCP Quality Plans can cost-effectively benefit your FDA-regulated company, or, for assistance in reviewing your firm’s compliance and quality systems, please contact Compliance Architects® at info@compliancearchitects.com or call us at 888-734-9778.

Although I knew Will in only a professional context, and hadn’t seen him in a few years, there were many nights  over the years where we enjoyed a wonderful dinner and shared a Sambuca or two and talked about life, family, his military experiences, and of course, business.  Will was an extremely principled man, and struggled at times, like many of us in FDA-regulated companies, at striking the right balance between doing the “right” thing and surviving in a hostile environment.   Will often made reference to his Vietnam service experience and how relevant it was in the Corporate setting.    I’m not sure which he thought was the more difficult challenge – keeping his head down in Vietnam or keeping his head down in Corporate America.

I remember Will fondly and regularly speaking of his family.   He was always very proud of their accomplishments and of the close relationship they had.

I met Will at C.R. Bard where he headed the Regulatory Compliance group.  Will was a Vice President of Quality at MedPointe Pharmaceutical in NJ for a period, and I believe his last gig was at Baxter as a Vice President.    I had been trying to locate Will to reconnect after not seeing him a few years but unfortunately, did not do so before he died.    I had heard he had made it into retirement and hopefully enjoyed some peaceful time after a life of contribution and commitment.

My thoughts and prayers are with Will’s family.      FDA-regulated industry has experienced a significant loss with Will’s passing.  He was truly one of the good guys.

A Memorial Service will be held on Friday, June 4, 2010 – 11 a.m. at the Deborah Wilson Funeral Home, 216 W est Coulter Street,  Philadelphia, PA 19144-3916

Let’s get started:

First, you have to install on your IPhone or IPad (or other compatible cell phone/PDA) the free E-book reader, Stanza, which is a free download, from ITunes or directly from your IPhone or IPad using the App Store Icon.  Also, if you are using a Blackberry or other smartphone, you can download Stanza  or another similar free EBook reader (like Mobipocket) from your own App store, or from the respective program websites.  NOTE:   The EBook reader must work with the .EPUB format.

Second, for users with the IPhone or IPad, visit this same blog post using Safari with your IPhone or IPad.  Just enter www.compliancearchitects.com/CABlog/ into the Safari address bar.

Third, when this post comes up in your browser on your IPhone or IPad, click on each of the following links, and that will launch Stanza and bring the regulations right into your Stanza library!  Come back and get the next one when you want / need.   It’s that simple!

Dietary Supplement GMPs (21 CFR 111) Ebook

Pharmaceutical GMPs (21CFR 211) Ebook

Medical Device Quality System Regulation (21 CFR 820) Ebook

Human Food GMPs (21 CFR 110) Ebook

Electronic Records/Electronic Signatures (21 CFR Part 11) Ebook

If you have a Blackberry or other smartphone, and you use a different reader than Stanza, use the following links to download the file directly and load it onto your device (right-click on the link and save on your computer):

Dietary Supplement GMPs (21 CFR 111) Ebook

Pharmaceutical GMPs (21CFR 211) Ebook

Medical Device Quality System Regulation (21 CFR 820) Ebook

Human Food GMPs (21 CFR 110) Ebook

Electronic Records/Electronic Signatures (21 CFR Part 11) Ebook

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