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Deputy Assistant US Attorney General Outlines New Approaches for Enforcement of FDA-Regulated Companies

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Deputy Assistant US Attorney General Outlines New Approaches for Enforcement of FDA-Regulated Companies

Food and Drug Law Institute LogoOn Thursday, December 7, Deputy Assistant Attorney General Ethan P. Davis, US Department of Justice, Consumer Protection Branch, gave a speech at the Food and Drug Law Institute Enforcement Litigation and Compliance Conference in Washington, DC. In this speech, Deputy Assistant Attorney General Davis outlined what may be the first tangible, specific public policy guidance on enforcement that FDA regulated industry has received from the new administration.

In the speech, Deputy Assistant Attorney General Davis stated that the Consumer Protection Branch is responsible for DOJ’s efforts to “enforce statutes designed to protect the health, safety and economic security of American consumers” and that the FDA is one of the Consumer Protection Branch’s key partners.   Deputy Assistant Attorney General Davis even provided a personal reflection regarding the importance of safe food, drugs and devices to all Americans, by offering that his family, with a nine-year-old son, is concerned with giving their son “only the best and safest foods and medicines” but also reflected that, as “[he has] quickly found out, [he] can’t protect [his son] from everything.”

The cornerstone policy positions were outlined under a section heading in the transcript entitled “The Rule of Law.”    This is where the key elements of the Department’s policy are revealed, and reveal a number of key themes:

  1. DOJ is ensuring that industry “has the room to continue to innovate”, and
  2. That “the rule of law” is a critical part of DOJ’s approach to “accomplishing [that] mission.”

The Deputy Assistant Attorney General then expands on this principle of the Rule of Law phase and states, that the “rule of law” is based on the principle that the United States is governed by law “and not by the arbitrary decisions of government officials” and that the rule of law is about “consistency and predictability”.

Immediately following, and in what appears to this author to be a principle quite in conflict with the foregoing goals, the Deputy Assistant Attorney General then outlines DOJ’s efforts to “roll back unnecessary regulations” and to end the practice of DOJ creating “binding obligations” through the issuance of guidance documents.   In other words, DOJ believes that simple notice and comment rulemaking is sufficient (and apparently preferable) to Agencies (in this case DOJ) providing formal guidance to regulated parties.  How this increases “consistency and predictability” in the rule of law is not clear – to me anyway.

The next main topic covered by the Deputy Assistant Attorney General is the topic of enforcement discretion.  Citing language from Attorney General Robert Jackson from 75 years ago that “no prosecutor can even investigate all of the cases in which he receives complaints,” the Deputy Assistant Attorney General re-affirmed Attorney General Jackson’s philosophy, and affirmed it as DOJ’s current philosophy, i.e., that it will “select the cases … in which the offense is the most flagrant, the public harm the greatest, and the proof the most certain.”

Continuing on, and weaving in his prior statements concerning the policy of regulatory roll-backs, the Deputy Assistant Attorney General posited that because there are “thousands of criminal offenses and thousands more laws that can form the basis of civil liability” and by also looking at the “hundreds of thousands of federal regulations – many inaccessible or incomprehensible” then how do people in the private sector possibly know what conduct will trigger a government investigation?   The Deputy Assistant Attorney General goes further and states that:

the existence of so many laws located in so many places can undermine confidence in the rule of law as evenhanded, accessible, and just. And when you all cannot predict what conduct will end up triggering an investigation by the Justice Department, our enforcement efforts operate to chill innovation.

So where does this clear policy approach leave the Deputy Assistant Attorney General and the Department’s approach to investigations and pursuit of bad actors?  He continues with how these cases will be approached:

[W]hen a new investigation or a potential indictment crosses my desk, I ask myself, and my team, a few questions: Is this a case where people got hurt, or where there was a clear threat of harm? Is this a case where people got defrauded? Is this a case where the target of the investigation acted knowingly or recklessly? If the answer to those questions is “yes,” we will pursue the matter vigorously in the name of protecting the health, safety, and economic security of the American consumer.

The Deputy Assistant Attorney General closes this part of the speech with the following:

The point of this exercise is to weed out technical regulatory violations in order to focus our enforcement resources on practices that threaten consumer health or safety.

*  *  *

Using the Department of Justice’s resources to pursue one-off technical regulatory violations where no one was hurt or defrauded, and where there was no clear risk of consumer harm, does not promote consumer health, safety, or economic security. It only forces companies to over-emphasize technical compliance issues — often involving rules that take a lot of effort to interpret — instead of focusing their resources on developing new, lifesaving medicines and devices.

The third part of the speech outlined enforcement action priorities for DOJ and Consumer Protection Board and includes opioids, dietary supplements and compounding pharmacies.  Characterizing these industry participants as largely “law abiding” companies, DOJ / CPB will focus – especially in the case of dietary supplements – on the “bad apples” of the industry – whoever they are.

During the fourth and final part of the speech,, the Deputy Assistant Attorney General addressed what is known as The Park Doctrine.[1]   This doctrine has been a backbone of Food and Drug Law and enforcement approaches since the earlier United States v. Dotterweich, 320 U.S. 277 (1943).   Now however, the Department of Justice will no longer consider violations of the law alone a sufficient basis for prosecutions.  As the Deputy Assistant Attorney General states:

[I]n evaluating Park prosecutions, we consider whether the unlawful conduct implicates public safety or has resulted in physical harm to individuals. We also look for actual knowledge or willful blindness as to the unlawful conduct on the part of each individual we are considering charging. And we generally avoid getting involved in good faith scientific disputes, because we do not want to stifle scientific exploration and debate, nor do we wish to put those researching creative or innovative means of medical care in fear of criminal liability.

These policy statements are a significant change in direction and approach from prior Administrations, Democratic or Republican, towards the protection of consumers by the Department of Justice.   Overall, bad actors will have more license to act because of greater deference towards what may constitute “egregious” conduct or “physical harm” to individuals.  Whether there will be practical implications to these changes is of course, unknown, and will have to be viewed through the lens of history – not through the distortion of a crystal ball.

[1]  UNITED STATES v. PARK, 421 U.S. 658 (1975), standing for the proposition that “responsible individuals” may be held personally liable for acts in violation of the Federal Food Drug and Cosmetic Act regardless of their individual knowledge of or participation in the violative conduct.

Download the transcript of the Deputy Assistant Attorney General’s speech here

Smile, You’re On FDA-Camera!

FDA InvestigatorThe following entry is an excerpt from a LinkedIn post that I responded to today. It pertains to FDA’s authority to take photographs during inspections, in light of FDA’s new, final “Guidance for Industry on Circumstances That Constitute Delaying Denying Limiting or Refusing a Drug Inspection“, dated October 2014. The subject of the LinkedIn post was: “Lawyers question legality of photography statements in new FDA Guidance on denying, delaying Inspections. “ The post can be found in LinkedIn’s FDA Inspections Group discussion thread.

The discussions focused on what to do or what to consider when an FDA investigator attempts to take a photograph. A number of comments mentioned having appropriate procedures in place to direct inspection conduct. A few comments in the thread addressed the FDA’s authority to take pictures during inspections. My comments to the thread are as follows:

[su_quote]Tread carefully here. Although it is certainly important and strongly advised to have procedures for inspection management, the thought that you can possibly procedurally “restrict” an FDA’ investigator’s lawful activity through procedural development is dangerous at best. Imagine for a minute that you had a procedure that stated that, e.g., “no third party may view manufacturing operations other than during a period from 11 AM to 1 PM”, or, that “no-one except fully-trained, full-time employees of Company are permitted in the manufacturing areas.” Clearly these are in conflict with FDA’s statutory authority, and reliance on these for non-access would be, well, not very smart. The question here is: do the applicable statutes and interpreting case law, along with notice and comment rule-making, along with this Guidance, provide FDA with the authority to take pictures during inspections? FDA clearly thinks it does. Current caselaw is based on situations outside of the FFDCA. I heard a recent statement at the FDAnews Inspections Summit by the FDA that they are itching for a fight on this, and would welcome a legal challenge — which would actually solidify their authority and probably make the practice much more prevalent.

My personal opinion and recommendation on this is the following:

  • Choose your battles with an Investigator — is this picture they want going to reveal State secrets? Honestly, there’s often not much exciting in manufacturing pictures that are of much use to anyone competitively, IMO.
  • Ask the investigator WHY they want the picture — what point — deficiency — are they trying to document? What system or practice are they concerned about. Where does this fit in their overall set of concerns. Ask them if there is another way you can help them with their objective WITHOUT taking a picture. Understand their needs, that a picture may be worth a 1,000 words, and perhaps this is not a big deal.
  • Look at the subject of the picture objectively and understand the underlying issue and the context of the inspection “atmosphere” to that point. Are they “gunning” for a significant enforcement action, or is this really just to help the Investigator do their job. Don’t make a big issue about something that isn’t a big issue.
  • Allow them to take the picture (since they likely have the authority to do so IMO) and make sure you take an exact copy of the picture (request they provide you with a copy) with your own camera for later assessment and analysis of significance.
  • Finally, make sure you have reviewed this information with counsel BEFORE an inspection occurs and understand their best recommendations as to what to do in the event of an issue. This is not 100% settled law (otherwise we wouldn’t be discussing it), so your counsel’s advice is critically important.

Good luck, and be careful out there… [/su_quote]

For assistance with this andother challenging aspects of FDA inspections management, please contact Jack Garvey at john.garvey@compliancearchitects.com or at 888-REG-XPRT.

Welcome To The Party Compounders!

Pharma EquipmentThe September 12 edition of the industry newsletter QMN Weekly contained an article about objections voiced by the International Academy of Compounding Pharmacists (IACP) concerning FDA’s July 2014 Interim Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act. As described in the newsletter, the compounding pharmacies, through IACP, are objecting to the new guidance based on certain portions of the guidance being “subjective” and “unclear”. The newsletter goes on to provide an example from the IACP of this subjectivity and lack of clarity on HEPA filters and guidance restrictions on HEPA filters that are “damaged, dirty or discolored”.

As I read this article, the first thing that popped into my head was:

balloons “Welcome to the Party Compounders!!”balloons

 

To someone who has been in the business of FDA-regulated product manufacturing for almost their entire career, it’s funny to see IACP complain about issues of subjectivity and lack of clarity with this “new” guidance.   First of all, I’ll take a guidance that says “replace HEPA filters that are damaged, dirty or discolored” any day of the week!   If THAT is their example of subjectivity and lack of clarity, good luck with things in the future – it only gets worse. Second, take a look at the guidance: Click Here.   Not only is this document not wholly subjective and lacking clarity – at least relative to current 21 CFR 211 and other FDA Guidance (e.g., the 2013 Guidance on Good Manufacturing Practices for Cosmetic Products), it is quite specific with respect to a number of considerations such as particulates, environmental monitoring program requirements and release testing.   Also though, there is a lot of information and guidance available on the topic of how FDA expects pharmaceutical manufacturers – now YOU compounders – to act and manage your operations.   It’s been close to 36 years since the 1978 GMPs were first introduced and there are many information resources, readily available, describing and detailing how FDA interprets and enforces manufacturing regulations and expectations. This information is easily extrapolated to the practice of “compounding.”

Quality and compliance practice within FDA-regulated industry is not just about finding answers in a book or on the Internet though.   You – the regulated company – have a lot of work to do.   And with that, it might be a good time to provide an important piece of information – a lesson as it were – to the IACP and the entire compounding industry:

In short —
it is NOT FDA’s job to tell you what you
should and shouldn’t do to “comply” with your specific manufacturing operations. 
It is YOUR job to:

  • fully and completely understand FDA’s Good Manufacturing Practice requirements and expectations, and
  • APPLY those requirements to your VERY SPECIFIC product formulation, delivery form and product risk profile based on therapeutic indication.   If you can’t or are unwilling to do this – you should not be manufacturing products for introduction into interstate commerce. And if you ARE willing, but don’t have the knowledge or experience, there are plenty of good consultants that would be more than willing to help you with understanding your role, responsibilities and obligations for meeting all of FDA’s requirements and expectations.

Since Drug GMPs Final Rule Image1978, pharmaceutical manufacturers have dealt with the skeleton structure of 21 CFR 211, the pharmaceutical GMPs, and the massive amounts of guidance and interpretation overlaid onto the regulatory structure by individual FDA investigators during enforcement actions.   Although the structures of this long-standing regulation and guidance, and the corresponding enforcement activities that flow from them, can be maddeningly challenging and complex, it has generally served the public health well for these 36 years.   The IACP and the compounding industry – if they want to restore any shred of credibility after the recent tragedies resulting from product quality failures – need to get on board with the FDA and the rest of the pharmaceutical industry and begin investing, learning and executing on improved quality management systems that are just beginning with this new, interim guidance.

Welcome to the Party!

CAPA – The Untold Story

Try as I might in my consulting work, I can never seem to get away from CAPA.    As much as I would like to help companies prospectively improve their process control;   embrace better quality system integration and document design;   assess and implement computer-based quality systems; and use process risk analysis to rationalize quality system decisions and improve inspection outcomes (among other things I love to do), it always seems like companies need help – and lots of it – with CAPA.

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 understanddocument 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.

CAPA System Integration

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.  (2018 Update:  See Writing for Compliance®)

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:

STORY STRUCTURE1 CAPA STRUCTURE
Exposition:    Character /
Scene Development		 Background and Details of Event/Incident
Conflict / Rising Action Investigation
Crisis / Climax Root Cause Analysis
Falling Action / Resolution Corrective / Preventive Action

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.  (2018 Update:  See Writing for Compliance®)

—————————–

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)

UPDATE: Free FDA GMP / QSR Ebooks for IPhone, IPad

This is an UPDATE to a post from May 2010.
Please click this link for the original post.

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!

[su_box title=”UPDATE: PLEASE SEE OUR NEW RESOURCES PAGE” box_color=”#E35205″ title_color=”#fffcf2″]Please see our new RESOURCES page to download the most recent regulation eBooks for the iPad, iPhone and Android smartphone devices.[/su_box]

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!

Ensuring Supply Continuity for Medically Necessary Drug Products

THE FOLLOWING POST IS FROM FDANEWS.  For additional information, please see:

Ensuring Supply Continuity for Medically Necessary Drug Products

The ink is barely dry on the draft MNP guidance, and the pressure is already on many drug and biologics manufacturers to develop emergency plans to meet FDA requirements. Here’s how to get up to speed — fast.

Ensuring Supply Continuity for Medically Necessary Drug Products

Your Game Plan for Compliance and Supply Chain Assurance

An FDAnews Webinar

Tuesday, April 20, 2010 · 1:30 p.m. – 3:00 p.m. EDT

Register Today

In January 2010, the FDA released a draft guidance that requires manufacturers of medically necessary drug products (MNPs) to have specific emergency plans — and corresponding SOPs — for each of their facilities in case of supply chain disasters or high absenteeism.

The guidance says emergency plans should be developed, written, reviewed and approved within a site’s change control quality system under the requirements of 21 CFR 211.100 and 211.160. In addition, a broader plan should address the potential for shifting operations, resources or personnel across multiple sites.

What exactly is a medically necessary product? The FDA calls a product medically necessary if it falls into one of four categories:

  1. Where the company is the sole source of the drug or the drug supports a  significant share of the U.S. market
  2. Antiviral drugs that may be needed during a pandemic
  3. Drug products for conditions such as diabetes, high blood pressure, congestive  heart failure, asthma and cancer
  4. Products that are especially vulnerable to shortage because of typically low inventory levels in the supply chain

Because the guidance provides only a general outline and simple overview of the steps required to implement the plans, manufacturers are left with the difficult responsibility of adapting the guidance for their facilities without any details of how to go about doing it.

Fortunately, help is at hand.

Mark your calendar now for this 90-minute webinar on Tuesday, April 20. It’s all you need to get up to speed on the FDA guidance, “Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products.”

Your guide through the draft guidance is Jack Garvey, a leading lawyer and consultant on FDA compliance matters. In 90 information-packed minutes, he’ll spell out precisely how you can adapt its provisions to fit your facilities. Here’s just a taste of what he will cover:

  • The definition of medically necessary product (MNP)
  • The FDA’s Drug Shortage Program — what it is, what are its implications
  • The 7 main elements of the MNP draft guidance
  • Which elements are “requirements-oriented” and which are “goal-oriented”
  • What the FDA notice provisions are
  • How and where to direct notice to the FDA in event of a plan activation
  • Resolving conflicts between guidance provisions and business continuity planning
  • Developing a plan: Suggested elements and components
  • Testing the plan for effectiveness: What the FDA expects
  • And much more

This is a workshop you attend without leaving your workplace. Simply make sure you’re in front of a screen at the appointed time. Have questions? Submit them via email for answers by the time the session ends.

Everyone in your organization with a role in medically necessary drug products deserves to take part in this event — and they can do so, at a cost that won’t break the budget. You pay a single low registration fee per facility, regardless of how many participate.

Don’t let this latest FDA draft guidance trip you up. Turn to an expert to learn what you — and your staff — need to know. Sign up today.

Register Now

Who Will Benefit

  • Operations
  • Manufacturing
  • QA/QC staff
  • Compliance officers
  • Supply Quality/Supply Chain managers
  • Regulatory/legislative affairs professionals

Register Now

Meet Your Instructor
John C. “Jack” Garvey is the founder of Compliance Architects. A leading FDA regulatory, compliance and operations executive with more than 25 years of experience developing and leading quality, regulatory and compliance initiatives, Mr. Garvey focuses on compliance and quality strategy development and deployment for leading life-science companies. A dual background in law and engineering gives his clients an advantage in resolving complex regulatory, quality and compliance issues.

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You’ll have access to one log-in and dial-in for the live 90-minute webinar for unlimited participants. You also receive all presentation materials and the opportunity to ask question by phone and email, plus an audio CD and transcript for the entire session.Webinar Only: $327
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