Compliance Zen

September SmarterCompliance Newsletter Available

The September issue of my SmarterCompliance newsletter is now available.  Topics include:

• An interview with a former FDA prosecutor on mistakes executives continue to make with quality systems documents and business emails
• Steps to keep your clinical data in line with FDA expectations on data integrity
• What FDA expects when it comes to your sampling plans
• How to improve your leadership abilities in just 30 minutes a day
• Tips on dealing with different FDA inspector personalities
• and more....

Subscriber downloads include:

• Extended interview with the FDA former prosecutor on how to avoid document and email mistakes
• The Competitive Enterprise Institute's comments on FDA's draft guidance for presenting risk information

You can get my monthly newsletter here:   http://www.ceruleanllc.com/Newsletter/Subscribe.htm

And if you're not sure if you want to subscribe, I do offer free 6-month trial subscriptions with my executive quick-start pack.  Alternatively, if you sign up for my mailing list at Cerulean, I'll be happy to send one or two issues free so you can decide if you want the trial or want to jump right in and start getting smarter about FDA compliance.

Details on the executive quick-start kit are here:  http://www.ceruleanllc.com/Toolkit/QuickStartKit.htm

Join my Cerulean mailing list here:  http://www.ceruleanllc.com/ContactReq.aspx

Bulletproof Yourself against FDA Enforcement

I just updated part of my SmarterCompliance Toolkit, the Bulletproof Yourself against FDA Enforcement, to incorporate all the most recent trend analyses and insights from multiple FDA colleagues, including the top areas FDA intends to target for enforcement in 2010.

Here's the low-down on what I cover in the revised session:

• Learn what hot button items FDA is scrutinizing through 2010

• 5 keys to successfully responding to 483s in 15 days or less

• Understand how to determine if you're attracting agency attention

• Warning letter citation trends

• What FDA inspectors expect when examining your CAPA processes

• Be able to answer the #1 question inspectors will ask about your supplier qualification program

• How to maximize your quality systems efforts and productivity

• Supplier due diligence aspects inspectors look for - and how to make sure you've got it right

• Quickly distinguish between critical compliance needs versus "nice-to-have's"

• Appropriately lower costs, risk and liability

• Put in place practical strategies for each area FDA is scrutinizing

• See the three secrets to passing an audit every time

• Develop an action plan to appropriately prepare for, handle, and follow-up from inspections

If you'd like to attend live, you can do so by just visiting http://www.ceruleanllc.com/webinar.  But registration will close this week.

Otherwise, simply click on the Bulletproof Yourself against FDA Enforcement to go to the page where you can buy the recorded version plus still get all the great reference material, checklists, and other toolkit items.

And, as always, if you've any questions on the material, please feel free to contact me.

Dangerous Documents and FDA Compliance

Continuing my efforts to help folks understand that it is their actual records - not their SOPs - that prove whether they've complied or not to FDA regulations, I've teamed up with three other folks to give a pre-conference workshop on October 12 at AdvaMed 2009.

Entitled Dangerous Documents: Avoiding Land Mines in Your FDA Records and Emails, the executive workshop will review four key areas:

• How to teach employees to create documents that reflect your commitment to quality
• How implement an FDA-compliant records control program of policies, SOPs, and retention schedules
• The types of documents your competitors and prospective partners and customers can obtain about your firm (such as 483 observations and meeting minutes) through the Freedom of Information Act
• Advice on implementing an electronic document management system (EDMS)

The session runs approximately three hours and it's FREE ... well, free to attendees of AdvaMed2009.  All you need to do is email mac@advamed2009 no later than October 1 and let him know you plan to attend the workshop.

So, if you're planning to attend AdvaMed 2009, consider joining our workshop.  And like every compliance speaking talk I give, it'll be full of real-world tips, lots of stories and practical advice, plus loads of reference material you use to quickly implement all the learning points.

I hope to see you there!

Defensible Documents to Prove FDA Compliance

I'm going to be giving a teleconference for FOI Services on September 23rd entitled Creating Simple, Defensible Documentation to Prove FDA Compliance.  In conjunction with Nancy Singer, a former FDA and Department of Justice prosecutor, we are going to lay out how to create simple, yet comprehensive SOPs and documentation to prove compliance and "good faith" intent.

A copy of my SmarterCompliance^tm SOP template plus an example SOP using the template will be provided.  Attendees will also see a sample matrix designed to help you define what regulations and international harmonization guidelines apply to you, the documents you need to have in order to prove compliance with these regulations, and how to identify which processes, SOPs and policies of yours produce these documents.  Those of you familiar with my records retention schedule for FDA compliance can then just add these columns and voila ... your documentation controls and your ability quickly show any inspector your proof is complete!

Here are the various items we're going to cover:

• Six activities that are part and parcel of complying with regulations
• Do's and dont's for using off-the-shelf templates
• How to determine if a consultant's interpretation of the requirements is accurate
• Ways to get buy-in for your approach
• Tips for establishing various levels of documentation
• How to develop a matrix to cross-reference regulations, documents and SOPs
• Simple set of metrics to gauge your SOPs, trend, and provide continuous improvement

Everything is from my own personal experiences - and I know that Nancy talks about mistakes companies have made in their "attempts" to properly document activities and decisions to FDA inspector expectations.

If you'd like to attend, you can register through FOI Services at:  http://www.FOIservices.com

FDA Calls for Holistic Compliance

On two separate occasions last month, two separate FDA officials - Commissioner Dr. Margaret Hamburg and CDRH's resident expert, Kimberly Trautman - stated simply that just having a quality system was note enough.  Companies need to build a systemic compliance program from preclinical through post-market surveillance.

Commissioner Hamburg called upon biopharmaceutical and device executives to demonstrate "a commitment to compliance backed by a strong compliance program.  Now is a good time to reassess whether you have such an effort in place" (August 6).

And then, at the Supplier Quality Congress, Kim Trautman told executives, "You must have an integrated compliance system - you cannot just rely on Quality.  Everyone must be involved" (August 20).

Both of these statements echo the philosophies in the ICH and the GHTF harmonization efforts.

In my own experiences, some of which you can read about in my free booklet, Ten Ways to Control Compliance Costs, I have found that this type of holistic, systemic approach to compliance can reduce the time, effort, and costs necessary by at least 2% of your entire company's revenue.  And that's just one way that Regulatory Affairs and Quality personnel can directly contribute to a company's bottom line.

Without such a holistic strategy, your costs and risks will continue to multiply.

Practically speaking, you need to develop a long-term strategy to put in place this type of holistic compliance framework.  Don't expect this to happen overnight.  Elements including tying together Regulatory Affairs, Quality Management Systems, Records and Document Management, Data Integrity, and Corporate Compliance.

I review how to establish a cross-functional team to put a strategy in place that fits your company in my newly revised Bulletproof Yourself against FDA Enforcement (in 2010) webinar and recorded seminar.  I try to revise this on a yearly basis to constantly incorporate new analyses, trends, and FDA expectations.

Your corrective and preventative action (CAPA) systems and supplier controls underlie all aspects of compliance; your records retention and management provide proof of your "good faith" and compliance; and your quality management reviews demonstrate executive involvement and proactivity.

Just as FDA inspectors start by examining your CAPA and supplier controls, so too should you use these as your base areas to tie together all aspects of regulatory compliance and quality systems.

In the 21st century, this type of holistic compliance "loop" is how you can best balance bottom line realities with compliance necessities.

Join Me at the Joint PDA / FDA Conference

I'll be at the joint PDA / FDA regulatory conference in Washington, D.C. next week.  Thankfully, I'll just be a little old attendee; no speaking or workshop running, or anything else where I'm "on."  It's the first conference I've attended and not had to speak, chair, run a workshop, etc., since June 2008, and I'm really, really looking forward to it.

I won't just be listening to others speak, though.  I'll be conducting some interviews for my forthcoming book on personalized medicine and how to adjust your regulatory compliance and quality management systems.  If you'd like to give your thoughts, experiences, or worries on the FDA compliance challenges facing us as we move forward in the 21st century, please give me a shout.  I'm more than happy to hear from you and schedule an interview.

Otherwise, if you're going to be at the conference, I hope to see you soon!

And if you want to hear or see me speak, here are some of my upcoming engagements:

Sept. 23rd - teleconference on "Defensible FDA Documents"

Sept. 25th - speech at Contract Pharma Conference in New Jersey

Sept. 29th - webinar on FDA enforcement trends and planning for 2010

Avoiding Groupthink in Compliance – Six Tips

Being compliant isn't just about reading and following the regs.  It's about balancing business and regulatory expectations with the needs of the people involved.  Good compliance is about leadership.  And the smart executive can turn good compliance into competitive advantage.  So what's stopping you?

One hurdle might be the need for constant consensus.  It's something we've all fallen prey to at times in our careers.  But eventually, the need for mutual support and approval can lead to doubt suppression, illusory assumption sharing, and premature consensus.

Ultimately, this results in disastrous decisions, especially when dealing with FDA compliance and quality systems.

Six tips can help:

1.  Encourage skepticism.

For any significant decision, ask your colleagues or staff to identify at least two reasonable conditions under which a particular choice your team faces might result in failure.  When I advise Quality Systems and Regulatory Affairs teams on lean compliance, I suggest they use the "2% rule" to define "reasonable."  In other words, for something to be reasonable, there has to be a 2% or greater chance of it working, occurring, etc.  It's a great rule-of-thumb for figuring out where to draw the line when it comes to how much risk assessment is enough.

2.  Allow freewheeling discussions.

Talking in a group under strict rules and protocols can inhibit the greater intelligence of group thinking; informality can encourage the expression of doubts and ideas.

In a regular staff meeting, you might want to stick to the agenda to keep things focused on action items.  However, for reviewing open items and trying to come to conclusions, this is the way.  Even in staff meetings, consider leaving some time at the end of the meeting to raise open issues.  15 minutes can more than suffice to simply raise the issue and get input.  Save the decision-making for later.

3.  Foster a “third way.”

Keep an eye on group dynamics—when polarization threatens, push the two “right” and “wrong” decisions off the table and force your team to identify at least three unorthodox options that might work.

This can be a painful moment for many quality and regulatory professionals who have that "black and white" mentality.  You may be surprised at how little they will contribute ... until they see that the unorthodox options actually work.

4.  Restate conclusions.

It may seem obvious, but this is so often forgotten in the heat of the moment.  Summarize any  discussions along with any “to-do’s” for various individuals.  It’s one thing to agree with something in a meeting; it’s another if you end up tasked with it.

For leaders, this is a good way to closeout any meeting.  Years ago, I worked for a boss whom I'll call Brent.  He and I did not see eye to eye most of the time.  However, he did observe something about my meeting style that, while I didn't like it at the time, I've since realized was extremely accurate and helpful.  I rarely ever ended a meeting by summarizing what each person was supposed to "go do" and get done before the next meeting.  As a result, I spent a lot of time chasing down my staff to clarify deliverables; my staff started to get resentful, thinking they'd left the meeting with 3 things to do only to find out they actually 4 ... or 2.  When I changed that, and ended every meeting with a summary list of all the things each participant was going to go do, productivity and morale went up almost immediately.  Thank you to Brent for this advice.

5.  Sleep on it.

For particularly challenging decisions, break off discussion before consensus and have everyone “sleep on it” for a day.  Pushing against an artificial deadline can create unintended resistance, miss midnight inspirations, or erode trust.

Unless you’re an emergency room physician, you always have the option of delaying for a day.  This includes responding to FDA 483s.  Your response isn't due now - it's due 15 working days from now.  And make sure to get that response done at least a day early so you and your team can sleep on it.

6.  Just say "Why."

This is one that I admit I learned from my wife.  And over the years, it's worked wonderfully in work settings.  Consider laying down a “Just Saying ‘No’ Isn’t Allowed” ground rule.  Anyone voicing their resistance to an idea or choice must state their logic AND provide at least one reasonable alternative.  So if your question is, “Are we ready to submit this NDA?” and someone says No, that person needs to provide their reasoning along with reasonable steps to be taken (including in a reasonable timeframe) to get the NDA ready for submission.

Each of these tips will help you improve your ability to achieve compliance and business flexibility.  That's the role of a good leader and the path to success.

Are you ready?