Compliance Zen

July SmarterCompliance Newsletter Available

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

• Qualifying virtual consultants and contractors as suppliers under FDA rules
• Four ways to use Quality by Design to improve your regulatory submission approval rate
• FDA enforcement review of warning letters on training-related issues
• Dealing with under-reporting at clinical sites
• Quick tips to improve your presentations
• and more....

Subscriber downloads include:

• Extended article on qualifying virtual consultants and contractors
• Health Canada's new GMP regulations
• Seven recommendations on complying with FDA's new draft guidance on postmarket studies and clinical trials

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 issue free so you can decide if you want the trial or want to jump right in and start getting smarter about 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 

Keep an Eye on Costs with These Easy Steps

Costs ignored are costs out of control.  Four steps to ensure control:

1.  Monthly check-ins.  Once a month, review your operational expenses.  This is not about the details, but rather large monthly “buckets” – telecom bills, transportation costs, total office supplies, and so forth.  Do your people see laptops and crackberries as perks, or do they really monitor operations in real-time 24x7 and travel consistently?

2.  Flag trends.  Look at the monthly expense for a particular category, such as phone bills, and over a 3-month to 2-year period, look for trends.   Are costs going up or down by more than 10-15%?  Why?

3.  Identify disparities before you dig.  If you are growing, your costs should be as well.  However, if you’ve grown by 5% and your costs have grown by 20%, then it’s time to look at the details of why.

4.  Heads-up notices.  Ensure your purchasing policies have an appropriate threshold ($5,000, $50,000, etc.) wherein a simple cover memo or email to you must be sent as a “heads-up” (not pre-approval) that explains where the money is going to go and what the rationale is behind it.  To keep this from being micro-managing, set it up so if you don't repond "WAIT" within 24 business hours, you're assumed to have no problems with the purchase.  This "heads-up" email or memo is just an opportunity for you to bring any additional information you might have (but haven't yet shared) to the table before the money is spent (for instance, one of your teams wants to bring in a temporary worker for a month to help with a work backlog but doesn’t realize you’re in the process of hiring a new staff member who’s first task will be to tackle that backlog).

 

For more ideas and tactics, download my e-booklet, Ten Ways to Control Compliance Costs, or see my article “Cost-Effective IT Outsourcing.”

Featured Reading: Sun Tzu for Execution

Steven Michaelson has followed up his bestseller, Sun Tzu For Success , with this excellent book on leadership skills and competitiveness.

There are five sections of the book, corresponding to the main thrusts of Sun Tzu’s Art of War:  Simplicity, Alignment, People, Flexibility and Strengths.

 In his Simplicity section, Michaelson points out:

·         complexity is expensive

·         people understand and execute simple ideas

·         celebrate and reinforce behavior you want to see (read my Regulatory Affairs Focus article, “Positive Enforcement,” for a strategy that draws on this for compliance).

 The Flexibility section includes recommendations on:

·         dealing with employee turn-over

·         drawing the line on process details

·         decision-making guidelines.

The other three sections have similar short, easily adopted techniques, suggestions and case studies.

The final section, Towering Strengths, is the weakest if only because so much business literature today covers the concepts of market differentiation ad nauseum.

While you may not want to share Sun Tzu For Execution with your staff, you’ll definitely want it in your executive library. 

Cerulean News Brief: July 2009

John Avellanet Chairs FDA Supplier Quality Management Congress
Cerulean’s Managing Director, John Avellanet, has been named chair of the upcoming Supplier Quality Management Congress this August 19-21 in Arlington, Virginia.
Learn more …

 

---

 

Teleconference:  Verifying Data Integrity in Regulatory Submissions
On July 16^th, ExpertBriefings offers a teleconference by John Avellanet reprising his May talk on steps to verify the record integrity of your regulatory submissions, including many of the questions and analyses FDA reviewers use.  A recorded version is available on the Cerulean website (http://www.ceruleanllc.com/seminars/) if you cannot attend the live event.

Learn more:  http://www.ExpertBriefings.com

 

Teleconference:  How to Use a Quality Systems Management Review to Prove Compliance
On July 21^st, FOI Services hosts John Avellanet reviewing a twelve step methodology for systematically preparing for a quality systems management review, incorporating risk-based decision-making that actively engages top executives, and the records you need to retain to prove regulatory compliance to the FDA, EMEA and Health Canada.

Learn more:  http://www.FOIservices.com/tc/moreinfo/jul2109.html

 

July Issue of SmarterCompliance^™ Newsletter
This month’s issue of Cerulean’s newsletter is set to be published the week of July 27th.  Topics include:  how to qualify virtual suppliers (using a virtual consultant as an example); a question on reviewing data integrity in regulatory submissions; advice on Quality by Design, record integrity, and regulatory submissions; and more.
Subscribe...

 

New Regulatory Document Of Interest:

 

·         Health Canada Updated GMPs for 2009

 

Four Ways to Better Communicate Behind-the-Scenes Decisions

All the cultural transparency and emotional leadership advice aside, there are times when managers need to make decisions behind closed doors.  To minimize negative reaction, follow these four tips:

1.  Plan the announcement.  As you draft the announcement, put yourself in your employees’ shoes.  Write with an eye toward how personnel will respond.  Just stating the facts will not be enough.  Rather, compare the decision to other decisions in similar contexts (either in or out of your company).

2.  Provide actionable next steps.  Give your teams something to act upon—action will minimize the inevitable rumor mill, allowing teams to focus on implementation not speculation.

3.  Monitor and respond.  The goal is not to justify yourself or your decision.  Instead, try to eliminate misunderstandings and distortions of the facts and the context.  “Message sent” does not necessarily mean “message received.”  Give people time to digest the decision before responding  to misrepresentations; some degree of distortion is inevitable in any level of person to person communication.

4.  Be patient.  Give your folks time to act appropriately before you step in with further guidance.

 

For more leadership quick tips, consider subscribing to SmarterCompliance newsletter.  Every month I craft a section on tactics you can put to immediate use.