November 17 - Titusville, NJ - Regulatory Update

Our last stop on the LLL tour for 2009 was held at the impressive Johnson & Johnson facility in Titusville, NJ.

We changed it up quite a bit for this final 2009 event. We had a lot of veteran clients in the audience and chose to use our time together to discuss hot challenges as well as update the audience on the new ComplianceWire® release. 

We spent a while addressing the new regulatory direction under Dr. Margaret Hamburg who joined FDA in May, 2009 and swiftly outlined six initial steps to hone the effectiveness and timeliness of the agency’s regulatory and enforcement system:

• Post-inspection follow up
• Warning letters
• Work with regulatory partners
• Enforcement follow up
• Swift actions
• Close-out letters

Drilling down into some of these topics:  With regard to 483 response timeliness, once FDA provides inspection findings, companies will have 15 days (used to be 30) to respond.  More important, any corrective action detailed after 15 days will not be considered in preparation of warning letter. 

Moving to warning letters, FDA’s Chief Counsel will no longer be required to sign off, which will likely result in more warning letters being issued at the district level.  Finally, a new (and hopefully motivating) part of the process for many will be a close-out letter that will follow a re-inspection and provide assurance to the company that they have ameliorated all issues behind the specific warning letter.

FDA has hired more investigators and is focused specifically on:

• Consent Decrees – signed within 4 wks of inspection
• Product Seizures – swiftly if product safety concerns arise
• Regulatory Cooperation – ICH and GHRT guidance
• Faster FDA Response – Enforcement actions may be initiated after only a single inspection
• Clinical – Focus on data
• Imported Sampling – Concern over contaminated imported APIs et al
• Adverse Events – Focus on weak AE reporting

From FDA we moved to OIG and DOJ, who had just spoken at the Pharma and Device Congress.  Both agencies stated that in the coming year, companies should expect scrutiny to be very high.  In fact, it will, “not only continue, but will escalate.”  An in-depth analysis of the record Pfizer fine of $2.3 B for off-label promotion and the specific actions required in the Corporate Integrity Agreement were outlined.  Finally, DOJ provided a list of hot pursuits: FCPA (SEC chimed in as well), all anti-kickback activities, off-label promotion, and Medicare/Medicaid fraud.

November 4 – Seattle, WA – Life Science Compliance

Our most recent stop on the LLL tour was in Seattle, Washington.  Demi Allen, VP of Law & Compliance and Chief Compliance Officer for ZymoGenetics gave the group a history lesson on compliance for life science companies--starting with the 1991 Federal Sentencing Guidelines and working its way through Enron, Sarbanes Oxley, and OIG oversight--to today’s hot issues of off-label marketing and sales rep relationships with physicians.  Founded in 1981, ZymoGenetics is a 350 person biopharmaceutical company with one major product on the market and a development pipeline of proteins, antibodies, and antibody-like molecules.

Demi spoke of the major elements of a compliance program and how he has implemented that program at Zymo such that it is accessible and relevant to all employees.  Senior level involvement, training and communication are key to achieving the company’s core principles of ethics, focus, teamwork, adventure and citizenship.  The program focuses on decisions that consider the impacts on the company’s stakeholders, including patients, healthcare providers, employees, shareholders, business partners, and the community.

The next part of the discussion outlined the relationship between Zymo and Kaplan EduNeering, which began three years ago for clinical training.  Next, Zymo rolled out ComplianceWire for GxP training and began taking full advantage of the LMS capabilities.  Usage has since expanded to corporate, sales & marketing, and healthcare compliance, including a custom Code of Conduct course for all employees.  The partnership will continue as Zymo releases new products over the coming months and years. 

October 6 – San Jose, CA – Role Based Training

As we discuss during our LLL tour, oftentimes it is our clients that give us the best ideas for CW enhancements.  Such is the case with Role Based Training, which was spurred initially be the needs of the Stryker Corporation.  So last week, Kerri Ann Beherndt from Stryker Endoscopy in San Jose, CA shared her CW journey, which began in February, 2006.  Key challenges for Stryker were: how to develop consistency of training requirements across the organization; how to define minimum training requirements; and how to create a structure in CW to support the company’s role-based training criteria.

Most of you are familiar with the red/yellow/green reports such as the one below. 

Click Graphic Above for Larger Image

Development and use of this report is one of the “best practices” detailed by Kerri Ann.  Others are:

• Automating role based training by assigning a role as an attribute to a user;
• Integrating on-the-job training using Forms into the program;
• Separating external training, such as Oracle by making it a separate curricula;
• Setting up automated reports for each manager (make sure you send a duplicate to yourself);
• Adding “reasons for assignment” to explain to managers each time you set up a training item;
• Encouraging users to drill down to the training they need to complete today;
• Supervisors using the system to plan the production schedule for the day and can easily determine which workers need cross training.

Going forward, Kerri Ann will be involved in a document management system integration; increased use of Forms for OJT (and is excited about SmartForms, coming out in the December release); and is adding a sub-curricula level to the hierarchy to further detail training required for each role. 

According to Kerri Ann, “the productivity of our managers has definitely improved since we started using ComplianceWire.”  But the most important news is that Stryker Endo has not had any training audit findings since bringing on CW.

October 6 – San Jose, CA – Trends in Training Content

What is a CBT in today’s informal training world?  How can you contextualize mastery learning?  When should you integrate “crowdsourcing” into your program?  These and other questions were raised during a presentation hosted by Kent Malmros, Kaplan EduNeering’s Director of Business Development. 

Learning organizations are grappling with ways to integrate new technology into their learning programs, without forfeiting the tenets of good instructional design, testing and evaluation, or training relevancy.  As technology has advanced, the use of audio, video, 3D, gaming, blogging, Twittering and others are now finding their way into learning programs, providing tangible benefits.  Kent outlined a few of the ways that Kaplan is advancing this approach.  For example, we will soon be releasing several series of short (10 minutes or less) videos using techniques garnered from the newsroom. 

We have worked with subject matter experts in areas ranging from ethics and sustainability to audit readiness to prepare modules that can be rolled out weekly or monthly based on need.  This “just in time” training can address a hot topic in a timely fashion, without a huge training or budgetary investment.  Another approach is the creation of a virtual workspace for learning and collaboration that we are introducing to clients via one of our media partners.  This approach combines synchronous and asynchronous learning using 3D Immersive Simulations Tools to replicate any type of training in one environment.

Kent closed with some suggestions for addressing the training challenges of the new workforce:

• More CHANNELS, with retained metrics
• Organization of content is as important as CREATION of content
• Multiple TOUCH points become critical
• Embrace the COLLECTIVE

September 9 - Chicago, IL - What keeps you up at night?

One of the first topics we raise during the LLL sessions is to go around the room and share business challenges.  Common ones that emerge are: difficulty in onboarding new employees and contractors; assuring that personnel are trained and competent to perform their jobs; training has become too expensive and doesn’t deliver the “just in time” results needed; and a lack of conformance to policies and procedures.  During our September 9 event at Abbott, several new challenges were brought up that I thought we should share and add to our next session:

• Centralization of training to include professional continuing education updates and other internal and external programs that should add to an individual’s training repository.
• Rolling out training to staff without computers, such as those on the manufacturing floor.  Special concern over contractors or part timers that are paid hourly.
• How to keep your program alive.  Concern that management needs to understand that they need to commit ongoing resources to ensure the goals for purchasing an LMS are achieved after the initial implementation.
• The stigma associated with the words “compliance training.”  This was a great topic, with discussion ranging from rebranding the training initiative and ComplianceWire site for your company to tying the training to “impact on business” versus return on investment.

September 9 - Chicago, IL - Building a Role-based Qualification Curriculum

Dave Peterson, Kaplan EduNeering’s Director of GMP & Quality Systems and a 30-year veteran of quality management, delivered a session on this important topic.  Dave discussed how to establish the value of role-based curricula, he shared FDA and investigator expectations, identified some industry best practices, and presented a compliance model for role-based qualifications.   We encourage you to review Dave’s presentation, in which he outlined a process for assuring that each employee has the education, training, and experience to perform their job (as in 21 CFR211.25 and a common question in FDA audits). 

We looked at laboratory workers and identified the audience as including chemists, analysts and microbiologists.  We selected chemists and chose liquid chromatography as the specific job requirement to target.  In writing job requirements, we selected “performing the same analysis 6x with repeatable results within a standard deviation of 3%”.  Next we gathered the appropriate methodologies and SOPs for assuring those results.  We then moved on to identifying and filling any gaps, such as adding a skill test for the chemists.  In finalizing the learning program, we talked about gaining buy-in from the chemists that are doing the work each day.  Not only will the program be adopted more successfully, but the chemists will provide the most valued suggestions for improvement.  Finally, we load the content into the LMS and disseminate to individuals with that same job responsibility across the organization.  A best practice emerging from this process is to link this role-based qualification process directly to the job description.

July 15 - Princeton, NJ - Metrics & Reporting - Communicating to Executive Management

There’s a reason for old adages—they work!  So I’m going to use the one that says, “You can’t manage what you can’t measure,” to describe this section of the LLL program. 

Management is looking for quick status of information that is available ‘on demand’ to immediately gauge the level of compliance within their organization in order to determine shat is working or, more importantly, what is not working.  Reports have to be clear, concise, reliable, timely and actionable.  Thus, the invention of the compliance dashboard.  The following is an example of one that our clients use that achieves all five goals.  Take a look so that we can talk about it during the next stop on the road trip.