For the past few years, the U.S. pharmaceutical industry has been dragged across hot coals because of marketing and sales practices. Misbranding or misrepresenting violations continue to erupt, but another risk is rapidly taking over the headlines, dockets and public opinion about the industry. Good Manufacturing Practices (GMP) violations have become the new healthcare fraud as the Department of Justice (DOJ) tests out new legal theories under the False Claims Act (FCA). The FDA has dusted off its regulatory authority to prosecute GMP violations. After blistering reports by government agencies, the FDA has ramped up inspections of domestic and foreign pharmaceutical plants — brand, generic, contract and Active Pharmaceutical Ingredient (API) — both in frequency and depth. And just to cement the growing public and legislative distrust of drug quality and safety, massive recalls have kept quality problems in the headlines and on the minds of millions of patients. 

The common denominator of pharmaceutical product quality and effective compliance is cGMP compliance, yet virtually all quality problems occur at plants with well-established compliance and cGMP training programs. More than one chief executive officer has been blindsided when hit by an FDA Warning Letter or news headline. Why didn’t employees and subcontractors comply with GMPs? How could workers be unqualified even though they received the required training? Why didn’t the training “stick”?

Ten years ago, training was measured in hours; today, it is judged by results. A failure to achieve the required results is often preceded by one of four statements. Those statements, and the thinking that fuels them, point to the source of the problem — and to potential solutions.

1: “We’ve had A Training Program for Years.”

Like compliance, cGMP training is only as good as its flexibility in meeting changing conditions. Some long-established training programs are stuck, not only in aging technology, but also in content and instructional techniques. They may have been cutting-edge once but they don’t work in this world, with these needs, for these workers.

Instructional approaches long since dismissed may infuse materials and courses that are updated and patched, but not upgraded and replaced. Even the hardiest among us have suffered through presentations that involve little more than an individual reading bullet points projected onto a screen. The content lacks context, fails to hold our interest and fails to show the consequences of positive or negative behavior. That scenario is grueling enough for a 40-year-old, but imagine its effect on younger workers accustomed to a high-impact diet of gaming and texting. 

Training works when it is matched — in format, style and tone — to the knowledge needs of a defined audience. Instructional theory and knowledge management practices now employ multiple training techniques including computer-based, online, instructor-led, executive coaching, mentoring and hands-on elements. 

What You Can Do: Analyze your existing program the same way a competitor would, avoiding the temptation to protect old favorites and once-costly infrastructure. Consider an outside consultant who can see the system as a whole, not as a collection of add-ons. Integrate rich graphics, scenarios and role-playing, video or interactivity, even if it is only used at the start and end of each course. Use the FDA’s risk-based approach to identify and prioritize training needs. Address those needs with a systematic plan to target updated learning to the learner’s job function, experience and learning constraints such as limited literacy or industry familiarity. Recognize the essential role of monitoring, documenting and managing the training program. Contextualize everything!

Compliance requires that you respond quickly to knowledge gaps, poor comprehension and inadequate application of new skills. Investigate technologies such as “cloud computing,” which virtually eliminates capital costs for new technology infrastructure, reduces the administrative burden on your organization and provides added protection against the loss of training documents required for compliance. Mobile devices such as iPads or smartphones can integrate training into the social media aspect of your users’ lives. Finally, recognize that training programs require continual improvement, not simply by adding layers but by regularly assessing and improving program effectiveness. 

2: “Our SOP Training Program Leads the Industry.” 

Maybe it does and maybe it doesn’t. In 2010, the most common violations cited by the FDA following cGMP inspections of life science facilities followed a common theme.

1. “Absence of written procedures . . . ”
2. “There are no written procedures for . . .”
3. “Your firm does not have adequate written procedures . . .”
4. “Failure to establish and maintain procedures for . . .”

Standard Operating Procedures (SOPs) form the essential structure of effective compliance, operational efficiency, product quality and business productivity. Despite that, SOP violations are frequent, familiar and indicative of quality risks. 

Common problems:

• SOPs are often incomprehensible or inaccurate, leading employees to ignore them. From the perspective of the employee, if the SOP doesn’t make sense, it doesn’t exist.
• SOPs are inaccessible, not only to inspectors but also to employees. The typical employee in a pharmaceutical manufacturing plant may be responsible for staying current and compliant with more than 100 SOPs at any one time. Easy, rapid access to SOPs for reference is essential. Stacking binders of SOPs in an unused office isn’t the answer.
• There are no written procedures, forcing employees to operate “on the fly,” making up processes and procedures as they go along. Especially risky, downstream processes may be compromised because they rely on data that have not been correctly developed or documented.

What You Can Do: First, ditch the paper. SOPs must be written, distributed, continually updated and constantly accessible (electronically) for employees as well as inspectors and internal auditors. Consider a multi-purpose document management system (DMS) capable of multiple functions including SOP management, training and audit-ready documentation. Integrate that DMS with your Learning Management System (LMS) to assure that employees are always trained on the latest SOP. As each new version of an SOP is released, training should be automatically triggered to enable the most current, accurate understanding and compliance.
Accessibility for employees can be provided through PDAs linked to the SOP database or through dedicated computers located at key stations throughout the facility. To ensure confidentiality and data protection, access to the system can be limited by assigned passwords or fingerprint/eye recognition technology. Rank your processes by risk and invest in custom 

content and testing for the SOPs that are most important or complex. Use that risk ranking to determine which SOPs should have assessments versus “read and understand.” Finally, make sure your SOPs are understandable; many of them are not. To test the SOP’s usefulness, have an unrelated employee read the SOP and explain the procedure to you. Gaps or mistakes in the explanation will highlight where the SOP needs to be edited or rewritten. An SOP that is confusing, incomplete or inaccurate will drive parallel behaviors.

3: “We Have Absolute Confidence in Our Suppliers.”

Contract manufacturers shoulder a shifting burden of responsibility for product quality. They share the same compliance, management and workforce challenges as brand companies, but they are also bound by their customers’ demands for cost, volume, schedule and compliance. To maintain their own competitiveness, contract organizations are recognizing the value of conducting compliance training that is compatible with the systems used by their key customers. The ability to demonstrate the qualifications of its workforce to potential or existing customers is a key differentiator for contract manufacturers. Inspectional observations and warning letters from FDA increasingly cite inadequate vendor qualification, testing of incoming materials, and acceptance or rejection of active pharmaceutical ingredients (APIs). While these violations reflect poorly designed systems and inadequate oversight, they also indicate inadequate knowledge of workers assigned to those job functions. It is important to remember that the supplier you vetted in 2005 is not the same company with the same workforce today. In some instances, annual turnover can approach 100%. 

What You Can Do: Manufacturers, whether of APIs or finished pharmaceuticals, must develop effective systems for selecting and monitoring vendors, accepting and rejecting incoming product components, testing for purity and quality, and recording results in defensible formats. Vendors should be regularly monitored and periodically audited onsite. As the head of the supply chain, it is imperative for you to ensure that the workers of your suppliers are trained and compliant. As a supplier to your client, it is essential that you certify the qualifications and training of your employees. As a candidate for preferred supplier status or as a new contract partner, conducting training that is compliant with regulatory requirements and compatible with industry standards creates a competitive advantage. Increasingly, manufacturers will take responsibility for training their suppliers’ workers on cGMP protocol and company-specific SOPs, whether as a condition of vendor selection or through direct training of those suppliers. 

4: “We Have the Best-Trained Employees in the Industry”

A company that has invested millions of dollars in staff training over many years should feel confident in the ability of its workers to perform their jobs. That confidence, however, can morph into arrogance or complacency, creating a blind spot to emerging quality or compliance problems. Inadequate training is among the top violations noted in FDA’s FY 2010 Inspectional Observation Summaries. CGMP compliance requires that employers “. . . ensure that each person engaged in the manufacture processing, packing or holding of a drug product has the education, training and experience, or any combination thereof, to enable that person to perform the assigned functions.” Short version: workers have to know what they’re doing. If they don’t, it’s both a compliance and quality problem. Consider the quality implications of these recent FDA inspectional observations:

• “Employees who perform critical duties in your aseptic filling line did not participate in a . . . qualification during 2010, 2009 and 2008;”
• “Operators . . . were observed demonstrating incorrect aseptic techniques to prevent product contamination”;
• “The microbiological growth found on settle plate MS 4 was incorrectly identified and reported . . .”

When worker behavior is consistently noncompliant, training is absent or ineffective. Inevitable questions range from “Why didn’t it work?” to “Didn’t they know it wasn’t working?” Both questions indicate a dangerous gap in providing, testing, monitoring, managing and documenting training. And, that gap cannot be closed by simply adding another course, firing a handful of employees or issuing new policies. 

What You Can Do: Scour internal and external audits to identify any trends related to inadequate performance by employees based on department, subject matter, compliance requirement, facility, job function or even production line. Identify the root cause of the performance failures: confusing or out-of-date training materials, incorrect distribution, lack of comprehension, “training overload,” inadequate testing for proficiency, insufficient remedial training, lack of training reinforcement, incorrect subject matter. Then, target needed training to the learner, ensuring that it is relevant to that learner’s job function, compliance responsibilities, language, literacy and established proficiency. Test for proficiency, using forms that prevent memorization of answers or other types of cheating. Prevent learners from progressing to the next required course until testing confirms comprehension of subject matter already provided.
Provide immediate remedial training for any learner unable to demonstrate proficiency. Ensure real-time monitoring and management of all compliance training activities, giving managers the necessary tools to address emerging issues of comprehension or proficiency early. Require 

validation via e-signature for Part 11 compliance. Extend function-specific training to suppliers with the requirement that their employees demonstrate a required level of proficiency. Frame training and continual learning as core conditions of employment and advancement. Just as important, integrate versatility and flexibility that enables quick response to new needs. A role-based training program, for example, enables assignment of tailored training based on job function. An effective training matrix can be set to assign individual learning plans to groups of workers with different job responsibilities. For efficiency and effectiveness, training content should be grouped into learning plans or curricula corresponding to the qualification or certification needed by the learner. As requirements or roles change, new training programs can be automated by the company’s LMS. 

How Effective is your Training?

Quality and compliance problems are rarely caused by a few “rogue employees” or an unethical supplier who intentionally undermines the company’s processes and products. In those cases, it is obviously necessary to replace one or more employees, suppliers or vendors. Most often, compliance and quality problems are systemic issues that can be traced to inadequate knowledge, poor training and insufficient oversight.

No matter how long a compliance program has been in existence or how entrenched the company’s reputation for quality, training is only as good as the behavior it produces. Any compliance training program that fails to support the positive behavior change needed for compliance is ineffective — and it needs to change. Finally, for training programs to be truly effective, they should be continually revised and adapted to meet the needs of the industry, your business and the individual learner. 

Ellen Leinfuss is senior vice president, Life Sciences at Kaplan EduNeering. She can be reached at eleinfuss@kaplan.com.