Complying with GLP regulations always entails GLP training. For example, GLP training is required “in bits and pieces” throughout the 21 CFR Part 58 regulations, and when those bits and pieces are combined, its easy to see that GLP training requirements result in an obvious need for the improved management of GLP training processes across a variety of industries.

GLP Training Requirements

Those GLP training requirements found in part 58 start with section 58.29(a), which essentially states that anyone who has any responsibility for conduct or supervision in a nonclinical research laboratory must have “the education, training, and experience, or combination thereof”1 that he or she will need to do his or her job correctly. This requirement seems simple enough but actually becomes increasingly complex as part 58 continues to unravel.

What are the complications?

The only complications that may result from section 58.29(a) (or at least the obvious ones) would be 1) creating a hiring process that results in the right personnel according to Part 58 requirements, and 2) ensuring that the hiring process doesn’t overshadow the need to account for the necessary skills and personality factors that are essential to the health of any company and not just the necessary GLP training justification.

What are the solutions?

Solutions should include the thoughtful creation of job descriptions, which should in turn include the exact education, experience and training that each job will entail. Standards for measuring these factors should also be considered/documented and those in charge of hiring should be selected–to at least some degree–for their ability, or potential ability, to discern skills and personality factors that could influence the work place. It is also important that hiring decisions are not based on the opinions of one person alone. Hiring decisions should be made by at least two informed personnel members.

Sec 58.29(b): GLP Training and Document Management

Sec 58.29(b) begins to construct additional GLP training complexities with a demand for training related document management. For instance, this section requires that every nonclinical research facility “maintain a current summary of training and experience and job description for each individual engaged in or supervising the conduct of a nonclinical laboratory study.”

What are the complications?

Sec 58.29(b) opens the door for complications that seem almost infinitely complex. For instance many companies will manage their GLP training documents manually. Manual management is a complication in itself because it leads to lost paperwork, paperwork that is hard to find (i.e. in filing cabinets, in network folders, etc.) and paperwork that is difficult to edit quickly and difficult to route (for approvals) quickly. These difficulties obviously result in more wasted time from employees, and eventually, more revenue to support that time.

What are the solutions?

One solution to consider would be to automate the documents associated with GLP training management processes with a software solution(s) designed for that purpose. Companies should search for a software solution that will automate routing procedures, provide document version control and make documents easy to track down and edit. Companies should also search for a solution that automates tasks and processes associated with GLP training. The solution should include for instance the capability of providing digital audit trails for training related data and allowing the quick management of follow-ups, escalations, etc.

Sec 58.29(d)

Sec 58.29(d) implies training in the sense that it requires that “personnel shall take necessary personal sanitation and health precautions designed to avoid contamination of test and control articles and test systems.”

What are the complications?

Complications with sanitation are not the issue here! The complication is that training can simply be difficult to coordinate and GLP training holds no distinction. A simple personal sanitation/health training session required by GLP regulations can turn into a training nightmare when employees are not notified, when employees simply don’t show up for training, and worst of all, when training records are not kept, maintained, stored or retrieved appropriately.

What are the solutions?

The solution for any type of training coordination is to manage training data and employee training responsibilities and records electronically. This can be accomplished with a training solution that sends emails to all those requiring GLP training and provides subsequent follow-ups and escalations if necessary. Digital audit trails are also valuable in a training solution of this nature.

Conclusion

For many companies, GLP training processes are simply in need of an overhaul and surprisingly enough establishing streamlined GLP training processes can be much easier than most companies realize.

1All quotations in this article were extracted from the following online content on Feb. 19, 2008: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=58&showFR=1