| Complying with GLP regulations always entails GLP | | | | itself because it leads to lost paperwork, paperwork |
| training. For example, GLP training is required "in bits | | | | that is hard to find (i.e. in filing cabinets, in network |
| and pieces" throughout the 21 CFR Part 58 | | | | folders, etc.) and paperwork that is difficult to edit |
| regulations, and when those bits and pieces are | | | | quickly and difficult to route (for approvals) quickly. |
| combined, its easy to see that GLP training | | | | These difficulties obviously result in more wasted |
| requirements result in an obvious need for the | | | | time from employees, and eventually, more revenue |
| improved management of GLP training processes | | | | to support that time. |
| across a variety of industries. | | | | What are the solutions? |
| GLP Training Requirements | | | | One solution to consider would be to automate the |
| Those GLP training requirements found in part 58 | | | | documents associated with GLP training management |
| start with section 58.29(a), which essentially states | | | | processes with a software solution(s) designed for |
| that anyone who has any responsibility for conduct | | | | that purpose. Companies should search for a |
| or supervision in a nonclinical research laboratory must | | | | software solution that will automate routing |
| have "the education, training, and experience, or | | | | procedures, provide document version control and |
| combination thereof"1 that he or she will need to do | | | | make documents easy to track down and edit. |
| his or her job correctly. This requirement seems | | | | Companies should also search for a solution that |
| simple enough but actually becomes increasingly | | | | automates tasks and processes associated with GLP |
| complex as part 58 continues to unravel. | | | | training. The solution should include for instance the |
| What are the complications? | | | | capability of providing digital audit trails for training |
| The only complications that may result from section | | | | related data and allowing the quick management of |
| 58.29(a) (or at least the obvious ones) would be 1) | | | | follow-ups, escalations, etc. |
| creating a hiring process that results in the right | | | | Sec 58.29(d) |
| personnel according to Part 58 requirements, and 2) | | | | Sec 58.29(d) implies training in the sense that it |
| ensuring that the hiring process doesn't overshadow | | | | requires that "personnel shall take necessary personal |
| the need to account for the necessary skills and | | | | sanitation and health precautions designed to avoid |
| personality factors that are essential to the health of | | | | contamination of test and control articles and test |
| any company and not just the necessary GLP training | | | | systems." |
| justification. | | | | What are the complications? |
| What are the solutions? | | | | Complications with sanitation are not the issue here! |
| Solutions should include the thoughtful creation of job | | | | The complication is that training can simply be difficult |
| descriptions, which should in turn include the exact | | | | to coordinate and GLP training holds no distinction. A |
| education, experience and training that each job will | | | | simple personal sanitation/health training session |
| entail. Standards for measuring these factors should | | | | required by GLP regulations can turn into a training |
| also be considered/documented and those in charge | | | | nightmare when employees are not notified, when |
| of hiring should be selected--to at least some | | | | employees simply don't show up for training, and |
| degree--for their ability, or potential ability, to discern | | | | worst of all, when training records are not kept, |
| skills and personality factors that could influence the | | | | maintained, stored or retrieved appropriately. |
| work place. It is also important that hiring decisions | | | | What are the solutions? |
| are not based on the opinions of one person alone. | | | | The solution for any type of training coordination is |
| Hiring decisions should be made by at least two | | | | to manage training data and employee training |
| informed personnel members. | | | | responsibilities and records electronically. This can be |
| Sec 58.29(b): GLP Training and Document | | | | accomplished with a training solution that sends emails |
| Management | | | | to all those requiring GLP training and provides |
| Sec 58.29(b) begins to construct additional GLP | | | | subsequent follow-ups and escalations if necessary. |
| training complexities with a demand for training | | | | Digital audit trails are also valuable in a training solution |
| related document management. For instance, this | | | | of this nature. |
| section requires that every nonclinical research facility | | | | Conclusion |
| "maintain a current summary of training and | | | | For many companies, GLP training processes are |
| experience and job description for each individual | | | | simply in need of an overhaul and surprisingly enough |
| engaged in or supervising the conduct of a nonclinical | | | | establishing streamlined GLP training processes can be |
| laboratory study." | | | | much easier than most companies realize. |
| What are the complications? | | | | 1All quotations in this article were extracted from the |
| Sec 58.29(b) opens the door for complications that | | | | following online content on Feb. 19, 2008: |
| seem almost infinitely complex. For instance many | | | | accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr |
| companies will manage their GLP training documents | | | | CFRSearch.cfm? |
| manually. Manual management is a complication in | | | | |