| Life sciences organizations operating under the | | | | organizations that employ sufficient personnel with |
| current FDA umbrella of enforcement have a host of | | | | the appropriate education, background and |
| renewed challenges to ensure regulatory compliance | | | | experience. Additionally they are seeking to ensure |
| and mitigate their company's exposure to risk. The | | | | that all personnel are trained and the training is |
| "key" word here is "renewed" as most of the | | | | documented. |
| regulatory compliance guidelines for current FDA CFR | | | | Your procedures for training, management reviews, |
| regulations and Good Manufacturing Practices (or | | | | quality systems and CAPAs are all subject to FDA |
| related sister practices for clinics or labs) have been | | | | audits. Centralizing procedural management of all |
| in place for many years. | | | | these moving parts can be cost and time prohibitive, |
| Recent and frequently cited trends in FDA auditor | | | | especially if you still utilize a paper-based tracking |
| 483 inspectional warning letters have involved | | | | system. Even if you do utilize an electronic or hybrid |
| "training deficiencies". Training deficiencies were noted | | | | paper and electronic training tracking system, you |
| in 30 percent of the 97 device quality system | | | | must also consider the added hurdle of ensuring FDA |
| warning letters released the FDA in 2008, up from 22 | | | | 21 CFR Part 11 compliance for the validation of your |
| percent the year before. While FDA regulated firms | | | | electronic records. |
| are not required to respond to FDA 483 letters, it | | | | FDA regulated organizations that have already |
| obviously is good practice to do so. | | | | invested in a web-based training management |
| FDA regulated organizations can steer clear of such | | | | system or training records software program have |
| recent FDA 483 observations all together by taking a | | | | realized significant cost savings benefits by going |
| proactive stance to quality assurance through proper | | | | paperless while also making a positive impact on the |
| implementation and documentation of employee | | | | environment. Many systems that electronically track |
| training. 21 CFR 820.25 requires that all employees | | | | employee training also can enforce electronic |
| who manage, perform, or assess work affecting | | | | signatures against any document or on-the-job |
| quality must have the necessary training and | | | | training activity that ties back to an employee's |
| experience to perform their jobs related to the | | | | unique profile and record. This digital evidence can |
| quality assurance function of your operation. Here's | | | | then be queried on-demand in a very granular |
| the bottom line: FDA auditors are looking for | | | | reporting format during any audit event. |