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Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.
Establishing a well-defined training program is a crucial activity for any biopharmaceutical organization.
Training represents one of the key elements that management can use to assure a consistent, high quality, product. Codifying the elements of the training program will help a company maintain compliance to the regulations and address regulatory concerns about employee qualifications that might arise during inspections. Some companies are fortunate to have either a training department or a training coordinator to define and administer the program. Companies that do not have either should establish a training team with representatives from the quality assurance, quality control, and operations departments at a minimum. There should be approximately four parts to any training program: the introductory training requirements for new employees, the annual training requirements for all employees regardless of function, the continuing education training expectations, and special training requirements that may be required for continuous quality and process improvements. The first three may be tracked with a training matrix.
Introductory training requirements
New employees should be initially trained on applicable GMPs, good documentation practices (GDPs), and any additional global requirements impacting their jobs. It is prudent for a company to develop a quiz or test to demonstrate the new employee’s comprehension of these basic requirements with an established minimum passing percentage. The minimum percentage must be achieved before the employee is considered to have the basic knowledge needed to work in the company. Incorrect answers should be discussed as part of the process. If the required minimum is not achieved, the prospective employee should be provided additional instruction on the material and a different test should be employed to measure comprehension. If the minimum required comprehension level is still not achieved, the quality assurance department should inform the hiring manager and indicate the new employee is not suitable for employment. Once new employees have passed the minimum understanding requirements on the quizzes, they should then be trained on company policies and specific job-related standard operating procedures (SOPs).
Annual training requirements
Companies should perform annual refresher training on a variety of topics. At a minimum, it is recommended that employees be retrained annually on cGMPs and cGDPs. Additional yearly training topics could be tailored to the type of operations being conducted at the facility. If the company is manufacturing parenteral products, the annual training program might include modules on microbiological control in aseptic manufacturing and conducting investigations/root cause analysis. This yearly training should also measure employee comprehension of the material. This comprehension might be measured in a variety of ways including but not limited to written quizzes, oral quizzes, and hands-on demonstration. Whichever way is chosen to assess the employee’s comprehension of the material, it should be noted on individual training records
Continuing education training requirements
Employees should be encouraged to enhance their job-specific knowledge and skills by attending external training conferences, seminars, and activities. The training team should be responsible for reviewing literature and recommending which employees should attend specific courses to enhance their skills and knowledge. The benefits of the external training should be discussed with senior management. There are several organizations that provide seminars, training classes, and symposia including the American Society for Quality, the Parenteral Drug Association, the American Chemical Society, and for-profit organizations.
Companies need to recognize there may be occasions when special training is required for employees. The responsibility for determining the need for special training will reside with the training team but should be performed using qualified trainers with recognized expertise in the specific discipline being addressed. Using qualified trainers in this situation assures the attendees will be trained by experts that will understand questions that may arise during training. As with all training, a record of the training should be put into the employee’s personnel folder.
When a company invests in the future of its employees by establishing a comprehensive training program, they need evidence that the monies were well spent. To assure continued funding for training, management should establish metrics to monitor performance as a practical measure of the ongoing effectiveness of training activities. By continuing to invest in training, companies invest in their employee’s futures
and develop a knowledgeable, skilled and experienced workplace as well as a culture supporting continual improvement and growth.
About the Author
Susan J. Schniepp is vice-president of quality and regulatory affairs at Allergy Laboratories.