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Volume 29, Issue 12
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses training personnel on a limited budget.
A: This is a great question. It seems cutting the training and travel budgets are the first austerity measure companies take when they are facing some budgetary difficulties. In my opinion, training should probably be one of the last areas that should have its budget cut because training is one of the key elements management can use to assure their commitment to consistently producing a high-quality product. It is also a GMP requirement.
The US regulations, 21 Code of Federal Regulations (CFR) 211.25, define personnel qualifications and state, “Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performs and in current good manufacturing practice (including the current good manufacturing practice regulations in this chapter and written procedures required by these regulations) as they relate to the employee’s functions. Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them” (1).
Just because your budget is cut, however, doesn’t mean you can’t make sure employees receive meaningful training. There are many organizations and companies that offer webinar training on topics ranging from “How to Write Effective SOPs” to “How to Perform an Effective Technology Transfer” to “Risk Management Strategies for Quality Management in the Pharmaceutical Industry.” Some of these webinars are free and some require a registration fee. They are usually 90 minutes in length, and many offer an opportunity to ask the speakers questions through a chatroom feature. If you are unable to listen to the webinar live, you may have the option to purchase a recording of it and listen to it at your convenience. The recorded option offered with these webinars can be valuable for training employees who work on the second and third shifts that can often be challenging. The companies offering these webinars advertise them well in advance of the event and often send out multiple reminders. The advertising for the webinars highlight who will be speaking, their qualifications, what they will cover in the training, and what you will learn as a participant. In addition, they will also make recommendations on who should attend so you can determine if this is appropriate training for your employees. In some cases, the webinar may offer continuing education credits for attending. This information should be printed out and used to demonstrate the appropriateness of the training during an audit.
FDA also offers training through the FDA Learning Portal for Students, Academia and Industry at www.fda.gov/Training/learningportal. This training, FDA reports, “… provides educational resources related to FDA’s regulatory, product quality, and safety responsibilities. In each section you’ll find educational materials such as lectures and courses as well as web pages related to the particular topic.”
Some of the topics available include courses titled FDA 101, FDA’s Regulatory Framework, Current Initiatives, Human Drug Approval and Post-marketing. The modules also provide a course objective so you and your employees will understand what they should know after completing the training. For example, there is also a module called A Tour of FDA, which, FDA states, will provide an understanding of FDA’s public health mission and how the agency is organized to carry out its mission (2). FDA also broadcasts some of its public meetings depending on the topic.
The agency’s public meeting regarding its Request for Quality Metrics Guidance for Industry was a great way to learn about the new guidance and what industry colleagues were thinking. This is another way employees can keep up-to-date on the current issues facing the industry.
Finally, for some employee groups, internal training consisting of discussions of current topics that can be found from industry warning letters, 483s, or new guidance documents may be a low-cost alternative to a formal training experience. These discussions can be led by qualified company personnel and can cover not only the specifics of the issues but the rationale behind them. As with all other training, these discussions should be documented in your training system.
The bottom line is even though your budget has been cut there are still opportunities to get your employees the required needed training that will satisfy your customers in audits. You should sign up to receive emails from companies and organizations that offer online training, review them to determine if they are applicable to your operations, determine who should attend from your company, and make sure you document their attendance for their training record. In addition, you should also monitor the FDA website for potential upcoming webcasts, past webcasts, and other public offerings that will help you and your employees receive the necessary training even with a limited budget.
1. 21 CFR 211.25, Personnel qualifications, April 1, 2016.
2. FDA, FDA Education and Resources by Subject, www.fda.gov/Training/learningportal/ucm417363.htm#overview
Vol. 29, No. 12
Pages: 58, 57
When referring to this article, please cite it as "Options in Employee Training," BioPharm International 29 (12) December 2016.