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What Kinds Of Training Does Your Staff Need? Warning: Reconsider Before You Say “None” Life Science Leader, April 2010 Written by: Wendy Meyeroff We take pride in hiring top-tier individuals,” says Robert Sexton, associate director/learning program leader at Novartis Pharmaceutical’s Oncology Global Development Education Office. Well, of course. Doesn’t everyone? And because everyone in biopharma hires such “top-tier individuals,” there’s no real reason to worry much about training them, right? Voiced aloud, the question probably sounds ridiculous. Yet, as we explored this topic we heard regularly that not all biopharma executives see any need for formal training of their personnel. Instead, most managers have to cull training dollars out of the overall budget of their specific departments — if they even look for the money.
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Where Training Is Needed There is actually an astonishing array of issues in which biopharma personnel need training. Some are clinical, such as meeting lab cleaning compliance issues, understanding and meeting FDA requirements for product safety, and understanding specifics on coping with EU regs. Others are more business-oriented, such as managing your lab, writing effective SOPs and procedural documents, and applying good manufacturing practices (GMPs). Understanding the latter, experts agree, is a major factor in receiving approval for any biopharma product brought to market. Despite all these needs, many companies only come (often reluctantly) to training in response to outside regulatory pressures. Other times, courses are sought or established through corporate insight, as was Sexton’s situation. His job, in a department created only about a year ago, involves ascertaining the best training method for whatever needs to be taught to his group and providing it. Why even create such a learning department? “It was determined that we needed organizational agility that promoted rapid deployment of new techniques, new knowledge in anything. It could be in computer use, new management skills, or new methods of clinical development,” says Sexton. “As those changes come about, we want to ensure our people have the information they need to implement them expeditiously.” Definite Cost Concerns “Upper management often sees training as an unnecessary expense on the bottom line,” says Bill Beyer, director of marketing at the Center for Professional Innovation and Education (CfPIE). CfPIE supplies training and certification in biotech/pharmaceuticals, medical devices, and skin/cosmetics products. The expense of training was a concern even before the recession, but it’s been exacerbated over the last few years. Two- or three-day training sessions can cost from $1,800 to over $2,500 per person — and that’s just the class fee. When a class is off-site, there are additional expenses such as transportation, meals, and housing. Leslie Orischak understands the financial pinch of training even more acutely than many larger companies. That’s because she is the VP/general manager of Puresyn, a nine-person company in Malvern, PA, that provides proprietary polymer technology for the separation and purification of nucleic acids and other biological molecules. “We don’t have budgeted training money, so we obtain state grants for training,” she says. There are also less tangible costs to training, such as those Sexton faces when choosing options for high-level personnel such as clinical trial managers, outsourcing managers, and doctors (e.g. M.D.s) who are program leaders. Feedback from these people indicated a need for a course on managing interactions with their clinical research http://www.lifescienceleader.com/index.php?option=com_jambozine&layout=article&view=page&aid=4007
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