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Overview: This presentation will answer some of the frequent questions of new trainers or training managers. These include: worker training requirements, the frequency of training, how to design an effective training program, who is responsible for training, training effectiveness and training documentation. By examining the GMP expectations on training from different regulatory bodies (from the regulations and citations), attendees will be able to envision what to include in a GMP training program. In addition, an overview of the training system, including types of training planning, will offer considerations to make GMP training more effective. Why you should attend: Regulatory agencies around the world require that training on good manufacturing practices (GMP) be conducted on a regular basis for those who are involved in producing pharmaceutical and biological products. Documentation is also needed as evidence that the training occurred. More and more frequently, regulatory agencies and their inspectors are requesting evidence that the training was effective. While regulatory agencies have these requirements and expectations, they give few specific details as to how the training is to be performed; they do not say how it should be done. To date, no guidance document on training for industry has been available from any regulatory agency or official (governmental, nongovernmental or industrial) organization. Unfortunately, this lack of guidance may cause some in industry to think that training is a simple process. However, for training to be an effective and efficient tool that contributes to performance, it must be done properly. Areas Covered in the Session: Review of GMP regulatory expectations of training (FDA and EU) Recent training-related citations High-Level description of a training system, including elements (needs analysis through evaluation), basic training documentation, management, GMP training plans/planning, and trainers Who Will Benefit: Training Managers and Directors Trainers Regulatory Affairs specialists Quality Unit managers and supervisors (QC/QA) Kerry gained his pharmaceutical manufacturing experience during his 28-year career with Merck. His career spanned the areas of Quality Operations, Audits & Inspections, Laboratory, Human Resources, and Learning & Development. More specifically, his responsibilities included quality management of laboratory assessment, site GMP lead auditor, FDA QSIT/Quality Management System manager, 5S coordinator, GMP trainer (annual, ongoing, new hire), OSHA regulations and Process Safety Management training, as well as internal and external public relations. Contact Information: NetZealous LLC, DBA GlobalCompliancePanel 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA USA Phone:800-447-9407 Fax: 302-288-6884 webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com Event Link - http://bit.ly/1hcuTLE
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