Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform. Still, it is not widely understood how the writing of a procedure can have a positive or negative impact on training or employee performance, and as a result, training often misses the mark or employees make mistakes that could have been avoided with better synchronization between the activities of the documentation and training groups.
This session is designed to assist learners with the following objectives:
In this course, you will learn the vital connection between documentation and training, and how to maximize this connection to improve the quality of both SOPs and training, as well as job performance. This course is geared toward the pharmaceutical industry, particularly those areas which develop SOPs for the manufacturing or quality monitoring of pharmaceutical products, as well as Information Technology (IT).
The content will be especially beneficial for anyone who is an owner of a process, is responsible for writing or reviewing procedures, and/or manages training in a GMP environment. The course aims to provide practical information, which has already been used on the job effectively and suggests similar actions that learners can apply to their job situations quickly.
Michael Esposito has 30 years experience in the pharmaceutical industry and 13 years of experience in GMP training and document management. He has worked for Wyeth Pharmaceuticals, Pfizer, and Johnson & Johnson’s McNeil Consumer Healthcare Division in a variety of areas including packaging, project administration, quality assurance, Government Contracts, translations, systems training, and international operations.
He collaborated in the development and implementation of the training portion of the Consent Decree work plan for McNeil and revised their introductory GMP course. He is a member of the training organization GMP TEA and is fully fluent in Spanish. His areas of interest include systems training, training effectiveness, post-training user support, process improvement, and sustainable packaging.