Attend this webinar to improve the writing of both SOPs and training materials for more effective training and reduction of errors.Define the parameters of an effective SOPHow your foundation keeps subsequent steps from going awry-preventing “garbage in”Interact with the SOP process owner/author to improve the writing of procedures
Regulatory requirements for SOPsDefine the parameters of an effective SOP – how your foundation keeps subsequent steps from going awry – preventing “garbage in”Why bad procedures have a negative impact on trainingWhat identifies a bad procedureIdentify appropriate level of detail for documentHow the training department needs to be in the loop at the start of the SOP development processWhat SOP writers and approvers need to keep in mind for retention of the content at the training stage
Translate the SOP into effective curriculum development and training executionConsiderations related to curricula and Learning Management Systems (LMSs)Considerations for training: reading of SOPs with assessments and/or classroom trainingPerform an ongoing assessment of the knowledge retention of learners for continuous improvement
Translate the SOP into effective curriculum development and training executionThe implications of good training for successful SOP executionHow the SOP wording can be “translated” into language that is appropriate for learners if a presentation, computer-based training or classroom session is to be developedPerform an ongoing assessment of the knowledge retention of learners for continuous improvementUse several different methodsTake advantage of tools that already exist in your organizationReview of learning objectives
This course will be of benefit to anyone who is an owner of a process, responsible for writing or reviewing procedures, and/or managing training in a GMP environment.Pharmaceutical industry- particularly those areas that develop SOPs for the manufacturing or quality monitoring of pharmaceutical products, which would also include Information Technology (IT) employees who manage systems trainingQuality DepartmentsProduction DepartmentsCompliance DepartmentsEngineering DepartmentsR & D DepartmentsManagement – essentially everyone in the organization who is tasked with creating or reviewing procedures
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.