Malcom Associates | SOP Training Workshops
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SOP Training Workshops

The SOP development/re-write training workshops are based on the results of an initial review of the current SOPs to be simplified and based on the “Guidance for Writing SOPs”.  The SOP development/re-write and training is conducted with designated participants to communicate and practice the concepts for simplification and consolidation of the SOPs.

The SOP development/re-write and training workshops cover:

  • Applying basic and consistent rules and techniques when authoring procedures based on the “Guidance for Writing SOPs” and other applicable site procedures
  • Practicing the use of these rules through the redesign of an SOP(s) by each participant during the course of the workshop
  • As applicable, conducting workplace observations to understand the process workflows, documentation requirements, and to verify task analysis steps with the subject-matter experts (SMEs)
  • Evaluating requirements for Competency Evaluations (KTA – Knowledge Transfer Assessment) on work instructions applicable to critical tasks that impact product quality, process control, and cGMP compliance
  • Incorporating as applicable, any outstanding CAPAs and/or resolve gaps identified between current and new improved SOPs
  • Adding where appropriate, diagrams, pictures, and symbols in the work instructions
  • Conducting desk-top reviews with other process SMEs of the draft documents to answer questions, obtain comments, recommendations, and agreement

After completing the workshop, participants will:

  • Demonstrate and understand the importance of identifying the information and training required for the employees who will perform the tasks associated with each procedure
  • Demonstrate and understand how to apply the information defined in the Guidance for Writing SOPs. (i.e. using a common format, content, and process to provide a consistent level of detail where applicable
  • Demonstrate and understand the tasks that are associated with the SOP being authored and ensuring that the procedure for performing the tasks are adequately covered by the SOP or by reference to another SOP
  • Ensure that when an SOP is referenced in a Batch Record, that the SOP includes the specific information and instructions that enable the employee to satisfactorily perform the task and meet cGMP and quality standards
  • Demonstrate the ability to properly identify information that belongs in the SOP