Key Factors to Write an Effective Standard Operating Procedure (SOP) (Pharmaceutical Train)
Venue: Online Event
|Event Date/Time: Sep 09, 2010||End Date/Time: Sep 09, 2010|
Current Good Manufacturing Practices (cGMPs) continue to be the standard practices in the pharmaceutical industry. Each company must develop their own set of Standard Operating Procedures (SOPs) based on cGMPs; however, most of warning letters and regulatory observations are due to non-adherence to SOPs. This discussion will bring up several key factors to develop a comprehensive, consistent SOP. It will define critical elements of a structure SOP to make it easier to understand, follow and review by operating personnel. It will also discuss the consequences of SOP misuse and benefits of an effective training program.
Upon completion of this session, attendees will understand the requirement of SOPs and their roles in the day-to-day operations. It will go over the key factors to structure an SOP and present the consequences of over- or under-documentation. It also discusses benefit of a good training program to minimize compliance infractions.
Areas Covered in the Seminar:
Define elements of an SOP.
Establish SOP change control system.
Ensure that the instructions and details in the SOPs are sufficient and consistent.
Train personnel on reviewing and understanding the SOPs.
Develop an effective and comprehensive training program.