Short Abstract

Per the Code of Federal Regulations (CFR), Title 21 CFR Part 211, “procedure” is stated 71 times and “Written procedures shall be followed” is stated 19 times within Subpart B-Organization and Personnel, Subpart C-Buildings and Facilities, Subpart E-Control of Components and Drug Product and Containers, Subpart-F Production and Process Control, Subpart-G Packaging and Labeling Control, Subpart H-Holding and Distribution, Subpart-I Laboratory Controls, Subpart-J Records and Reports. Clearly, the emphasis placed on procedural expectations within the CFR is indicative of the importance of written procedures, as they are the quintessential GMP foundation for an organization to control validated processes and have traceability to meet all other GMP requirements, from GMP documentation, maintaining GMP compliance, during both commercial operations, research and development, deviation investigation management, effective Corrective Actions Preventive Actions (CAPA) management, change controls, clinical and regulatory affairs, training to an essential role in managing human error. Use the knowledge and tools provided in this course to start moving your organization from “reactive/CA” focused tasks to “preventive/PA” tasks.

A preventive focused organization will reap substantial financial benefits, successful regulatory audits and even increased employee moral and retention, all are COST SAVINGS, while most importantly, increasing protection of public health!

Areas Covered in Webinar:

• DISCOVER a proven method to ensure Standard Operating Procedures (SOPs) are Title 21 CFR Part 211 compliant, able to be followed and are always followed
• INCREASE depth of staffs’ GMP knowledge and ability to successfully apply, create & maintain compliant quality systems
• LEARN how to conduct Task Analysis for controlled instructional documents
• KNOW how to design an effective and compliant document control system
• LEARN and IMPLEMENT a method, proven successful for 20+ years in North America Commercial Nuclear and Military Aviation, prescribing procedure usage rules, which includes accounting for the environment in which the procedures must be used in order to be followed (human factored), define use of error prevention techniques during review and approval because “…shall be followed is a directive, NOT a method to achieve “…shall be followed.”