Medical Devices
What to Expect with the New FSMA Internal Adulteration Regulation
IA establishes requirements to prevent or significantly minimize acts intended to cause wide-scale public health harm. The session will explain coverage, summarize requirements for facilities that manufacture, process, pack or hold human food. Also, exemptions will be discussed as well as best practice approaches and Food Defense Qualified Individual detail.Areas Covered Food defense plan..
Writing Effective Standard Operating Procedures and Work Instructions
Standard Operating Procedures and work instructions – the documentation required by regulation – are essential to the effective and compliant running of any regulated business. Unfortunately, many individuals in those businesses miss the valuable opportunities that properly developed Standard Operating Procedures/Work Instructions can provide. Regulated documentation can serve a variety of purposes other th..
Writing SOPs to Enhance Understanding and Compliance
Almost every paragraph of the Quality System Regulation states that manufacturers shall “establish” procedures. This webinar will help you to write complete, clear, unambiguous, and flexible SOPs that accomplish that objective. You will learn techniques for creating concise and easy-to-read SOPs that your employees can understand and will follow. Well-written SOPs result in more consistent process output an..
Writing Validation Master Plans: Best Practices for Authoring a Compliant Document
This webinar will discuss the major components of Validation Master Plans. It will discuss how the VMP is different from Validation SOPs. Various regulatory requirements for Validation Master Plans will be discussed as well as effective guidelines for authoring a VMP and a team writing approach to authoring a Validation Master Plans will be discussed. Various types and examples of VMPs will be given and dis..
Writing World Class Compliance Documentation
Standard operating procedures and work instructions can be an effective tool in the control and standardization of operations, the conduct of training, the meeting of all regulatory requirements, and as user support tools to guide individual performance and to manage the execution of that performance. The key is in knowing how to apply the proper techniques to their creation.Standard Operating Procedures an..
Developing A Strategic Approach To FDA Compliance For Computer Systems
This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems subject to FDA regulations. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do. It also ensures that a system is ma..