All FDA Regulated Industry
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..
You Must Comply With the USDA Final Genetically Modified Organism (GMO) Label Rule
The need for GMO labeling has been a hot topic for over 15 years. Scientific inquiry regarding the safety of GMO products has generated more questions that have been answered and has added fuel to the controversy.After extensive review and industry input, the National Bioengineered Food Disclosure Law) PL114-216) was signed into law on July 2016. The rules impact many types of food including beer, dairy pro..
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..