Laboratory
Verification, Validation, Master Planning for U.S FDA and ISO 13485 Compliance
How can companies address the U.S. FDA’s tougher stance and product, process and QMS V&V? One major failing is the lack of sufficient or targeted risk-based V&V Master Planning. Why do companies need a Validation Master Plan? What is it? How is it structured? Supporting systems/documents? How should each individual V&V plan be structured? Clarification of validation terms. Device, product, proce..
Writing and Enforcing Effective Standard Operating Procedures (SOP)
This course addresses how to write effective SOPs, and work instructions in support of your company's activities.Learning ObjectivesFood and Drug Administration (FDA), the International Organization for Standardization (ISO) requirements for documentationEffective written SOPs and work instructionsMandates for documentation set forth by the regulators, such as the Food and Drug Administration (FDA), the Int..
Writing and Revising SOPs for Increased Operational Efficiency
This webinar will highlight important fundamental knowledge for writing effectively in the context of clear, concise, effective SOPs. This webinar will also help focus on an efficiency mindset that can lead to operational gains without sacrificing quality. This webinar will discuss how to more effectively write and revise standard operating procedures (SOPs) with a focus on increasing operational efficienci..
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 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..