Ms.Joy L. McElroy

This training program will list the documents required for equipment qualification and process validation and discuss how to manage documents appropriately. Attendees will gain insight into best practices for writing and maintaining a Validation Master Plan (V ...

This training program will provide the regulatory requirements for complaint handling in the pharmaceutical & medical device industries. The course will touch on complaint sources and details will be furnished on the interrelationships regarding complaint hand ...

This training program will list the documents required for equipment qualification and process validation and discuss how to manage documents appropriately. Attendees will gain insight into best practices for writing and maintaining a Validation Master Plan (V ...

This technical writing training program will offer attendees an understanding of how the reporting process supports products in research, development, and in the marketplace. This virtual session will highlight the mandates for documentation set forth by the r ...

In this webinar you will learn the FDA’s expectations of analytical equipment qualification along with the development of a sound process validation program in order to develop and implement bulletproof solutions that are accepted, effective, and efficient. We ...

After attending the 75 minute webinar, you will be able to: Identify FDA regulations and new guidance regarding quality agreements Utilize tips to help you manage quality agreements effectively Review the pitfalls to avoid when developing your program Or ...

The various regulatory agencies have expectations that suppliers and vendors will demonstrate control over their manufacturing processes, validations, and documentation. Quality auditing is the process of checking whether these organizations have implemented w ...

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 authori ...

This webinar will discuss various broad and critical aspects of an effective EM program such as the Phases of a cleanroom EM Program, Pre-Monitoring of a Cleanroom prior to Facility Validation, Facility Validation, Implementation of Routine EM using Facility V ...

The various regulatory agencies have expectations that pharmaceutical manufacturers will demonstrate control over their manufacturing processes, validations, and documentation. Quality auditing is the process of checking whether these organizations have implem ...