"The teacher was very good. Bea Salis focused on the methods we all have to use in our daily work and not a lot on the rules behind. More on the tools we can use and what is necessary according to the FDA" Course participant, May 2010
Who should attend?
Since process validation sets the stage for ongoing defect-free production of medical devices, many departments are involved. Manufacturing and engineering have major roles to play, but personnel from QA and R&D are generally involved. Anyone who is involved in these activities or is responsible for auditing this function will benefit from this practical approach to performing validations and the documents that provide the proof of compliance.
Every company producing medical devices needs to understand how to practically accomplish this critical task. It is not only a regulatory requirement, but is the smartest way to understand the a process and from that understanding, determine process controls and methods to create the most reliable process while will in turn produce the safest and most reliable devices at a lower cost. The goal of the course is to provide a clear understanding of what has to be validated, when it needs to be done, and particularly how to do it, including developing good documentation to provide the evidence of compliance to requirements.
We will discuss current regulatory requirements and guidance documents, as well as the preparation of good documentation, including the SOP, protocols and reports. Attendees will be encouraged to bring these documents to the class for their personal development of these documents during the course. Understanding all the variation in any process will be discussed as a way to determine validation approaches.
We will talk about creating a Master Validation Plan and how to put it into effect in a practical way.
Various kinds of production equipment will be covered, including those with embedded software, and appropriate validation approaches.
We will also work through some practical examples of how to perform and document an IQ, OQ and PQ and how to determine when to revalidate.
The impact of equipment maintenance will also be covered including how to determine appropriate process controls once the process has been validated.
The course will be conducted in English.