Process Validation

Every company producing medical devices needs to understand how to practically accomplish process validation.

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.

In addition, Regulatory Affairs would benefit from understanding the expectations of Notified Bodies regarding the requirements of Annex II, Technical documentation, of the MDR. In fact, article 3(b) clearly states that “complete information and specifications, including the manufacturing processes and their validation, their adjuvants, the continuous monitoring and the final product testing. Data shall be fully included in the technical documentation”.

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.

Course benefit

Every company producing medical devices needs to understand how to practically accomplish this critical task. It is not only a regulatory requirement, but also the smartest way to understand the 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.

The course will focus on European requirements, in particular the significantly increased PMS requirements under the MDR but will also touch on US FDA expectations. This course will provide the knowledge to allow delegates to develop their own PMS strategies to meet MDR requirements and will include ample time for delegate interaction and discussion.

Course content

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. In addition, we will discuss how to link and integrate your design risk analysis with process risk analysis.

Various kinds of production equipment will be covered, including those with embedded software as well as common software packages (e.g. Microsoft Excel), and appropriate validation approaches.

We will also discuss 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.

Course language

The course will be conducted in English.

Trainer

Enzo Passalia, Quality Systems And Regulatory Specialist,
DONAWA LIFESCIENCE CONSULTING Srl, Rome, Italy

What previous participants said

Contact

Morten Petersen

Uddannelseskonsulent

49 18 47 03
mp@medicoindustrien.dk