Overview: This course provides regulatory/quality professionals, manufacturing engineers, and process development engineers with the knowledge and skills needed to comply with the process validation ...

Jim Mencel is Senior Drug Substance Consultant at Design Space InPharmatics. With an extensive background in CMC management, Jim has a wealth of knowledge on the topic of process validation. Process ...

Process validations are crucial when assessing and mitigating risks associated with manufactured medical devices. Basic steps can also be taken to improve problem-solving and root cause analysis. To ...

Microbial process validation contributes significantly to ensuring that a food process or is capable of effectively mitigating a microbial hazard. The ability of a process to inactivate a target ...

Developing a medical device is a lengthy process. Prior to commercial distribution, FDA requires that the manufacturing process for the product be validated. Process validation is defined as the ...