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 ...

Undertaking process validation involves a major commitment in terms of personnel, resources, time, and money. Performing prerequisite verifications can reduce the risk of making costly mistakes. This ...

Managing data at the different stages of the lifecycle, linking disparate systems together, and making the right data available to those who need it is problematic and time consuming. The ...

In biopharmaceutical manufacturing, consistency is vital but hard to achieve. Turning raw materials into safe, high-quality medicines requires stable processes. However, the living cellular expression ...

This program opens opportunities in enhancing statistical skills for validation projects, focusing on variance, sample distributions, and process capability, which are crucial for setting acceptance ...

Dublin, Jan. 13, 2023 (GLOBE NEWSWIRE) -- The "Latest Process Validation Guidance Requirements course (FDA and EU Annex 15: Qualifications and Validation)" training has been added to ...

VP and CISO for Mandiant, helping guide the company's product and solutions strategy and host of the Cyber Security Effectiveness Podcast. Understanding the effectiveness of your company's security ...