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 ...

Incorporating Q8, Q9, Q10 into good manufacturing practices (GMP), guidance on process validation, health based exposure limits covering cleaning validation and computerized system validation are the ...

Training evaluation is the process that examines the effectiveness of your educational and training programs. Validation is the process that certifies the training employees are receiving meets ...

The track by which API manufacturing processes are prepared for commercial use is comparable to overlapping integrative process evaluations at commercial scale. This ensures the process is ...

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 ...

European Medicines Agency (EMA) which has been following the US FDA guidelines on Process validation so long, has now revised the process validation norms. The revision incorporates the principles of ...

Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...

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 ...

Medical device equipment manufacturers work in an environment where product quality isn't just a competitive advantage, it's a regulatory necessity with direct implications for patient safety. As ...

A moldmaker said recently that it sometimes takes him up to eight months to validate a large, high-cavity medical mold. Maybe this surprises you, but it doesn’t surprise many OEMs in the medical and ...