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 ...
Compliant documentation in the drug manufacturing process is essential. 21 CFR Part 11 compliance software helps achieve this from raw materials to finished goods. In addition, the qualifications of ...
In its 2011 Guidance for Industry on Principles and Practice of Process Validation (1), FDA radically changed its interpretation of process validation. Validation now means “the collection and ...
Industry experts discuss the effect FDA's 2011 process validation guidance has had on industry. In the two years since the publication of FDA's final process validation guidance, how has this new ...
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 ...
Course "Analytical Instrument Qualification and Validation: Understanding to Prepare for FDA Audits to become Part 11 Compliant" has been pre-approved by RAPS as eligible for up to 12 credits towards ...
Laser micromachining is a versatile process that can be used for an array of medtech applications. Yet when using it, it is crucial to select the appropriate method of process qualification or ...
This suite automates the commissioning, qualification, and validation (CQV) of processes, equipment, and systems. It includes three AI-enabled applications: Together, these systems work in tandem 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 ...
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