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Data Integrity: FDA 483s and Warning Letter Trends
As the FDA continues to ramp up its data integrity enforcement efforts, companies in the pharma, biotech, and food manufacturing
FDA GUIDANCE AND STANDARDS
In December 2018, the FDA issued draft guidance intended to help pharmaceutical companies comply with current good manufacturing practice (cGMP)
Challenges with Laboratory Data Integrity and Compliance
Interview Transcript: Mack Powers (00:07):We’re here with Mitchell Wheeler today. Mitchell, it’s great to be talking to you. Mitchell is
Maintaining Quality while reducing cycle times during the Clean in Place process
Interview Transcript: Mack Powers (00:07):So Tom, it’s good having you again today. You and I have been talking about CIP
Inspections and Audits – How to interact with health authorities
Interview Transcript: Mack Powers (00:07):All right, Wendy. It’s great to be back with you today and chatting with you about
Impacting Human Health – A Discussion with Dr. Wendy Haines – Board Certified Toxicologist
What are the 4 T’s of a Clean In Place (CIP) System?
Interview Transcript: Mack Powers (00:08):Hey, welcome today. I’m Mack Powers. I’m with Tom Whiteley. Today we’re going to be talking
How Integrao helps pharmaceutical, biotechnology, and food and beverage manufacturers resolve contamination issues
Interview Transcript: Mack Powers (00:07):Okay. I’m here with Tom Whitely today. We’re talking about contamination in pharmaceutical facilities. Contamination really
What do you do when you run out of engineering horsepower?
How Integrao supports clients by providing engineering resources for projects and challenges. Interview Transcript: Mack Powers (00:01):So you might have
Commissioning and Qualification
Commissioning and qualification (C&Q) are terms and processes related to the manufacturing of pharmaceutical or biotechnology products. Each term represents
4 Ways an Effective Validation Master Plan Can Impact Your Project
Validation, a requirement of the FDA, is an all-encompassing program that ensures your manufacturing facility’s equipment and processes function properly,
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