QPharma is an industry leader in the development and deployment of Facility, Equipment, and Utility system qualification and validation projects for pharmaceutical, biopharmaceutical, and medical device companies, including related process validation. Our FEU teams have extensive experience in both project planning and execution. QPharma personnel have served as committee members for USP, ISPE, and ASQ; been lead authors of FDA and PHS Public Docket responses; and led meetings and conferences on validation for ISPE, ASQ, RAPS, PhRMA, Advamed, and PDA.
In addition to our qualification services, QPharma conducts industry training, through forums and in partnership with industry groups and FDA, on validation in numerous disciplines, including CSV, Cleaning, Sterilization, Process Validation, Analytical Methods, Life Sciences project management, Part 11 compliance, and numerous other topics of current interest to the industry.
Solutions For Complete Project Planning And Execution:
- Equipment validation
- Utility system validation
- Computer system validation
- SOP development
- Preparation and review of plans and protocol
- Clean rooms (compliance with U.S. and EU regulations)
- Good engineering practices
- QA and technical reviews
To learn more about QPharma’s commitment to best-in-class Facilities, Utilities, and Equipment compliance, please contact us.