Why Get Certified? Certification is a way to demonstrate to your current and future employers, your coworkers, and your auditees that you have mastered a defined Body of Knowledge (BOK) through studying, testing, and work experience. You can use your certification to demonstrate increased competency and get promotions and pay raises. A recent survey reported in ASQ’s Quality Progress… [Read More…]
5 Questions You Should Ask Your GLP & GCP Labs (and the answers you need to know)
1. What are the records? Records include more than the final assay results. For example, they can include audit trails, QC results, user access control lists, and configuration settings. Review the manufacturers’ user and administrator manuals to identify records the instruments create, modify, maintain, or transmit. Ask for a guided tour of the validation / qualification… [Read More…]
The Top 3 Actions You Can Take To Protect Your Company’s ePRO Data
When site personnel complete subjects’ e-diaries, bad things happen. Don’t let them happen to your company! A recent FDA Warning Letter questions the validity and integrity of ePRO data captured at a clinical investigator site. What’s a sponsor to do to avoid the same fate? How to Protect Your ePRO Data 1. Select an ePRO… [Read More…]
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