Participants will benefit from understanding the current international regulations for 1-Stage Process Validation as well as realizing the significant business benefits that come from taking a science and risk-based approach.Current Regulatory Expectations (FDA Stage 1)· Clarify similarities and differences between EU and US expectations· Establish a three-stage, science and risk-based, lifecycle process validation programmed.· impact […]
There are two parts to this webinar: 1) CSA and data integrity GPG DI alignment; and, (2) Insert more data integrity so we don’t bore people with CSAHear directly from the source, FDA – Industry CSA Team & Colleagues in a Panel setting discussing the upcoming ISPE GAMP Good Practice Guide (GPG) Data Integrity (DI) […]
With the release of Data Integrity guidelines from FDA, MHRA, EMA and other regulatory bodies across the globe, data integrity compliance received limelight across the industry since 2015. Looking at the trend of increase in warning letters on Data Integrity non-compliance, the industry jumped immediately into Remediation exercises to achieve compliance with the Data Integrity […]
Spreadsheets are often a weak link in the data integrity compliance chain. If left uncontrolled, they present a major data integrity risk to the organization. In the first part of this webinar, we will review the reasons for their popularity as well as interesting anecdotes about spreadsheet errors. We will understand common issues and problems, by […]
You Can’t Distance From Quality Pharmaceutical manufacturing companies are essential businesses in the current global environment of pandemic response; the products supplied are critical to the care and wellbeing of patients around the world. Continuing to operate in a controlled manner, following their Quality Systems, and producing safe and effective products are a significant challenge […]
