The need for a Data Integrity process throughout the lifecycle
The requirement for a data governance system
How to meet the requirements of 21 CFR Part 11 electronic records and signatures, including the FDA interpretation in the Scope and Application Guidance
How to meet international regulatory requirements for electronic records and signatures
How to apply the current industry risk-based good practice approach to compliant electronic records and signatures
The operation phase of the GAMP® lifecycle
How new technologies such as cloud computing and mobile applications can impact Data Integrity
The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) has recently announced the adoption of the revised guideline
The outlook for the biopharmaceutical market is promising, with expectations that the market will double in the next 10 years, resulting in new therapies and advances in biopharmaceutical manufacturing. This doesn't sound like much at first, but if you consider how the market has developed over the last 20 years, a doubling in the next 10 years is very significant.
The following blog post was provided by Peyton Myers, an undergraduate student at Appalachian State University. Myers attended the 2023 ISPE Annual Meeting & Expo in Las Vegas as an ISPE Foundation Professional Development Grant recipient.