Personnel management is the most challenging variable in maintaining current Good Manufacturing Practice (cGMP) across the life cycle of drug manufacture, safety, and supply. A standard operating procedure (SOP) outlines agreed-upon instructions for personnel training and instructions for...
Learning Level: Intermediate - Preparing for full GMP operations requires effective development and deployment of production equipment, procedures, and processes. However, as many experienced leaders can attest, full...
FDA’s recent released Guidance for Industry on Data Integrity and Compliance with Drug CGMP Questions and Answers (CGMPs also known as current Good Manufacturing Practices), clarifies data integrity’s role for drugs and biologics as required in 21 CFR...
This course, the third in a four-part series, has been designed by ISPE and UL EduNeering, in cooperation with the Food and Drug Administration (FDA)/Office of Regulatory Affairs ORA, to assist FDA personnel in...
Knowledge of product development through manufacturing discontinuation has never been more significant in mitigating industry challenges. Learn to address the impact of risk-based approaches and supplier dependability to ensure your company’s...
Another busy day awaits us at the 3rd Annual ISPE-FDA CGMP Conference. Today’s theme is Data Integrity where attendees will hear presentations focused on the implications of data integrity from experts who will present a series of talks throughout the...
Whether you are looking for education on compliance strategies, quality, product development, manufacturing, or regulatory affairs, this conference was planned from an industry point of view. Next month’s conference was planned by Conference Chairs, Joe...
The Third Annual ISPE-FDA CGMP Conference, held in Baltimore, Maryland 2-6 June 2014, opened on Monday, 6 June with welcoming greetings offered by ISPE President and CEO Nancy Berg who introduced co-conference organizers Joe Famulare, vice president,...
If you are going to the ISPE-FDA CGMP Conference, be sure to follow the events on Twitter with hashtag #ISPECGMP. If you are not attending, you can read the session recaps on ISPEAK, which is a great way to stay engaged at your leisure.
Now, on to the...
