Current Good Manufacturing Practice (cGMP)

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...

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...

Welcome to the 3rd Annual ISPE-FDA CGMP Conference. The FDA and Industry experts will provide you with the insights you need to ensure quality both day-to-day and strategically, over the product lifecycle. No other event drives critical conversations...

Jenn Walsh, Associate Director Manufacturing Technology, Bristol Myers Squibb moderated a night session on process validation. Dafni Bika, PhD, VP, Global Manufacturing and Supply, Bristol Myers Squibb, discussed the implementation status of 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...

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...

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...

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,...