iSpeak Blog

What to Expect at the ISPE-FDA CGMP Conference!


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 pharmaceutical quality systems are robust, reliable and secure by attending the ISPE/FDA  3rd Annual CGMP conference this June in Baltimore, MD, where more than 20 regulators will be present to discuss latest compliance trends and clarification of expectations.


FDA and regulators such as Janet Woodcock, MD and Ilisa Bernstein, PharmD, JD and Industry experts, Mary Oats, PhD and David Smith, will be available through Q&A, presentations, panel discussions and breakfast sessions to assist your company in making regulation uncertainty a thing of the past. Monday, 2 June brings manufacturing, science and quality to the next level with the Quality Systems: Lifecycle from Development to Discontinuation session.

You’ll gain knowledge on implementing and measuring a culture of quality as well as hear presentations on a variety of topics in metrics and process validation. Breakout sessions, Challenges of Development – Anticipating Your Process will prepare you for proactive scale-up and tech transfer practices, explain the role of PAT in Quality/Tech Transfer, increase your knowledge management beyond ICH Q10, expose you to real-world current FDA experiences, “lessons learned” and case studies. The session Maintaining a State of Control shows the attendee how GMPs work together from device and drug product and applications in assessing uniformity.

On Tuesday, the participants will be exposed to a variety of Hot Topic discussions in Data Integrity such as approaches to assuring reliable supply from India; updates on the ISPE stratified sampling white paper and legal aspects of data integrity among others. The final day, Wednesday, brings discussions on Drug Shortages including a report on the ISPE Drug Shortages Taskforce on emerging strategies for preventing and mitigating shortages, updates from Europe and an overview from the EMA. The Industry-regulatory roundtable gives you the opportunity to have an up-close and personal opportunity to hear what regulators are saying. And most importantly, don’t forget your business cards. The ISPE/FDA CGMP conference offers networking like no other. Continue conversations with colleagues and presenters from around the world during the welcome reception, structured discussion groups and networking breaks. Have your registered yet? Don’t miss out, early registration ends 9 May. Register today! Tell us what you’re looking forward to learning in Baltimore!