Data Integrity – A Global Regulatory Survey

Wednesday, May 24, 2017 - 11:00am to 1:00pm

Not sure if your company is a member of IPEC-Americas? See the Member Companies page.

This webinar will survey the recent regulatory findings concerning data integrity, establish the importance of data integrity to GMP compliance and compare the content of the data integrity guidance from FDA, MHRA, EMA, WHO, and PIC/S.

Ideal for individuals involved with Regulatory Compliance, Quality Assurance, Quality Control, Production who have an appreciation of good documentation practices and GMP records and documents.

Learning Objectives

After attending this webinar, you will be able to:

  • Define data integrity and establish its importance to GMP compliance
  • List and describe recent data integrity issues found by FDA
  • Summarize the content of each regulatory guidance


Irwin B. Silverstein, Ph.D.

Lead Trainer
IPEC-Americas Excipient Learning Lab

Dr. Irwin B. Silverstein.  Irwin is a consultant to IPEC and the excipient industry specializing in quality assurance and regulatory compliance for pharmaceutical excipient ingredients. He also has experience in areas of quality assurance for API, medical device and drug products.

For 17 years he was Corporate Director of Quality Assurance for International Specialty Products (ISP) with responsibility for their excipient, API, and medical device products. Since 1991, he has worked with the International Pharmaceutical Excipients Council (IPEC) developing guidelines for excipient GMP compliance and has represented IPEC at various conferences and at the Food & Drug Administration.

Cancellation Policy


Cancellations for live webinars must be made in writing and can be mailed or e-mailed to:

IPEC-Americas Webinars
3138 10th Street N
Arlington, VA 22201
Suite 500

Registration fees are refundable for attendees registered for individual webinars, if cancellation is received at least five (5) business days prior to the course. Notices of cancellation received 0-4 business days prior to the course will not be provided a refund. If you registered and are unable to attend the webinar, a recording of the webinar will be provided.

No cancellations are available for webcasts (archived recorded webinars). Recordings are available for 21 days after purchase.

Please contact IPEC-Americas Training Coordinator
571-814-3449 or email