Avoiding Pharmaceutical and BioPharmaceutical Data Integrity Problems

Focus on FDA Data Integrity Guidance

Duration: 90 Minutes
Course Instructor

Rachel Monsef

$ 295
Discounts: We offer a 10% group discount when you register 2 or more attendees (up to 10). Contact us for groups over 10.

Course description

View Course Outline

“In recent years,” states the Agency, “FDA has increasingly observed CGMP violations involving data integrity during CGMP inspections.” While a few of these situations may actually involve intentional fraud, others may occur where simply inadequate controls have been put into place to prevent data manipulation. Whether intentional or not, FDA views these situations as unacceptable.

This intensive online training course focuses on how you can look for, assess, and correct possible Data Integrity issues at your firm, and demonstrate to FDA that your CGMP data are ALCOA (attributable, legible, contemporaneously recorded, original or a true copy, accurate). The centerpiece of our discussions will be a new Draft Guidance for Industry published by FDA which expresses the Agency’s current thinking on this crucial subject.

Upon completion of this course, you will be able to:

  • Explain why data integrity is of crucial importance to your firm and to the FDA.
  • Spot potential data integrity issues at your firm.
  • List some essential activities to perform and other activities to avoid that help prevent data integrity issues during FDA inspections of your electronic and paper CGMP records and documents.
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This timely online training course will benefit professionals in the following FDA-regulated industries: Pharmaceuticals, Biopharmaceuticals, Vaccines, Cellular and Tissue Therapies and other Biologics, PET Drugs.

This online training course will be of benefit to all persons whose span of responsibility includes compliance with the U.S. Food and Drug Administration’s (FDA’s) Current Good Manufacturing and Good Tissue Practice Regulations (CGMPs and CGTPs) including, but not limited to, scientists and other professionals in:

  • Quality Assurance
  • Quality Control
  • Regulatory Affairs
  • Compliance
  • Development
  • Manufacturing and Production
  • Auditing

The course will also benefit senior management staff of FDA-regulated companies.

Course Instructor


Rachel Monsef

Consultant to the biopharmaceutical and pharmaceutical industries

Rachel Monsef’s Courses


Team Training

When you need on-site attention, we’re not just here to help, we’re there to help—right by your side.

Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.

In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.

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