Course Instructor
Rachel Monsef
Consultant to the biopharmaceutical and pharmaceutical industries
Rachel Monsef’s Courses“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 The centerpiece of our discussions will be a new Draft Guidance for Industry published by FDA which expresses the Agency’s current thinking on this crucial subject.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:
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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:
The course will also benefit senior management staff of FDA-regulated companies.
Rachel Monsef
Consultant to the biopharmaceutical and pharmaceutical industries
Rachel Monsef’s CoursesWhen 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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