Course Description

Avoiding Pharmaceutical and Biopharmaceutical Data Integrity Problems

Online On Demand

Course Offering 1904904OL2723A
Course ID 2723

In-Person Course

Who Should Attend?
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 Description
“In recent years,” states the Agency, “FDA has increasingly observed CGMP violations involving data integrity during CGMP inspections.” This intensive 90-minute accredited 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 The centerpiece of our discussions will be a new Draft Guidance for Industry published by FDA which expresses the Agency’s current thinking on this crucial subject.

Course Director
Rachel Monsef, Consultant to the biopharmaceutical and pharmaceutical industries

Rachel Monsef is a consultant to the biopharmaceutical and pharmaceutical industry for analytical and quality control. She has 19 years’ experience working with many types of assays for all stages of drug development. She has been responsible for method development, method qualification, method validation, assay transfers, characterization work and stability studies. Ms. Monsef also worked with manufacturing groups to develop and perform assays to support their efforts. She has previously worked for Seattle Genetics and Alder Biopharmaceuticals and is currently consulting for both companies.