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Avoiding Pharmaceutical and Biopharmaceutical Data Integrity Problems

  January 31, 2019  
CfPA-The Center for Professional Advancement, Online Live
April 8, 2019 at 11:00 a.m.–12:30 p.m. (ET)

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 The centerpiece of our discussions will be a new Draft Guidance for Industry published by FDA which expresses the Agency’s current thinking on this crucial subject. 
Organized by: CfPA-The Center for Professional Advancement
Invited Speakers:
   Rachel Monsef; Consultant to the pharmaceutical industry

Rachel Monsef is a consultant to the biopharmaceutical industry for analytical and quality control. She has 18 years’ experience working with many types of assay for all stages of drug development. She has been responsible for method development, method qualification, method validations, assay transfer, characterization work, and stability studies. Ms. Monsef has 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 Alder Biopharmaceuticals.


Deadline for Abstracts: n/a
Registration: Please click here for registration information.
E-mail: Jmorbit@cfpa.com
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