Avoiding Pharmaceutical and Biopharmaceutical Data Integrity Problems- Brochure

“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 The centerpiece of our discussions will be a new Draft Guidance for Industry published by FDA which expresses the Agency’s current thinking on this crucial subject.