Training Doyens

Carolyn Troiano Carolyn Troiano FDA Compliance Consultant Years of Experience:  35+ years Areas of Expertise:  Strategic Planning, Project Management, FDA Regulatory Compliance, Organizational Development & Effectiveness, and Change Leadership & Management Carolyn Troiano  has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health and other FDA-regulated industries. She is currently managing a large, complex data migration, analytics and reporting program at a major financial institution. During her career, Carolyn worked directly, or as a consultant, for many top-tier pharmaceutical companies in the US and Europe. She was responsible for computer system validation across all GxP functions at a major pharmaceutical company. Carolyn developed validation programs and strategies back in the mid-1980s, when FDA guidelines were first issued. She was an industry reviewer for 21 CFR Part 11, the...

OVERVIEW FDA regulated companies want to transition to electronic records for economy and efficiency. FDA, because of its concern for patient safety, wants to prevent electronic records from being compromised with possible resulting harm to the patient. FDA has set up regulations that address both data security and patient safety. We will show how  FDA 21 CFR Part 11  compliance checklist considers both. The confusion over the original FDA regulation and its subsequent  “selective enforcement ” will be explained. FDA requirements for electronic record and signature validation will be explained. The requirements are composed of technical and procedural aspects. Open, closed and hybrid (paper and electronic) systems will be explained. WHY SHOULD YOU ATTEND Companies want to transition to electronic records but are afraid of compromising their quality system and receiving 483’s at their next inspection. Part of this fear originates from confusion. FDA origina...

OVERVIEW FDA regulated companies want to transition to electronic records for economy and efficiency. FDA, because of its concern for patient safety, wants to prevent electronic records from being compromised with possible resulting harm to the patient. FDA has set up regulations that address both data security and patient safety. We will show how 21 CFR part 11 considers both. The confusion over the original FDA regulation and its subsequent “selective enforcement” will be explained. FDA requirements for 21 CFR Part 11 validation will be explained. The requirements are composed of technical and procedural aspects. Open, Closed and  H ybrid  (paper and electronic) systems will be explained. WHY SHOULD YOU ATTEND Companies want to transition to electronic records but are afraid of compromising their quality system and receiving 483’s at their next inspection. Part of this fear originates from confusion. FDA originally published a rather severe 21 CFR Part ...