OverviewThis Webinar will explain what 21 CFR Part 11 training is, why it is important to c companies and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records will be explained.FDA regulation training is required for companies who want to transition to electronic record system 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. This webinar will show how 21 CFR part 11 considers both. The confusion over the original FDA regulation and its subsequent “selective enforcement” will also be explained.Why Should You AttendCompanies 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 11. After industry complaints the FDA acknowledged that the regulation, as written, would result in nobody attempting to convert to electronic records. But, instead of rewriting the regulation, FDA said it would “selectively enforce” sections of the regulation. This webinar will explain what all this means.Areas Covered in this WebinarCompany certificationRecords coveredUnderstanding the importance of audit trailsOpen/closed system access rulesElectronic signaturesIT security training requirementsLearning ObjectivesHow to establish compliant electronic record systemHow to prevent patient safety compromisesWho Will BenefitEngineering PersonnelQA ProfessionalsIT ProfessionalsQuality AssuranceManagement TeamLevelBeginner