OverviewThis webinar is a comparative look at FDA & EU regulations to help attendees understand the FDA and EU inspection process and how to prepare for both of them. Attendees will learn the best practices to respond to Form 483 citations, Warning Letters and EU inspection findings.Why Should You AttendFDA regulations training and EU regulations and standards apply for pharmaceuticals, biologics and medical devices. Failure to conform to these good clinical practice training may result in concerns about quality and integrity. Inspections are critical to the success of business on several levels. Therefore, being appropriately prepared and management of the inspection and audit process are critical activities. The consequences if a company does not pass an inspection are time consuming, delayed product approvals, and could lead to civil or even criminal litigation by the FDA and EU inspection agencies. This webinar has been specifically designed to help attendees prepare for FDA and EU inspection. It will provide a background and understanding of the role played by the regulatory inspectors, and the administrative and enforcement powers. Attendees will be taken through the key stages of FDA and EU inspection processes and understands the various types of inspections that can be carried out.Areas Covered in this WebinarDifferences between FDA and EU inspections including the FDA and EU joint inspection programmerHow to prepare for EMA and FDA audit trainingHow to plan for an audit or inspection using checklists/ FDA/EMEA inspection guidelinesTips for employees before the inspectTips on proper responses to prepare for audit/inspection interviewsSetting up a triage to ensure that required documents are availableHow to interact with the inspectors—DOs and DON’TsHow to reply to inspection reports, form 483 fda’s and EU inspection findingPost inspection actions – implementing appropriate CAPAs in response to audit findingsLearning ObjectivesWhat to expect during an FDA/EU inspection How to be prepared – with special focus on GCP inspectionsWho Will BenefitQuality Assurance Managers and AuditorsRegulatory Affairs PersonnelDocument Management ProfessionalsOther Professionals who want to know more about inspection guidelinesLevelBeginner