Description : This 60 minute webinar on a Design Control Audit by the FDA and other bodies will provide an understanding of what a medical OEM should anticipate during an audit during a design control audit. All medical device companies that are in need of examining their design control process should be aware of what to expect.In this webinar, we will discuss practical steps you can follow to make sure your product design control and quality files are ready for an audit. It will also give the attendee guidelines on how to deal with the authorizing bodies.Areas Covered in the Session :Champion/Multi-functional team approach/responsibilityDealing with the FDA and other authorizing bodiesPhase by phase design process check listDesign input/outputDesign verification/validationDesign changesDesign reviewDesign History File (DHF)Due-diligenceGap analysis – data gathering for the design history filesRisk assessmentDesign changes483 warning lettersPlanning to be preparedWho Will Benefit:This webinar will provide valuable assistance and give a process to all medical device and regulated companies that need to prepare for an FDA or authorizing bodies audit in the future. The employees who will benefit include:OEM and CMO quality managersOEM and CMO quality engineersEnd-users responsible for design control and technical filesR&D and product developmentProcess engineers and managersOperations and plant managementValidation engineersRemediation teamsQA, Regulatory AffairsQC and Corporate AuditorsAll team members who contribute to design history files, clinical, verifications/validations, risk management or technical filesConsultantsProject managersSupplier managementProduct transfer engineersAll Contract Manufacturers working in the medical industryPrice Tags:LiveSingle Live : For One Participant$ 249Corporate Live : For Max. 10 Participants$ 899RecordingSingle REC : For One Participant - Unlimited Access for 6 Months$ 299For more information and enquiries contact us atCompliance Trainings5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada  Customer Support : #416-915-4458