Compliance Trainings, Online
2015-02-26
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. Areas Covered in the Session : Champion/Multi-functional team approach/responsibility Dealing with the FDA and other authorizing bodies Phase by phase design process check list Design input/output Design verification/validation Design changes Design review Design History File (DHF) Due-diligence Gap analysis – data gathering for the design history files Risk assessment Design changes 483 warning letters Planning to be prepared Who 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 managers OEM and CMO quality engineers End-users responsible for design control and technical files R&D and product development Process engineers and managers Operations and plant management Validation engineers Remediation teams QA, Regulatory Affairs QC and Corporate Auditors All team members who contribute to design history files, clinical, verifications/validations, risk management or technical files Consultants Project managers Supplier management Product transfer engineers All Contract Manufacturers working in the medical industry Price Tags: Live Single Live : For One Participant $ 249 Corporate Live : For Max. 10 Participants $ 899 Recording Single REC : For One Participant - Unlimited Access for 6 Months $ 299 For more information and enquiries contact us at Compliance Trainings 5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada
Customer Support : #416-915-4458
Email : support@compliancetrainings.com
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