Page 1


01:00 PM | 02:30 PM - EST DURATION: 90 MINUTES

Live webinar on "Anticipation and Expectations of a Medical OEM Design Control Audit" DESCRIPTION This 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.

Why Should You Attend? The FDA and other authorizing bodies have become more stringent in their examination of medical OEM procedures, process, and data. Many medical industry companies have not completed all their testing and design reviews before commercializing products properly or brought their mature product lines up to current FDA standards and are not in total compliance. This webinar shows the process to be followed for developing a standard procedure to identify what is expected for design control. For example, companies should be compliant to 21 CFR 820, ISO 13485:2003, ISO 14971:2007, etc. Design History Files and validations need to be up to date to meet current standards. The FDA and other authorizing bodies expect continuous improvement and risk management to be integrated into the company quality system. Old medical devices need to have a risk assessment for each product and updated validations for product and processes. It should describe the risk acceptance criteria as well as roles and responsibilities of each member on the team. 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 Seminar: 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

Live One Dial In - One $189Attendee One Dial In Unlimited attendance (To be arranged in a $249Conference room/Meeting room. Note : Only One Dial In Allowed)

Combo Combo 1 (One Dial In - Unlimited $329attendance + On Demand Recorded Session) Combo 2 (One Dial In - Unlimited $349 attendance + Training CD)

Recorded On Demand ( 90 Days of online $289Streaming access available after the live session ) Play Back Unlimited Views ( Recorded file $319 available for download after the live session ) Get Training CD $359

Gap analysis – data gathering for the design history files Risk assessment Design changes 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: 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 Webinar Includes: Q/A Session with the Expert to ask your question PDF print only copy of PowerPoint slides 90 Minutes Live Presentation Certificate of Attendance

Multiple Location $109 Multiple location 9 - Up to 5 Dial in $499 allowed For any assistance contact us at or call us at 877.782.4696 Or Visit us:-


Anticipation and expectations of a medical oem design control audit  

Compliance2go staff makes a committed effort to bring the best and the ever changing and important laws available to those who need to be ed...

Read more
Read more
Similar to
Popular now
Just for you