Download
1 / 5
50 likes | 158 Views
This webinar will cover the requirement for management review from FDA cGMP and ISO 13485 and approaches that can make these effective.
E N D
Efficient and Effective FDA and ISO Management Reviews www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Instructor Profile: Betty Lane has over 30 years’ experience in Medical Device quality assurance and regulatory affairs. She is the founder and President of Be Quality Associates, LLC, a consulting company helping small and medium sized medical device and diagnostic companies implement and improve their quality systems. Her work enables companies to manage their business in compliance with FDA and ISO 13485 requirements, as well quality system requirements for other area such as Europe and Canada. Her background in digital systems engineering enables her to facilitate design controls and software validation. Her areas of expertise include training, auditing, supplier management, document and records management, design controls, and software validation.Betty’s training experience includes over 25 years of training on all areas ISO 13485 and FDA cGMP, in companies, and for AAMI, ASQ biomedical division, and ASQ sections. She has taught courses in medical quality and regulatory affairs at Northeastern University, Boston, MA. Betty is active in her local section of the American Society for Quality and is also a member of the Association for the Advancement of Medical Instrumentation (AAMI), The Society of Women Engineers and the IEEE. Betty has degrees in engineering from Rensselaer Polytechnic Institute (RPI), and an MBA from Northeastern University. www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Description: The Webinar will discuss how to make your Management review fit your company and the best ways to get involvement from your senior management. This presentation will cover the requirement for management review from FDA cGMP and ISO 13485 and approaches that can make these effective. Management review should be a key part of keeping your quality management system efficient and effective. It will cover how to get the attention of your senior management as well as practical advice on efficient methods for conducting and documenting management reviews. Why Should you Attend: Are your management reviews effective or do you have trouble getting senior management engaged? Perhaps you are not using an effective approach that fits your company or your management. It is not only important to know what must be covered, but how to present this information to your management team. Learn how to get management's attention to the information being presented and how to make it fit your company culture. Obtain practical information on conducting and documenting management reviews. www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Live Session - How it works • Username and Password will be sent to you 24 hours prior to the webinar • Presentation handouts in pdfformate will be mailed to you • Login to the session using the username and password provided to you • Get answer to your queries through interactive Q&A sessions via chat • Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve • Get certification of attendance. Recorded Session - How it works • A link will be provided to you upon purchase of the recorded session • Please click on the link to access the session • Presentation handouts in pdfformate will be mailed to you • Get certification of attendance. www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Reach us on : www.onlinecompliancepanel.com Our links www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
