Betty Lane
Founder and President of Be Quality Associates, LLC
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 Society of Women Engineers and the IEEE. Betty has degrees in engineering from Rensselaer Polytechnic Institute (RPI), and an MBA from Northeastern University.
Upcoming Webinar
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Recorded Webinar
Effective Root Cause Analysis: The Key to an Effective Corrective Actions System
In this presentation you will learn the importance of Root Cause Analysis and how it fits into an effective Corrective and Preventive Action system. We will cover where else in your quality management system it can be used, and describe some of the techniques for effective Root Cause Analysis. Examples will be cited to illustrate how each technique works.
Recorded Session Get life time access for one participant with download option!

FDA - Streamlining Your Internal Auditing Process
This webinar will cover creating of a value-added internal auditing program that is compliant to FDA cGMP/ Quality System Regulation and ISO 13485. It will include how to set up and manage the auditing system as well as how to conduct an internal audit and document the results and any nonconformities. It will discuss the value of a good internal auditing program.
Recorded Session Get life time access for one participant with download option!

Medical Device Employee Training - Requirements and Implementation Tips
This webinar will review types of training requirements from the FDA and ISO 13485 for medical device employee. It will discuss techniques for monitoring and documenting training effectiveness.
Recorded Session Get life time access for one participant with download option!

Creating a Risk-based Supplier Management Program
This webinar on supplier controls will provide you the information you need to assure your supplier management program is in compliance with the latest FDA, European and international guidelines requiring a risk-based supplier management program. We will look at how to improve your supplier management system to meet both the FDA and ISO expectation while potentially reducing your cost of compliance.
Recorded Session Get life time access for one participant with download option!

FDA - Streamlining Your Internal Auditing Process
This webinar will cover creating of a value-added internal auditing program that is compliant to FDA cGMP/ Quality System Regulation and ISO 13485. It will include how to set up and manage the auditing system as well as how to conduct an internal audit and document the results and any nonconformities. It will discuss the value of a good internal auditing program.
Recorded Session Get life time access for one participant with download option!

Supplier Quality Agreements - Essential for Suppliers of Outsourced Processes
This webinar on supplier quality assurance (QA) agreement will provide you the information on how to create supplier quality agreements (QA Agreements) with key suppliers and to understand which of your suppliers should have these agreements to meet the expectations of the FDA and ISO 13485 Notified Body auditors. This presentation will also help you prepare for the current expectations of FDA and ISO 13485 notified bodies for demonstrating that you have sufficient control of your key suppliers.
Recorded Session Get life time access for one participant with download option!

Corrective Actions - Current expectation of ISO 13485 and FDA auditors
Earlier, ISO auditors have trained companies on the difference between Corrections (fixing the problem) and Corrective Actions, fixing the root cause of the problem. However, now, although corrections are usually being done, they are done under other portions of ISO 13485, such as control of nonconforming product and customer feedback/ complaints. These often have very little visibility in the Corrective Action system, and generally do not address all containing or correcting quality system issues that are often a major part of a Corrective Actions system. So now ISO auditors, or at least ISO 13485 Notified Body auditors expect companies to document and provide evidence that they are doing containment or correction quickly.
Recorded Session Get life time access for one participant with download option!

Effective Root Cause Analysis : The key to an effective corrective actions system
In this presentation you will learn the importance of root cause analysis and how it fits into an effective corrective and preventive action system. We will cover where else in your quality management system it can be used, and describe some of the techniques for effective root cause analysis. Examples will be cited to illustrate how each technique works.
Recorded Session Get life time access for one participant with download option!

Efficient and Effective FDA and ISO Management Reviews
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.
Recorded Session Get life time access for one participant with download option!

ISO 14971:2012 - Does your current Risk Analysis still comply with your CE Mark requirements
This presentation will provide information on how to review your current risk analysis to make sure you fully comply with the requirements for Risk Analysis under EU Directive 93/42/EEC on Medical Devices and the other European Medical Device directives. The stricter interpretations will be expected during ISO 13485 audits and Technical File and Design Dossier document review starting in 2013. You cannot depend that you can meet these requirements just because your current risk analysis meets ISO14971:2007, unless you are fully aware of the implications of ISO14971:2012.
Recorded Session Get life time access for one participant with download option!

Medical Device Employee Training - Requirements and Implementation Tips
This presentation will provide information and tips on best practices for assuring your employees are properly trained. Improperly or inadequately trained employees lead to both product and process nonconformities.
Recorded Session Get life time access for one participant with download option!

Supplier Quality Agreements – Essential for Suppliers of many outsourced processes
Detailed supplier QA agreements with key suppliers, whether standalone or part of a larger supplier agreement, are becoming essential as more medical device companies are looking to increase their outsourcing.
Recorded Session Get life time access for one participant with download option!

Creating a Risk-based Supplier Management program
This webinar on supplier controls will provide you the information you need to assure your supplier management program is in compliance with the latest European and international guidelines requiring a risk-based supplier management program. We will look at how to improve your supplier management system to meet both the FDA and ISO expectation while using risk information so you may reduce your cost of compliance.
Recorded Session Get life time access for one participant with download option!

How Create a Value-Added cGMP & ISO 13485 Internal Auditing System
Internal audits are required by both the FDA and ISO 13485. This webinar will cover creating of a Risk-based an internal auditing program for compliance to FDA and ISO 13485 internal auditing requirements.
Recorded Session Get life time access for one participant with download option!

ISO 14971:2012 - Does your current Risk Analysis still comply with your CE Mark requirements
This presentation will provide information on how to review your current risk analysis to make sure you fully comply with the requirements for Risk Analysis under EU Directive 93/42/EEC on Medical Devices and the other European Medical Device directives. The stricter interpretations will be expected during ISO 13485 audits and Technical File and Design Dossier document review starting in 2013. You cannot depend that you can meet these requirements just because your current risk analysis meets ISO14971:2007, unless you are fully aware of the implications of ISO14971:2012.
Recorded Session Get life time access for one participant with download option!

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