Pack of 5 Best Selling Webinars on Medical Devices

This webinar package will help you understand the FDA device regulations related to Excel spreadsheets; best practices in preparing metrics and dashboards for management review; how to improve your root cause analysis leading to real and lasting improvements and how to use risk analysis tool on software design. The package will also give insights on FDA guidance on Mobile Medical Apps.
Instructor: Daniel O'Leary, Dev Raheja, David Amor, Susanne Manz
Product ID: PACK70037

CD/Recorded-How It Works:

  • Webinar CD/Recorded will have a series of modules. Our experts have delivered the modules using PowerPoint Presentations
  • Webinar Recording Link or CDs are licensed to be used multiple times at any location with multiple attendants
  • Get unlimited access for Recorded links
  • Free shipment of CDs within 72 hours from the date of purchase
  • Reference materials for Webinar Recording Link/CDs will be mailed to your registered e-mail id

Webinar Topics:

Who will benefit?

  • Quality Engineers
  • Production and Process Engineers
  • Manufacturing Engineers
  • Design Engineers
  • Purchasing Managers
  • Purchasing Agents
  • Supplier Quality Engineers
  • Quality Supervisors
  • Quality Inspectors
  • Quality Managers
  • Quality Auditors
  • Compliance Professionals in Medical Device Companies
  • Individuals preparing data for Management Review
  • CAPA Specialists / Managers
  • Regulatory Affairs Managers
  • R & D Managers and Engineers
  • Software Managers and Engineers
  • Reliability Managers and Engineers
  • Corporate Legal Staff
  • Marketing Managers
  • Service Engineering Managers

Webinars included in the Package:

Excel Spreadsheets and FDA Device Regulations (Duration: 90 Minutes)

This webinar helps you understand the FDA device regulations related to Excel spreadsheets. The webinar begins with Excel methods to help ensure the spreadsheet produces the results you want. It explains the built in Validation tools and how to use them to prevent the user from entering incorrect data. It also explains the use of Formula Auditing to help ensure the calculations are performed correctly. Lastly, the webinar explains the use of Protection to prevent inadvertent and unauthorized changes. To satisfy the broadest interest, the webinar uses Excel 2003 to illustrate the tools. The webinar explains FDA's thinking and shows how to follow the guidance document.

Objectives of the Presentation:

  • Overview of the regulations
  • Excel Validation
  • Using the Excel Convert Function
  • Excel Formula Auditing
  • Excel Protection
  • Track Changes
  • Understanding automated process in ยง820.70(i)
  • Electronic records and Part 11

Instructor Profile:

Daniel O'Leary is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.

Software Reliability and Safety Fundamentals for Medical Devices (Duration: 60 minutes)

Software risk analysis is more difficult than hardware analysis because of thousands of interactions within and with other devices. Intelligence in most devices is a function of several systems working together to produce properties and behavior different than those of components. The disciplines of gathering such intelligence are often missing. This is one reason for increase in device recalls. Most manufacturers have not applied rigors of hardware risk analysis to software designs. The same methods apply to software even though there are differences in software and hardware. Software requirements analysis, PHA, FMEA, FTA, and HAZOP are great tools for software safety.

Objectives of the Presentation:

  • Risk analysis tool on software design
  • Principles of software safety
  • Principles of design for reliability and trustworthiness
  • Writing sound software specifications
  • Safety flaws in the software specifications
  • Writing good safety requirements
  • Writing good reliability requirements
  • Heuristics for designing for trustworthiness
  • Software safety analysis
  • Safety analysis tools
  • Analyzing active safety
  • Safety mitigation methods
  • Designing for software reliability
  • Software Failure Mode and Effects Analysis
  • Fault Tree Analysis for complex mitigations
  • Software qualification testing for safety
  • Software qualification testing for reliability
  • Examples of best practices

Instructor Profile:

Dev Raheja, MS,CSP, author of the forthcoming book Preventing Medical Device Recalls, is an international risk management, patient safety and quality assurance consultant for medical device, healthcare and aerospace industry for over 25 years. Prior to becoming a consultant in 1982 he worked at GE Healthcare as Supervisor of Quality Assurance/Manager of Manufacturing Engineering, at Cooper Industries as Chief Engineer, and at Booz-Allen & Hamilton as Risk Management consultant for variety of industries. His clients include Johnson & Johnson, Siemens Medical Systems, Medtronic, Carl Zeiss, Warner-Lambert, Zimmer Holdings, and DuPont.

Mobile Medical Applications: FDA Guidance and Regulatory Environment (Duration: 90 minutes)

Mobile medical applications using mobile platforms are becoming more ubiquitous in the medical device industry. This webinar will help you understand the FDA guidance on Mobile Medical Apps and learn how the FDA plans to regulate this new hot area of med-tech. Discussion includes, examining "what constitutes an MMA", "what type of MMAs will be regulated" and how to make decisions on your MMA submission.

Objectives of the Presentation:

  • FDA Guidance on Mobile Medical Applications

Instructor Profile:

David Amor is a medical device consultant, having worked with companies such as Boston Scientific, St. Jude Medical and Hospira in helping develop quality management systems and product development infrastructures. A graduate of the Senior Innovation Fellows program at the University of Minnesota Medical Device Center, David was named a Top 40 Under 40 Medical Device Innovator in 2012 and founded MEDgineering, a niche quality consulting firm focusing on FDA remediation and remote work solutions.

Using Metrics to Monitor and Improve Quality Management System (Duration: 90 minutes)

Attend this course to learn the best practices in preparing metrics and dashboards for management review. Without proactive and timely metrics, a medical device company is blind to the health of its quality system and meeting the needs of its stakeholders. This can lead to disaster for the company or, even worse, its customers.

Objectives of the Presentation:

  • How to create a balanced scorecard
  • How to move from lagging to leading indicators
  • How to use indices or profiles to create a more complete picture of performance
  • Lack of transparency in quality/compliance data
  • Use of metrics and dashboards for management review
  • Maturity levels in use of metrics
  • Scalability and hierarchy in metrics

Advanced Root Cause Analysis and CAPA Investigations (Duration: 120 minutes)

CAPA is the corner stone of an effective Quality System for Medical Device companies. However, it is still the number one cause of 483 and Warning Letter Observations. Without an accurate root cause analysis it is impossible to correct and prevent quality and compliance issues. Many companies struggle with inadequate root cause analysis resulting in on-going quality and compliance problems.

Objectives of the Presentation:

  • Build the right team
  • Develop a problem statement
  • Data collection
  • Analysis tools and techniques
  • How to verify your results
  • RCA tool box
  • Real lessons learned
  • Dos and don'ts of RCA
  • Case studies

Instructor Profile:

Susanne Manz is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. She has a BS in Biomedical Engineering and an MBA from the University of NM. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and Certified Quality Auditor (CQA) certification from the American Society for Quality.

Regular Price:$2270.00 Discount Price:$1099.00
You Save: $1171.00(51%)
Get Training CD's

Free shipment within 72hours, from the date of webinar purchase. (For multiple location please contact our customer care team)

Regular Price:$1370.00 Discount Price:$699.00
You Save: $671.00 (48%)
Recorded Session

Get life time access for one participant with download option! (For multiple licenses please contact our customer care team)