Tag Archives: Axendia

22Mar/19
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FDA Shares Quality Considerations for Continuous Manufacturing

A Straight from the Source Webinar

 FDA is committed to supporting and enabling pharmaceutical innovation and modernization. The Agency recognizes that continuous manufacturing is an emerging technology that can enable pharmaceutical modernization and deliver potential benefits to both industry and patients.

Join FDA’s Thomas O’Connor, Ph.D. and Axendia’s Daniel R. Matlis for a live webinar.

Date and Time:  April 17th at 11:00 AM ET. 

We will discuss FDA’s perspective on pharmaceutical innovation and modernization including:

  • FDA’s draft guidance on Quality Considerations for Continuous Manufacturing
  • How continuous manufacturing can improve pharmaceutical manufacturing
  • Support of enhanced development approaches such as quality by design (QbD), process analytical technology (PAT) and models
  • Insights from dialogue with sponsors through the Emerging Technology Program, externally funded and internal research
  • Experiences from review and approval of five drug applications utilizing continuous manufacturing to date

Meet Your Trusted Sources

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Scheduling Conflict? Register and receive a link to view the on-demand recording after the event.

Participation is Limited!

register

21Mar/19
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Unstructured Tools Are Not A Good Fit For A Structured Process

Jama Software Brief

By: Sandra K. Rodriguez, Market Analyst

The Jama Software executive team recently briefed Axendia on its product development platform that is comprised of its flagship product – Jama Connect – and newly developed Jama Analyze.  Headquartered in Portland, Oregon, the company aims to help medical device companies modernize, digitize and transform an increasingly complex product development process.

Jama Connect allows companies to focus on quality from the standpoint of requirements, risk management and testing and brings it all together in a modern, collaborative and centralized way.  “Customers are coming to us to really drive innovation and quality in an accelerated time frame as they face competitive pressures,” said Joel Hutchinson, Product Manager at Jama Software.

Companies ranging from Merck to Boston-Scientific are managing requirements, risk, test and project volatility through the use of Jama Connect.

Please register to receive your complimentary copy of this Brief.

 

19Mar/19
Sparta CSA eBook Cover

eBook: Goodbye Computer System Validation…

Hello Computer System Assurance (CSA)!

By: Daniel R. Matlis, President and Ellyn McMullin, Research Associate

FDA supports and encourages the use of automation systems and digital technologies throughout the product lifecycle to improve patient outcomes and reduce the risk to patients. It is a common misconception that extensive testing and documentation is required to demonstrate the validation of computer software used in automation.

The FDA, recognizing industries CSV challenges, has announced new guidance on “Computer Software Assurance for Manufacturing, Operations and Quality System Software.” This guidance is on the Agency’s “A-list” and is planned for release in FY 2019.

The content is this eBook represents Axendia’s analysis and opinions on “Computer Software Assurance for Manufacturing, Operations, and Quality System Software” based on the following trusted sources:

  • Axendia’s interaction with FDA representatives on this topic
  • Content and material sourced from FDA
  • First-hand experience from Axendia’s clients on the implementation of CSA

Register to receive this eBook, sponsored by Sparta Systems, and learn:

  • Why Critical Thinking is the Foundation of CSA
  • How to Implement a Risk-Based Approach to CSA
  • The Objectives of CSA
  • What the CSA Landscape Looks Like
  • Acceptable Levels of Assurance

Webinar also now available on-demand:  Understanding the FDA’s New Approach to Computer System Validation.

 

 

12Mar/19
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eBook: CSA – A Streamlined Approach to Validation

Computer System Assurance in Support of Manufacturing 4.0

By: Daniel R. Matlis, President

Computer System Validation (CSA) is a streamlined approach to validation that supports Manufacturing 4.0 in the Life-Sciences.   Medical Device Executives believe this new approach will result in a 30% to 50% reduction in time and cost, and will increase and accelerate improvements and innovation.

This eBook includes success stories and first-hand examples by:

Axendia_Validation_P10-copyrightedFrancisco (Cisco) Vicenty, Program Manager – CfQ, US FDA

Jason Spiegler, Sr. Director, Industry Portfolio Development, Siemens PLM

Damien McPhillips, Sr. Quality Manager – Global Software and Digital Health, Boston Scientific

Ray Murphy, Principal Software Quality Engineer, Boston Scientific

April Francis, Director Global IT Quality and Compliance, Medtronic

Frank Melendandri, Sr., Manager, Quality Assurance, Zoll Lifevest

 

This paradigm shift has had an enormous impact on the industry.  Backed by the FDA, a new era of computer system validation is here. According to Cisco Vicenty, CfQ Program Manager at FDA: “All the recommendations that the Non-Product CSV Guidance is highlighting, is within scope of the FDA’s QSRs and is compliant.”
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05Mar/19
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Disruption is on the Radar! You Must Plot a Course for Success.

Webinar Available On-Demand

Disruption is on the radar! Life-Science executives must plot a course for success.  That was the theme of our “Straight from the Source” webinar featuring Axendia’s President, Daniel R. Matlis and Sandra K. Rodriguez, Market Analyst, on February 20th.

Since 2005, Industry stakeholders and regulators have relied on Axendia for trusted advice on Business, Regulatory and Technology issues and trends.  Due to our track-record of accurately predicting Life-Science trends, our clients often ask us to forecast what’s on the horizon.

To answer this question, we developed a Life Science radar to communicate our focus areas in the markets we service, as well as share when we predict these trends will become mainstream. Continue reading