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How to Manage Compliance for Cloud-based Life Sciences Systems


April 28, 2020 | 11 am to 12 pm EDT


Sponsored by
AODocs

Webinar Description:

The cloud offers numerous benefits for pharmaceutical, biotech, and medical device companies but while the power of this revolution is recognized for innovation, collaboration, and cost, questions around data security and privacy persist.

Regulatory compliance is one area that drug and device companies must carefully consider before migrating to and adopting cloud-based services, and the lack of clear FDA regulatory guidelines in this shifted landscape remains a significant challenge.

In this webinar we explore what guidance currently exists in this area, what type of solutions exist in the cloud and how they address compliance, and finally we offer best practice guidance to organizations wanting to get value from cloud solutions.

Learning Objectives:

  • What FDA guidelines currently exist for cloud solutions?
  • What type of solutions are life sciences organizations currently using in the cloud?
  • In the absence of appropriate FDA guidelines, what is the best practice for secure, cloud-based solutions?

Speakers:

Rich Lauwers

Information Governance Legal and Regulatory professional

AODocs

Rich Lauwers is an Information Governance Legal and Regulatory professional for AODocs. In his role with AODocs, Rich assists customers and partners in developing strategic solutions for tackling the toughest information management and governance challenges for the Financial Services and BioPharma Industries.

He has been in the information technology and management industry for over 25 years, serving in-house and consultative roles for Fortune 500 and AmLaw 100 firms. Rich is a member of ARMA International and AIIM International, the leading professional associations for the information management industry, and has earned the Certified Information Profession designation, conferred by AIIM. He speaks regularly on a variety of topics in information management at the local and national levels.
https://www.linkedin.com/in/richlauwers/

Rich LauwersKip Wolf

Management Consultant

Tunnell Consulting

Kip brings to Tunnell more than 25 years of experience as a management consultant, during which he has also temporarily held various highly visible leadership positions at some of the world’s top life sciences companies. Kip has temporarily worked inside the life sciences industry on two occasions, both during periods of significant transformational change: first inside Wyeth, pre-Pfizer merger; and, again inside Merck, post-Schering merger. In both cases he led business process management (BPM) groups: at Wyeth, in the manufacturing division; and, at Merck, in the research and development division. In January 2015 Kip joined Tunnell Consulting where he brings his product development program management experience to bear to improve the probability of successful regulatory filing and product launch. He also leads the data integrity practice at Tunnell and consults, teaches, speaks and publishes regularly on topics of data integrity and quality systems. His technical experience includes the fields of quality assurance and regulatory affairs, GMP and IT compliance, technical operations and product supply. His areas of expertise include business transformation, new business development, organizational change leadership and program / project management. Kip holds and maintains various credentials, including the Project Management Professional (PMP) credential and the Program Management Professional (PgMP) credential. He has also completed graduate studies in Drug Development at Temple University, and holds multiple business degrees from Eastern University: an MBA in Management and an undergraduate degree in Management of Information Systems.
https://www.linkedin.com/in/kipwolf/


Cost: No cost!

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