FDA QS Software Validation Training Course – Boston – Jun 2-4, 2020

FDA Quality System (QS) Software Validation Public Training Course DATES:  June 2-4, 2020

62304 public training course
Brian Pate of SoftwareCPR at a recent course

COST: 3 Full Days for $2,595.00 (Registration closes 5/2/2020)
Volume Discount:  $450 off for 4 or more students from same company

Register Now:  https://events.eventzilla.net/e/2020-softwarecpr-quality-system-software-validation-training-course–boston-ma-2138751888

This course covers software validation expectations for the whole range of Quality System Software (QSS) including computer systems validation, production/manufacturing automation and control software, quality system process software, and engineering tools. As always, our approach is to show the flexibility of the regulations and help students understand the intent of the regulations to achieve validation methods that are efficient and effective … and how to correctly articulate alignment with regulations and standards. We emphasize the critical thinking concept and discuss foundational methods such as process risk analysis as a way to scale and focus the QSS software validation tasks and documentation.

Key topics:

  • Regulatory landscape Software Validation Planning Off-the-shelf
  • SOUP (open source, commercial)
  • Legacy Software
  • Intended Use / Requirements
  • Process risk analysis
  • Differing validation approaches based on risk
  • Architecture and detailed design
  • Implementation, Coding, Unit verification
  • Integration and integration testing
  • Problem Issue and Defect Management
  • Usability Evaluations
  • Configuration Management
  • Development process rigor
  • Maintenance phase (Change control, Retirement)
  • Document Hierarchies and Traceability
  • Electronic records & Signatures / 21 CFR Part 11 Cybersecurity

This 3 day course will be taught by Brian Pate of SoftwareCPR and John F. Murray, Jr.

Full credentials on our website: https://www.softwarecpr.com

Who Should Attend this FDA QS Software Validation Training Course?

Quality Assurance and Regulatory Affairs professionals. This course will provide a clear understanding of requirements versus areas of flexibility and provide checklists and questions to use for gap analysis, auditing, and vendor and OEM qualification and management.
Manufacturing, IT Managers and staff, Production/process and control, Product Owners, Scrum Masters/Coaches, software development managers/engineers, and test engineers. This course provides examples, checklists, and partial templates as well as improving articulation and defense of your approaches to regulatory bodies, internal quality assurance, and regulatory affairs departments.

Training Course Location

Boston University

Training will be held on the 18th Floor of the “10 Buick St” building on the campus of Boston University in Boston, MA  USA.  There are nearby hotels within walking distance or you might consider BU Housing (contact them directly http://www.bu.edu/housing/).

Course start 9:00 am ET each day and ends at 5:00 pm PT. Lunch is provided.  Course will end by 4:00 pm ET on 3rd day.

Would you (or one of your colleagues) like to know more about the course? You can get more information on our courses at this link:  https://www.softwarecpr.com/training/

Are there opportunities for discounts? Yes! We have a special $450 per person discount when you register 4 or more students from the same company.  Other discounts may be available … please email training@softwarecpr.com to learn more.

If you prefer to be invoiced for the registration, please email training@softwarecpr.com and we will get the registration information and other info needed.

More info?

About the author

Brian Pate helps medical device companies achieve efficient and FDA regulatory compliant product development to produce higher quality and clinically valued software. He began his career in clinical research in 1985 with the Department of Anesthesiology at UAB developing closed-loop control systems for the automated delivery of gases and control. In 1990, he made the switch from university research to the medical device industry designing control systems, communication interfaces, user interface, and other software for real-time embedded systems and clinical information systems, working for medical device companies including Johnson & Johnson, Baxter Healthcare, and GE Medical. Today, he is a Partner and the General Manager of Crisis Prevention and Recovery LLC (dba SoftwareCPR®), a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software. He has taught the AAMI/FDA course on Software Regulation to FDA Reviewers at FDA and is currently the lead faculty for the public version of that course taught annually along with FDA staff. Brian served on the AAMI/FDA TIR working group that created AAMI TIR32 Guidance on the application of ISO 14971 to Software (later superseded by IEC 80002-1). He later served on the original AAMI/FDA working group that created the AAMI TIR45-2012 TIR Guidance on the use of Agile practices in the development of medical device software and is currently the co-chair leading the creation of the 2nd edition of TIR45. He has served as faculty for all offerings of the AAMI/FDA Compliant Use of Agile Methods public course. Brian also served as an instructor for the AAMI Design Controls course. He is also a member of the Underwriters’ Laboratories Standards Technical Panel 5500, Remote Software Updates. He now serves as a member of the AAMI Software Committee.

Upcoming Training

QSS Software Validation
Planned Instructors:  Brian Pate, John Murray
Location: Boston, MA, USA
Dates:  June 2-4, 2020
Registration Link

Receive $300 discount with Premium-Individual subscription purchase (or $333 per person for Premium-Company subscription)! 

Multi-Student Discounts as well!

Email training@softwarecpr.com
to receive discount

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