2-Day Virtual Seminar on Verification and Validation – Product, Equipment/Process, Software and QMS (June 27-28, 2022)


DUBLIN, May 25, 2022–(BUSINESS WIRE)–The “2-Day Seminar on Verification and Validation – Product, Equipment/Process, Software and QMS” training has been added to from ResearchAndMarkets.com offer.

The seminar helps participants develop/revise a company’s validation blueprint for key cGMP gaps. Address the US FDA’s newer and stricter regulatory stance.

A major failure is the lack of sufficient or targeted risk-based V&V planning:

  • Start with a Master Validation Plan

  • Assess its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management

  • The individual V&V plan

  • V&V project management

  • “Risk-based” according to ISO 14971, ICH Q9 and/or GAMP/JETT

  • Two key input analysis tools

  • Change control and “draw a line in the sand”

  • Develop meaningful V&V files and protocols for:

  • Quality Management System – 21 CFR 11, Electronic Records/Signatures

  • The roles of the different V&V protocols

  • How to use the equipment/process DQ, IQ, OQ and PQ, or their equivalents,

  • V&V on the basis of SARL resources

  • FDA’s 11-Element Software Matrix Simplifies “”As Product”, “In Product”, “Process & Equipment”, et al, VT&V Software

  • Ensure key US FDA requirements and comparable EU MDD/ISO requirements are not overlooked

  • The QMS and 21 CFR Part 11, “Electronic Records/Signatures” V&V

  • Practical examples and activities show real-world implementation of helpful principles, tools and models

OBJECTIVES OF THE SEMINAR

  • Understand verification and validation, the differences and how they work together

  • Develop a “working definition” of V&V, qualification and related terms

  • Discuss recent regulatory expectations

  • How to document a “risk-based” rationale and use it in a resource-constrained setting

  • Determine the key “milestones” and “tasks” of a project; device sample provided

  • Locate and document key subject “entries”

  • Compile master and individual “generic” validation plans

  • Learn the key element of a product V&V file/protocol

  • How to develop V&V files/protocols of process and/or production/test equipment

  • Basic test case/script building

  • Sample sizes and their rationale

  • Learn the 11 key elements of V&V software expected by the FDA and how to document

  • Learn how to compile QMS electronic records and V&V electronic signatures according to 21 CFR 11 and associated CGMPs

Main topics covered:

DAY 1

  • V&V planning; The validation master plan; The individual validation plan

  • “Risk-based” – Evaluate its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management – Narrative file, Hazard analysis, FTA, 3 FMEA (Design, Process, Use[r], and a possible 4th software); also GAMP/JETT approaches

  • V&V Project Management – “Milestones” and “Tasks”

  • Two key input analysis tools: the process map/flowchart and the cause and effect diagram (templates provided)

  • Change control and “draw a line in the sand”

  • Elements of a V&V file/protocol:

DAY 2

  • Develop and use meaningful V&V files and protocols to:

    • Some products

    • Process

    • production equipment

    • Monitoring and test equipment

    • Software

    • Quality Management System – 21 CFR 11, Electronic Records/Signature

  • FDA’s 11-Element Software Matrix Simplifies V&V Software “”As Product”, “In Product”, Process, and Equipment – What They Mean, How to Find, and How to Document

  • QMS, ERP and 21 CFR Part 11 V&V – “Cloud” issues; “White box” and “black box” tests; Basic test case development

  • V&V, Senior Management/Intellectual Property and Limited Liability Company Resources

  • US FDA audit issues and “responsible” documentation

  • Interactive discussions and Q&A session

The course is suitable for:

  • Regulatory Affairs Departments

  • Quality Assurance Departments

  • Quality control departments

  • IT/IS departments

  • Research and Development Departments

  • Production departments

  • Manufacturing departments

  • Engineering departments

  • Process engineers

  • Software engineers

  • Project managers

  • Hardware and software vendors, sales and marketing

For more information on this training, visit https://www.researchandmarkets.com/r/iqh5gn

About ResearchAndMarkets.com

ResearchAndMarkets.com is the world’s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, top companies, new products and the latest trends.

See the source version on businesswire.com: https://www.businesswire.com/news/home/20220525005780/en/

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ResearchAndMarkets.com
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[email protected]

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