2-day In-person Seminar on Verification and Validation – Item, Tools/Procedure, Software program and QMS: Compliance and Governance at Zurich, Switzerland

two-day In-person Seminar on Verification and Validation – Product, Gear/Method, Application and QMS: Compliance and Governance at Zurich, Switzerland
Event on 2014-eleven-06 09:00:00
Course &quotVerification and Validation – Merchandise, Products/Approach, Software program and QMS: Compliance and Governance&quot has been pre-accepted by RAPS as eligible for up to twelve credits towards a participant&#39s RAC recertification on complete completion.

This seminar will provide an overview and in-depth snapshot of the procedure for managing V&V routines affecting merchandise, process, equipment and the QMS. Company personnel accountable for new product growth, regulatory submissions, initiating/overseeing company-broad V&V organizing, utilizing a danger-justified approach and accountable for some of the locations recognized herein, definitely will benefit. Employees who will benefit incorporate all ranges of management and departmental representatives from crucial practical regions and these who wish a greater understanding or a &quotrefresh&quot overview of the V&V approach with merchandise, procedure, computer software and affect on the QMS from start off to finish, with crucial emphasis on regulatory compliance and governance, such as.
The seminar will also expound on numerous locations covering examples, and for clarification and discussion factors with the audience, including but not limited, to the following: layout validation sterilization validation test strategy validation software program validation approach validation style verification and procedure verification DQ, IQ, OQ, PQ and other places linked with the QMS. We will assess V&V protocols how to employ and evaluate sensible equipment/method requirements and specifications. We will overview various documentation and materials that simplify solution, process and products, computer software VT&V and related to the QMS to assure key FDA specifications are not ignored. While thinking about the QMS and 21 CFR Part eleven this seminar will address these essential topics with the audience.

Who Will Benefit:
Regulatory Affairs Management
Regulatory Affairs Expert
Quality Assurance Management
Engineering/Technical Companies
Top quality Assurance or Good quality Management Specialists
Production Management
Manufacturing Engineers
Method Engineers
Application Engineers
Task Managers
Hardware and software program vendors, sales and marketing and advertising

Why you need to attend:
• Understand Verification and Validation, variations and how they operate together
• Develop a &quotWorking Definition&quot of V&V, Qualification, and related terms
• Discuss recent regulatory expectations
• How to document a &quotrisk-based&quot rationale, and use it in a resource-constrained setting
• Determine key &quotmilestones&quot and &quottasks&quot in a project as effectively as discussing audience connected tasks for discussion factors
• Generate Master and Individual Validation Plans
• Learn the key elements of a Solution V&V protocol and expectations with the Summary Report
• Develop Process and/or Manufacturing/Check Gear V&V Files/Protocols
• Sample sizes and their justification
• Learn the essential components of Software program V&V anticipated by the FDA and how to document appropriately and adequately
• QMS Electronic Records and Electronic Signatures per 21 CFR eleven
• Regulatory Requirements for Application Validation and Advantages
• Quality Technique Regulation vs Pre-Market Submissions
• Software demands in specifications
• Verification and Validation approach
• IQ/OQ/PQ in software program V&V and following actions for compliance
• Software improvement as portion of system Style
• Software existence cycle verification
• Software validation right after a adjust
• Validation of Off-the-Shelf Software and Automated Products
• What is Method Validation?
• What are FDA and worldwide needs for Method Validation?
• Process Validation & Tools Qualification
• Examples of successful Method Validation actions
• Where and how does computer software validation integrate into the Validation Strategy?
• Recent examples of FDA Warning Letter cites and other enforcement actions for non-compliant V&V findings…what went incorrect
• Seminar attendees are encouraged to deliver examples of their function from the practical location on the a variety of topics as applicable for group discussion
• Review and examine soreness factors, challenges and answers
• Guidance for Sector, Trends and FDA Inspection & Enforcement Statistics and Trends

Program Outline:

Day 1 – Agenda:
Lecture 1: Regulatory and Compliance Overview/FDA Snapshot on V&V for Producers/Master Validation Organizing
Lecture two: FDA&#39s technique and Chance Management Tools with ISO 14971, ICH and other Guidance/Standards – Item, Method Equipment V&V
Lecture three: Item/Device V&V
Lecture four: Computer software V&V and where and how does software program validation integrate into the Validation Program
Lecture five: Top quality Management Program/21 CFR Element 11 expectations and needs
Lecture 6: Avoid or Reduce Compliance Considerations and Concerns: Q&A/FAQs and evaluation of company documentation

Day 2 – Agenda:
Lecture seven: Computer software V&V documentation
Lecture eight: Software V&V protocols and summary reviews
Lecture 9: Electronic Records and Electronic Signatures (Part 11)
Lecture 10: Program summary discussion
Lecture eleven: Overview of group exercise and hands-on examples and routines demonstrate genuine-world implementation of useful governing rules, equipment and templates and the most current enforcement actions for trending, compliance and governance

David R. Dills is a Regulatory Affairs & Compliance Consultant.
David R. Dills, Regulatory & Compliance Advisor with far more than 24 years of hands-on knowledge and a established track record within the FDA regulated business, has an extensive regulatory and compliance background with Class I/II/III and IVD units, pharmaceutical operations, and manages activities inside the worldwide regulatory and compliance area. He manages high quality, regulatory and compliance projects with several competing priorities obtaining a direct effect on site operations and commercial options and develops approaches for governmental approval to introduce new items to marketplace, provides guidance on regulatory and compliance requirements and prepares/testimonials around the world submissions/dossiers/technical files and addresses worldwide regulatory needs.
Location: Zurich, Switzerland | Date: November 6th & 7th, 2014 | Time: 9 AM to 6PM
Venue: Hilton Zurich Airport
Address: Hohenbuhlstrasse ten, 8152 Opfikon-Glattbrugg, Switzerland

Value: ,595.00
Register now and conserve . (Early Bird)
Till October 17, Early Bird Value: ,595.00
From October 18 to November 04, Normal Cost: ,795.00

Registration Hyperlink: http://bit.ly/VerificationandValidation

Contact Details:
NetZealous LLC,
DBA GlobalCompliancePanel,
161 Mission Falls Lane,
Suite 216, Fremont, CA 94539, USA
Cellphone: 1800 447 9407
Fax: 302-288-6884
Email: support@globalcompliancepanel.com
at Hilton Zurich Airport
Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg
Zurich, Switzerland

Free this week at our point of sale equipment keep:

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Originally posted 2014-10-25 09:05:01. Republished by Old Post Promoter

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