Software Validation for the New FDA Inspections


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Software Validation for the New FDA Inspections

  1. 1. Net Zealous 2-day In-person Seminar 2013 Software Validation for the New FDA Inspections by David Nettleton Location: San Diego | September 19th & 20th, 2013 | 9 AM to 6 PM PDT About GlobalCompliancePanel: GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost-effective while being convenient. GlobalCompliancePanel imparts knowledge of best practices across a broad range of user-friendly mediums such as webinars, seminars, conferences and tailored, individualized consulting. These help organizations and professionals implement compliance programs that meet regulatory demands and put business processes in place. Through our trainings, we bring together the regulators or experts on regulation on the one hand, with the community that needs to learn or be aware of those regulations, on the other. Our services benefit the Medical Devices, Pharmaceutical, Bio Technology, Food Safety, Financial Accounting Standards, and IT Control & PCI Industries. Our clientele includes companies such as J&J, Pfizer, Sanofi Aventis, Pall Corp, Abbott, Merck, Bayer, and Roche, some of which are Fortune 500 companies. Professionals who undergo trainings from GlobalCompliancePanel exhibit a vastly improved quality of life in which there is increased productivity and professional growth. Some 30,000 professionals have gained from more than 500 training courses we have conducted till now. All rights are reserved © GlobalCompliancePanel.
  2. 2. 2-day In-person Seminar 2013 David Nettleton FDA Compliance Specialist, About Speaker: David Nettleton is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. His latest book is Risk Based Software Validation - Ten easy Steps. It relates to the development, purchase, installation, operation and maintenance of computerized systems used in regulated applications. He specializes in performing gap analysis, remediation plans, SOP development, vendor audits, training, and project management. He has completed more than 225 mission critical software validation projects. Venue Date and Venue: September 19th & 20th, 2013 at San Diego Doubletree Hotel San Diego Downtown 1646 Front Street, San Diego, California, 92101, USA from 9 am to 6 pm PDT at Doubletree Hotel San Diego Downtown All rights are reserved © GlobalCompliancePanel.
  3. 3. 2-day In-person Seminar 2013 Overview: This course will teach you how to reduce software validation costs by as much as two thirds. It details all the requirements for 21 CFR Part 11 and HIPAA that relate to SOPs, software features, and risk-based validation.  The course is highly interactive, using real life examples and proven techniques.  You will learn how to use electronic records and electronic signatures to maximize productivity.  This course will teach you how to prepare for an audit and is intended for IT, QA, laboratory, clinical, and manufacturing staff, as well as software vendors.   Seminar Content: Day 1 - Agenda Lecture 1: Introduction to the FDA  Day 2 - Agenda Lecture 6: Ten-Step Process for COTS Computer System Validation How the regulations help your company to be successful  Conference Timings: 9am to 6 pm PDT Which data and systems are subject to Part 11.  Learn which documents the FDA expects to audit.  How to use the risk-based validation approach to lower costs.  How to link requirements, specifications, risk management, and testing.  Document a computer system validation project using easy to understand fill-in-the-blank templates.  Based on: "Risk-Based Software Validation - Ten Easy Steps" (Davis Horwood International and PDA, 2006). Lecture 2: 21 CFR Part 11 - Compliance for Electronic Records and Signatures  What Part 11 means to you, not just what it says in the regulation.  Avoid 483 and Warning Letters.  Explore the three primary areas of Part 11 compliance: SOPs, software product features, and validation documentation.  Ensure data integrity, security, and protect intellectual property.  Understand the current computer system industry standards for security, data transfer, and audit trails.  Electronic signatures, digital pens, and biometric signatures.  SOPs required for the IT infrastructure.  Product features to look for when purchasing COTS software. Lecture 7: How to Write Requirements and Specications  Workshop for writing requirements and then expanding them for specifications Lecture 8: How to Conduct a Hazard Analysis/Risk Assessment-Exercise  Step-by-step instructions for performing and documenting a risk assessment, and how to use the results to reduce validation documentation. Lecture 9: Software Testing Reduce validation resources by using easy to understand fill-in-the-blank validation documents.  Reduce testing by writing test cases that trace to elements of risk management. Lecture 3: HIPAA Compliance for Electronic Records  How to write efficient test cases   How Part 11 and HIPAA interrelate  What are the additional requirements for patient data Lecture 4: The Five Keys to COTS Computer System Validation  Lecture 10: System Change Control  How to manage a validated system with minimal documentation Lecture 11: Cost Reduction Without Increasing Regulatory or Business Risk The Who, What, Where, When, and Why of CSV  How to save money  How to increase quality  How to increase compliance with less documentation Lecture 5: The Validation Team  How to select team members  How to facilitate a validation project Lecture 12: Q & A All rights are reserved © GlobalCompliancePanel.
  4. 4. 2-day In-person Seminar 2013 What you get: Pricing List: 1. 2. 3. 4. 5. 6. 7. 8. Learning Objectives Participation certificates Interactive sessions with the US expert Post event email assistance to your queries. Special price on future purchase of web based trainings. Special price on future consulting or expertise services. Special price on future seminars by GlobalCompliancePanel. Seminar Kit – includes presentation handout, ID card, brochure, trainings catalog, notepad and pen. 9. Networking with industry's top notch professionals Price for One Delegate pass Price: $1,295.00 September 19th & 20th, 2013 ( Thursday & Friday) Register now and save $200. (Early Bird) Until July 31, Early Bird Price: $1,295.00 From August 01 to September 17, Regular Price: Price: $1,495.00 **Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar. Companies that will benefit:  Drug and Biologics Companies  PAT Teams  Process Development Professionals who will benefit: Payment Options:    IT Credit Card: Use the Link to make Payment by Visa/Master/American Express card click on the register now link Check: Kindly make the check payable to NetZealous DBA GlobalCompliancePanel and mailed to 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA  QA  QC  PO: Please drop an email to or call the our toll free 1800 447 9407 for the invoice and you may fax the PO to 302 288 6884  Wire Transfer: Please drop an email to or call our toll free 1800 447 9407 for the wire transfer information  Laboratory staff  Managers  Regulatory Affairs  GMP, GCP, GLP professionals Contact Information: Event Coordinator Toll free: 1800 447 9407 Fax: 302 288 6884 Email: NetZealous LLC, DBA GlobalCompliancePanel, 161 Mission Falls Lane, Kindly get in touch with us for any help or information. Look forward to meeting you at the seminar Team GlobalCompliancePanel Suite 216, Fremont, CA 94539, USA All rights are reserved © GlobalCompliancePanel.