Validation and 21 CFR 11 Compliance of Computer Systems: Intermediate to Advanced

Transcription

1 Global CompliancePanel Knowledge, a Way Forward 2-day In-person Seminar: Validation and 21 CFR 11 Compliance of Computer Systems: Intermediate to Advanced San Diego, CA July 14th & 15th, :00 AM to 6:00 PM Price (Without Stay) Price: $1, (Seminar for One Delegate) (With Stay) Price: $1, (Seminar for One Delegate) Register now and save $200. (Early Bird) Angela Bazigos CEO, Touchstone Technologies Silicon Valley **Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar. Angela Bazigos, is the CEO of Touchstone Technologies Silicon Valley, Inc. "Your Passport to Compliance". She has 30 years of experience in the Lifesciences industry spanning Project Management, Quality Assurance and Regulatory Affairs and has a patent aimed at speeding up Software Compliance. Ms Bazigos is a member of the SQA CVIC (Society of Quality Assurance Computer Validation Initiative Committee), ASQ, DIA and RAPS and consults to investment groups on Lifesciences investments Overview: Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, unless one knows how to implement CSV, it is often very hard to detect the Seminar Pricing Includes (With Stay) Google Nexus 7 Tablet 2 Days Stay Pick-up and Drop Facility (Nearest Airport) Break-Fast and Lunch High Tea Pack of 3 Webinars will be provided which has been done in the past on similar subject requirement for CSV, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the FDA has stepped up 21 CFR 11 inspections that include CSV. This course will build on the Validation and 21 CFR 11 Compliance Basic Course, to give hands on experience on executing on the computer systems validation of a system, and to discuss related activities such as Validation Master Plan, Infrastructure Qualification, Project Management

2 Global CompliancePanel 2-day In-person Seminar: Validation and 21 CFR 11 Compliance of Computer Systems: Intermediate to Advanced Why should you attend: VP of IT Director of IT Quality Managers Project Managers (for CSV / IT) Validation Specialists Database Administrators System Administrators Directors / Senior Directors of Discovery Industries: Pharmaceuticals Biotech Medical Device Radiological Health Blood Products Companion Animals Food Cosmetics Tobacco AGENDA: Day One Day Two Lecture 1: Introduction / Background Introductions / Participants' Understanding Participants' Objectives for the Course (Please come prepared to discuss) Lecture 2: Requirements at a High Level Types of Requirements Difference between User Requirements & Functional Requirements Lecture 3: Detailed Requirements Study Gathering Requirements Entity Relationship Diagram Process Decomposition Risk Assessment for Requirements Exercise on how to create Requirements Lecture 4: Design Design Specifications Software Configuration and Build Exercise on how to create Design Specifications Lecture 5: CSV Detailed Study (Cont'd) Traceability Matrix Verification and Testing Exercise Creating Validation Scripts Exercise Creating Traceability Matrix Lecture 6: Other Documents Validation Plan Test Protocols Test Reports Validation Report Validation Registry Lecture 7: Special Topics Project Management for CSV Infrastructure for CSV Process Decomposition Selecting software for 21 CFR 11 Compliance Test Tools for CSV Lecture 8: Change Control & Business Continuity Change Control Implementing Business Continuity for CSV

3 Global CompliancePanel 2-day In-person Seminar: Validation and 21 CFR 11 Compliance of Computer Systems: Intermediate to Advanced Group Participation What You will get 10% 2 Attendees to get offer 1 Learning Objectives 20% 3 to 6 Attendees to get offer 2 Participation certificates 25% 7 to 10 Attendees to get offer 3 Interactive sessions with the US expert 30% 10+ Attendees to get offer 4 Post event assistance to your queries. Payment Option 5 Special price on future purchase of web based trainings. 1 2 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 6 7 Special price on future consulting or expertise services. Special price on future seminars by GlobalCompliancePanel. 3 PO: Please drop an to [email protected] or call the our toll free for the invoice and 8 Seminar Kit includes presentation handout, ID card, brochure, trainings catalog, notepad you may fax the PO to and pen. 4 Wire Transfer: Please drop an to [email protected] or call our toll free for the wire transfer 9 Networking with industry's top notch professionals information Contact Information: Event Coordinator NetZealous LLC, DBA GlobalComplianePanel 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA Toll free: Fax: Kindly get in touch with us for any help or information. Look forward to meeting you at the seminar GlobalCompliancePanel [email protected]