Validation and 21 CFR Part 11 Compliance of Computer Systems on USFDA India Seminar 2011 at Mumbai

July 21, 2011 - PRLog -- Day 1 - 15th September 2011
Module 1: Regulatory requirements and recommendations from Industry Task Forces
•FDA and EU requirements for software and computer system validation
•FDA Inspection and Enforcement Practice How does validation help to improve your business
•Examples of recent Warning Letters and 483s
•Computer validation according to GAMP 5
•Which systems need to be validated
•Selecting the right validation approach for commercial off-the-shelf system
•Using the risk based validation approach to lower costs
•Step-by-step instruction for risk assessment according to most recent guidelines
•Workshop Exercises

Module 2: Eight Steps for Cost Effective Computer System Validation
•Forming the validation team: Selecting the right members and a project leader
•Planning for effective implementation
•Writing meaningful specifications
•Selecting and qualifying the right vendor using the risk based apprach
•Preparing the site for installation
•Installing and testing the system for correct operation
•Testing during on-going use: what and how
•Validating existing systems
•Change control and revalidation
•Workshop exercises

Module 3: Initial and ongoing tests of software and computer systems
•How to reduce costs though risk based testing using the traceability matrix
•Justify and document what and how much to test
•Leveraging vendor testing
•Understanding FDA warning letter phrases: testing for worst cases, high load, limit
•Testing COTS systems according to GAMP V
•Developing a test plan and protocols
•Required training documents of IT professionals and test engineers: don't forget GMP training
•How to conducting and document tests: demonstrating test evidence
•Review and approval of test protocols
•Handling deviations
•Workshop exercises

Module 4: Minimum Validation Documentation Inspectors want to see
•Basic requirements of the GMP – Part 2.
•Packaging and Labeling Controls
•Holding and Distribution
•Laboratory Controls
•Records and Reports
•Returned Goods and Salvaging

 
   
Day 2 - 16th September 2011
Module 5: Validation and Use of Excel Spreadsheets in regulated environments
•Regulatory requirements for spreadsheets; FDA Part 11, PIC/S Good Practice Guide. and the EU Annex 11
•Recommendations from the new GAMP'5
•How does FDA use Excel to comply with its own regulations: going through two FDA information bulletins
•How to design spreadsheets for compliance.
•The reduced lifecycle for cost effective validation
•How to ensure and validate spreadsheet integrity.
•When, what and how much to test?
•Validation of standard/native Excel functions?
•Specifics of Excel spreadsheets and Macro programs

Module 6: Qualification of Network Infrastructure and Validation of Networked Systems
•Why to qualify infrastructure if we validate the system anyway
•Recommendations from FDA and GAMP
•Configuration management and change control as the most important network qualification steps
•Qualification of PC clients, servers, data centers
•What and how much to test with the risk based cost/benefits in mind:
•Qualification of network components, servers, PC clients,
•Documentation requirements: SOP, installation and test scripts, system diagrams, change logs
•Going through a real life inspection

Module 7: Understanding the spirit and basics of the FDA Part 11 and the EU GMP Annex 11
•FDA and EU requirements for electronic records and signatures: similarity and differences
•FDA inspection and enforcement practices of electronic records: examples of recent FDA warning letters
•History, current status and future of Part 11 and Annex 11

Module 8: Learn how to ensure and document data integrity for Part 11/EU Annex 11 Compliance
•What to archive for hybrid systems: paper records or electronic records
•Justification and documentation your approach towards Part 11/Annex 11 documentation
•Raw data: Definition, acquisition, maintenance and archiving
•Defending data security and integrity
•Audit trail: the most important function to demonstrate data integrity
•FDA expects to review audit trails: who, what, how many times
•When do we must keep e-records after print out: 5 eye opening case studies
•Auditing computer systems for Part 11/Annex 11 compliance

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