USFDA India Seminar 2011 at Mumbai on Validation of Methods and Processes

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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