Agenda:

Day One


Lecture 1:

Requirements and approaches for Instrument Qualification and Computer System Validation

  • FDA/EU, ICH and PIC/S requirements
  • Lessons from recent FDA warning letters
  • Understanding the terminology: qualification, calibration, verification, validation.
  • EU/PICS GMP Annex 15: Validation and Qualification
  • USP Chapter <1058> for analytical instruments: current and proposed changes
  • Lessons from GAMP®5 and from the GAMP® guide: "A Risk based Approach to Laboratory Systems"
  • Planning for cost-effective qualification and validation
  • Which systems require qualification/validation

Lecture 2:

Going through the equipment qualification phases

  • Develop a project plan from the master plan
  • Writing requirement specifications
  • Documenting installation and installation qualification
  • Testing for initial operational qualification
  • System Suitability testing for performance qualification
  • Preparing and executing test protocols
  • Preparing inspection ready documentation
  • Maintenance, requalification and change control

Lecture 3:

Cost Effective Validation of Computer Systems: Step-by-Step - Part 1

  • Selecting the right validation lifecycle model
  • Going through examples of a complete computer system validation from beginning to end
  • Rrisk assessment for type and extend of validation
  • Defining user requirements based on risk
  • Vendor assessment and supplier agreements
  • Testing and documenting installation
  • Going through examples for OQ and PQ testing
  • Writing the validation report

Lecture 4:

Validation of Computer Systems - Part II

  • Leveraging validation efforts of identical systems
  • Validation of existing equipment and computer systems
  • Preparing inspection ready validation documentation
  • Integrating the GAMP® guide with USP <1058> for integrated instrument and system validation
  • IT infrastructure qualification and validation of networked systems
  • Validation and use of cloud computing in FDA/EU regulated environments
  • Recommendations for different cloud models and services
  • Validation of mobile apps

Day Two


Lecture 1:

Validation and control of Excel spreadsheet applications

  • Designing spreadsheets for compliance
  • Validation approach for spreadsheet applications
  • When, what and how much to test?
  • Recommendations from GAMP®5 for testing native Excel functions
  • How to ensure spreadsheet and data integrity
  • Going through examples
  • Excel spreadsheet validation from beginning to the end: A case study that can be used by everybody

Lecture 2:

Maintaining the validated state of computer systems

  • Ongoing training of users and IT staff
  • System maintenance and data backup
  • Change control: Handling planned and unplanned changes, e.g., handling security patches
  • Periodic review vs. revalidation
  • Disaster recovery and business continuity
  • Retirement of computer systems and data migration

Lecture 3:

Introduction to FDA 21 CFR Part 11 and EU/PICS Annex 11

  • Objective, scope, current situation and future of Part11
  • Requirements overview and spirit of the regulation
  • Requirements for electronic records
  • Requirements for electronic and digital signature
  • Additional requirements from the PICS/EU Annex 11, from the UK MHRA and from the WHO GMP data integrity guidelines
  • FDA/EU inspection and enforcement practices of electronic records: examples of recent FDA warning letters
  • User requirements for Part11/Annex 11 based on risk
  • Upgrading old or purchasing new systems: compliance and business aspects
  • Six steps for implementation of Part11/Annex 11

Lecture 4:

Ensuring and documenting Integrity of Laboratory (Raw)data and other Records

  • Definition of raw data: FDA/EMA requirements
  • What to archive for hybrid systems: paper records or electronic records
  • The importance of electronic audit trail to document data integrity
  • Review of electronic audit trail: who, what, and how
  • How to ensure availability of electronic records throughout the entire retention period
  • Steps for validating security and integrity functions
  • Examples how to ensure and document data integrity and security
  • Preparing your company for data integrity audits

**Price Does Not Include Taxes, Please make the cheque with additional 14% on this amount

You can register for this seminar paying either by cheque or Demand Draft. To register, please make out your cheque or Demand Draft for the prescribed amount and send it to the address given below:
NetZealous Services India Pvt. Ltd.
Gururaya Mansion, 759 to 764, 8th Main road, J.P.Nagar,
Bangalore - 560078 Karnataka, INDIA

  • Group participations
  • Discount Slab: 5 or more participants 10% discount
    To avail the above group discounts, all the participants should register by making a single payment.
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Venue:

The Leela Mumbai Andheri Kurla Road, Sahar Village, Andheri-Kurla Road, Mumbai, Maharashtra 400059

Speaker:

Dr. Ludwig Huber

Chief Advisor - Global FDA compliance, Agilent Technologies

  • Chairman, presenter and panel discussion member at US-FDA Industry Training sessions and conferences
  • Served as team member of PDA's task forces "21 CFR Part 11", of US-FDA internal documents, and of the GAMP® special interest group on Laboratory Systems.
  • Presenter of the Year of the Institute for Validation and Technology
  • Director and chief editor of www.labcompliance.com, the global on-line resource for validation and compliance issues for laboratories.
  • Author of the books "Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems"

Mumbai Local Attractions

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Mani Bhavan Gandhi Museum

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Bandra-Worli Sea Link

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Marine Drive

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Gateway of India

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Chowpatty Beach

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Chhatrapati Shivaji Terminus

Our Address

NetZealous Services India Pvt. Ltd.
Gururaya Mansion, 759 to 764, 8th Main road, J.P.Nagar,
Bangalore - 560078 Karnataka,INDIA.
Toll free: 1800 425 9409
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