ComplianceOnline

“The Compliance Certification Board (CCB)® has approved this event for up to 13.8 live CCB CEUs. Continuing Education Units are awarded based on individual attendance records. Granting of prior approval in no way constitutes endorsement by CCB of this event content or of the event sponsor.”

Analytical equipment should be qualified, and computer systems should be validated to demonstrate suitability for their intended use. To be acceptable to regulatory authorities, electronic records must comply with 21 CFR Part 11, Annex 11 to EU GMPs and more recent data integrity guidance. Recent EU and FDA reports demonstrate that qualification, validation and electronic records are priority areas for inspection. The large number of FDA warning letters and the frequency of EU enforcement action in these areas demonstrate that companies sometimes struggle to understand or implement the regulations.

This 2-day course guides attendees through equipment qualification, calibration and computer system validation processes from planning to reporting. It also explains regulatory requirements in these areas, including EU and US GMPs, as well as data integrity guidance documents from national and international regulatory bodies.

The course not only ensures a full understanding of the regulations and guidelines for equipment and records but helps attendees to develop a risk-based approach to compliance. Interactive exercises will be dispersed into and between the presentations.

Learning Objectives:

  • Learn about the regulatory background and requirements for equipment qualification according to USP <1058> and computer system validation according to GAMP 5
  • Be able to explain the difference between equipment calibration, qualification and system validation
  • Learn which equipment/systems need to be qualified or validated
  • Be able to allocate equipment and systems to USP <1058> and GAMP 5 categories and to design and execute qualification/validation protocols accordingly
  • Understand the logic and principles of instrument qualification and system validation from planning to reporting
  • Be able to develop a qualification and validation strategy
  • Understand how to archive raw data from hybrid systems: electronic vs. paper
  • Be able to define and demonstrate regulatory compliance to auditors and inspectors
  • Be able to develop inspection-ready documentation
  • Learn how to ensure, document and audit the integrity of GMP records

In-Person Seminar going Virtual with increased learner satisfaction.

Yes, attend this seminar from anywhere. We are making it real and more interactive – Here's a sneak peek:

Our enhanced delivery process and technology provides you an immersive experience and will allow you to access:

  • The real-time and live presentation as in in-person events
  • Private chat for company-specific conversation – the same as you would get in an in-person seminar
  • Opportunities to connect with your peers to share knowledge at a different time and have group discussions
  • Live workshop activities
  • Live Q&A during the event and offline Q&A assistance after the event
  • As usual more content, activities and case studies and now adding homework for a comprehensive understanding
  • Certification

Who will Benefit:

  • IT/IS managers and system administrators
  • QA managers and personnel
  • Laboratory managers and supervisors
  • Analysts
  • Validation specialists
  • Software developers
  • Regulatory affairs
  • Training departments
  • Documentation departments
  • Consultants
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Day 01(10:00 AM - 5:00 PM EDT)
  • 10.00 AM - 10.45 AM - Requirements and approaches for Analytical Instrument Qualification
    • FDA/EU, PIC/S requirements
    • Qualification/calibration issues in FDA inspections
    • USP General Chapter <1058>: Analytical Instrument Qualification
    • The instrument qualification lifecycle
    • Prioritizing calibration/qualification activities
  • 10.45 AM - 11.30 AM - Qualification in Practice
    • User requirement specifications
    • Installation qualification
    • Operational qualification
    • Preparing inspection-ready documentation
  • 11:30 AM - 11:45 AM - Break
  • 11.45 AM - 12.45 PM - Testing and deviation handling
    • Developing test protocols
    • Documenting test evidence
    • Review and approval of test results
    • Handling deviations
  • 12:45 PM - 1:15 PM - Lunch
  • 1.15 PM - 2.30 PM - Retrospective qualification and Requalification
    • Qualification of existing systems
    • Leveraging past experience
    • Time-based requalification
    • Event-based requalification
    • What and how much to test – risk-based approach
  • 2.30 PM - 3.15 PM - Equipment Maintenance and Change control
    • Preventive maintenance; tasks, documentation
    • Planned and unplanned changes
    • Changing hardware, firmware, documentation
    • Definition and handling of like-for-like changes.
    • Handling changes made by vendors
  • 3.15 PM - 4.00 PM: Type and extend of qualification for USP Instrument Categories
    • The approach and benefits of instrument categories
    • How to identify the correct category: A, B, C
    • Type and extent of qualification for each category
    • Required procedures and qualification deliverables
    • Responsibilities for instrument qualification
  • 4:00 PM - 4:15 PM - Break
  • 4.15 PM - 5.00 PM - Requirements and approaches for GMP Computer Systems
    • 21 CFR Part 211, Part 11, PIC/S, EU Annex 11
    • Most critical inspection findings
    • Which systems need to be validated
    • GAMP 5: A Risk based Approach to Laboratory Computerized Systems
    • Examples for risk assessment of computer systems
  • Validation of Laboratory Computer systems
    • Writing a validation project plan
    • Integrating GAMP 5 with USP <1058> for instrument and computer system validation
    • Writing a validation report
Day 02(10:00 AM - 5:00 PM EDT)

  • 10.00 AM - 10.15 AM - Questions and answers from Day 1
  • 10.15 AM - 11.00 AM - Validation and Use of Excel in the QC Laboratory
    • Designing spreadsheets for compliance
    • Validation approach for spreadsheets – single and multiple-use spreadsheets
    • When, what and how much to test?
    • GAMP 5 recommendations
    • How to ensure spreadsheet data integrity
  • 11:00 AM - 11:15 AM - Break
  • 11.15 AM – 12.15 PM - Configuration management and change control
    • The IEEE standard for configuration management
    • The change control process for planned changes
    • Unplanned changes
    • Upgrading software
    • What to test after changes
    • How to document changes
  • 12.15 PM – 1.00 PM - Periodic revalidation of chromatography data systems
    • The approach and practice of periodic review
    • Using periodic review to reduce frequency of revalidation
    • Criteria for time-based revalidation
    • Incidents requiring revalidation
    • Validation tasks after installing security and other patches
  • 1:00 PM - 1:45 PM - Lunch
  • 1.45 PM - 2.30 PM - Handling raw data and other laboratory records
    • Definition of raw data: electronic vs. paper
    • Acquisition and recording of raw data
    • How to make accurate and complete copies of raw data
    • Changing records
    • Archiving of raw data and ready retrieval
  • 2.30 PM - 3.00 PM - Ensuring Integrity and Security of GMP data
    • Most frequent security and integrity issues
    • The importance of electronic audit trails
    • Review of electronic audit trails: who, what, when and how
  • 3:00 PM - 3:15 PM - Break
  • 3:15 PM - 4.30 PM - Auditing Laboratory Computer Systems
    • Using FDA inspection practice
    • Importance of data governance policy and controls
    • Preparing inspection-ready documentation
    • Responding to typical inspectional/audit observations
  • 4.30 PM - 5.00 PM - Wrap up - Final questions and answers
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Mark Powell

Mark Powell
Director, Mark Powell Scientific Limited

Dr Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as an analytical chemist. Mark was Honorary Treasurer of the RSC’s Analytical Division and led a working group on continuing professional development until July 2016, when his term of office ended. Between 2003 and 2013, he was the Analytical Development Manager, and later Scientific Manager, of a UK-based contract research organization which specialized in early-stage oral drug development. During this time, he was responsible for method validation, verification and transfer activities, as well as the qualification of laboratory instruments and computerized data systems. In 2013, he set up Mark Powell Scientific Limited, which provides training and consultancy services to pharmaceutical companies. Mark has since enjoyed working with companies of all sizes around the world on a variety of training and consultancy assignments, and has recently co-authored a White Paper on Pharmaceutical Data Integrity for the laboratory supply company VWR.

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

Register Now

Online using Credit card


Get the Invitation
Pre-Register yourself and get the official Invite when venue and dates are announced for this seminar.
Call here to register +1-888-717-2436 or email at customercare@complianceonline.com

Other Registration Option

By order form / PO#

Payment Mode

By Check -
Pay your check to (payee name) “MetricStream Inc” our parent company and Mail the check to:

ComplianceOnline (MetricStream, Inc),
6201 America Center Drive Suite 240
San Jose, CA 95002
USA

By Wire -

Register / Pay by Wire Transfer

Please contact us at +1-888-717-2436 to get details of wire transfer option.

Terms & Conditions to Register for the Seminar/Conference/Event

Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ customercare@complianceonline.com

Payment:

Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).

Cancellations and substitutions for In-person Seminars:

Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Cancellations and Substitutions for Virtual Seminars & Webinars:

Written cancellations through fax or email (from the person who has registered for the training) received at least 10 calendar days prior to the start date of the event will receive a refund — less a 30% administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event. On request by email or fax (before the training) a credit for the amount paid minus administration fees (30%) will be transferred to any future ComplianceOnline event and a credit note will be issued. Substitutions may be made at any time. No-shows will be charged the full amount. Some topics and speakers may be subject to change without notice.
Offers:
  • Early bird seats are limited and based on first-come, first-serve.
  • Multiple offers cannot be combined.
  • We need below information to serve you better

    Best Sellers
    You Recently Viewed
      Loading