SPEAKERMark 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.

COURSE DESCRIPTION

Analytical Instrument Qualification and System Validation2-Day In-Person Seminar

By: Mark Powell, Director, Mark Powell Scientific Limited

Location: San Francisco, CA | February 6-7, 2020

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.

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

02ANALYTICAL INSTRUMENT QUALIFICATION AND SYSTEM VALIDATION2-Day In-Person Seminar

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

AGENDA

08.30 AM - 09.00 AM - Registration09.00 AM - Session Start09.00 AM - 09.45 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 activities09.45 AM - 10.30 AM - Qualification in Practice

User requirement specifications

Installation qualification

Operational qualification

Preparing inspection-ready documentation10:30 AM - 11:00 AM - Break11.00 AM - 11.45 AM - Testing and deviation handling

Developing test protocols

Documenting test evidence

Review and approval of test results

Handling deviations11.45 AM - 12.30 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 approach12:30 PM - 13:30 PM - Lunch13.30 PM - 14.15 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

14.15 PM - 15.00 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 qualification15:00 PM - 15:30 PM - Break15.30 PM - 16.15 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 systems16.15 PM - 17.00 PM - 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

08.30 AM - 09.00 AM - Questions and answers from Day 109.00 AM - 10.00 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 integrity10:00 AM - 10:30 AM - Break10.30 AM - 11.15 AM - 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 changes11.15 AM - 12.00 Noon - 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 patches12:00 Noon - 13:00 PM - Lunch13.00 PM - 13.45 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 retrieval14:30 PM - 15:00 PM - Break15:00 PM - 16.15 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 observations16.15 PM - 16.30 PM - Wrap up - Final questions and answers

Day One (8:30 AM - 5:00 PM)

Day Two (8:30 AM - 4:00 PM)

ANALYTICAL INSTRUMENT QUALIFICATION AND SYSTEM VALIDATION2-Day In-Person Seminar

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Date & Location: .San Francisco, CA | February 6-7, 2020...DoubleTree by Hilton San Francisco Airport 835 Airport Blvd., Burlingame CA 94010-9949

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