Analytical Instrument Qualification and System Validation (com) A

Analytical Instrument Qualification and System Validation

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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.

Seminar Fee Includes:

Lunch

AM-PM Tea/Coffee

Seminar Material

USB with seminar presentation

Hard copy of presentation

Attendance Certificate

$100 Gift Cert for next 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

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

AGENDA

Day 01(8:30 PM - 5:00 PM)

08.30 AM - 09.00 AM - Registration

09.00 AM - Session Start

09.00 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 activities

09.45 AM - 10.30 AM - Qualification in Practice

User requirement specifications

Installation qualification

Operational qualification

Preparing inspection-ready documentation

10:30 AM - 11:00 AM - Break

11.00 AM - 11.45 AM - Testing and deviation handling

Developing test protocols

Documenting test evidence

Review and approval of test results

Handling deviations

11.45 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 approach

12:30 PM - 13:30 PM - Lunch

13.30 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 qualification

15:00 PM - 15:30 PM - Break

15.30 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 systems

16.15 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

Day 02(8:30 AM - 4:00 PM)

08.30 AM - 09.00 AM - Questions and answers from Day 1

09.00 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 integrity

10:00 AM - 10:30 AM - Break

10.30 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 changes

11.15 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 patches

12:00 Noon - 13:00 PM - Lunch

13.00 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 retrieval

13.45 PM - 14.30 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

14:30 PM - 15:00 PM - Break

15:00 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 observations

16.15 PM - 16.30 PM - Wrap up - Final questions and answers

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.

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