Analytical Instrument Qualification and System Validation (com) A

ANALYTICAL INSTRUMENT QUALIFICATION AND SYSTEM VALIDATION *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY! 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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