Course Description:

In every laboratory inspection there are always two teams – the auditors and the auditees. Whether you are performing the audit or receiving the audit, there are rules, techniques and tips that will make your job more effective and reduce audit observations. This interactive and exciting seminar will look at various laboratory audits (GLP, cGMP, GCP, EPA) from both perspectives. You learn what auditor s look for, see examples of best practices and also hear war stories of things gone wrong as you get to experience both sides of the process. We will use presentation, discussion, exercises, role playing and workshops so that you experience what it is like to be an auditor and how to receive an audit.

This seminar will include overviews of the various regulations that affect laboratories and understand how they drive the audit, including 21CFR Part 11 as so many modern laboratories rely on computer-based data acquisition and reporting. We will provide forms and templates used in conducting audits, and train on when and how to utilize these tools. Each participant will write an audit observation as an auditor, and separately respond as an auditee to an observation and design a corrective action plan. We will explore all the aspects of laboratory operations including test methods validation, notebooks, instrument and equipment qualification, training records and data systems that are subject to audit.

You will leave these two days of training ready to receive an inspection with confidence in your new skills. You will be better prepared than ever before to be part of a less stressful audit with fewer observations.

Learning Objectives:

  • Be prepared to receive both internal and external audits.
  • Reduce the anxiety, costs and observations of audits.
  • Know what to say and show, and what Not to say and show.
  • Understand how auditors think and what they are looking for.
  • Write responses, audit observations, corrective actions and remediation plans.
  • Learn the best practices for test method validation, instrument qualification and data system validation to avoid observations (“483s”).
  • Know when to do what to meet audit requirements economically.
  • Have the answers to the auditors' questions.

Who will Benefit:

  • Laboratory Managers
  • Quality Assurance
  • Quality Control
  • Laboratory Analysts/Chemists
  • Analytical Development
  • Regulatory Compliance
  • Contract Laboratories
  • Contract Research Organizations
  • Contract Manufacturing Organizations
  • Auditors

Seminar Fee Includes:

AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

Course Outline and Approximate Times:

Day 1

Day 2

  • Introduction
  • Laboratory Audit Overview (90 minutes)
    • Types of audits
    • Regulatory Requirements
    • Internal/External/3rd-Party Audits
    • What’s Important?
    • Managing the Audit.
    • How to present documents
    • The Quality Pyramid – prioritizing risk
  • Quality Systems Inspection (60 minutes)
    • Quality Manuals and SOPs
    • Quality Organization
    • QSIT
    • Separation of Church & State
    • Good Documentation Practices
    • Paper and Electronic Laboratory Notebooks
    • Training Records
  • Workshop, Audit communication (30 minutes)
  • 21CFR Part 11 Compliance and Data Systems (150 minutes)
    • Laboratory Data Systems
    • 21CFR Part 11 Overview
    • Validation 101
    • Validation artifacts
    • System inventory and assessment
    • Remediation of Legacy Systems
    • Auditing Systems
    • LIMS ~ ELN
    • How to present data systems for inspection
  • Workshop, data system inspection forms(45 minutes)
  • Recap and Review (30 minutes)
  • Analytical Test Methods (75 minutes)
    • Chemistry/Bioassay
    • Elements of Validation
    • FDA versus USP method validation
    • ICH Q2 ~ USP 1225 ~ GLP/cGMP ~ EPA QA-RS
    • Phase-appropriate Method Qualification: When to do What
    • S.L.A.P. Up to Phase 1
    • Validation Documentation
  • Instrument Qualification (75 minutes)
    • Calibration
    • System Suitability
    • Preventive Maintenance
    • Research versus Regulated use
  • Audit Observations (75 minutes)
    • How to avoid them ‘on the fly’
    • How they are written
    • How to respond
    • How to write a corrective action
    • How to execute a remediation plan
  • Facility Qualification (45 minutes)
    • Risk-Based Validation
    • Validation versus Qualification versus Commissioning
    • Support Systems
    • Monitoring and Alarms
  • Workshop, Audit Observations: Writing responses (30 minutes)
  • Open Forum, Q&A, Conclusion (60 minutes)

Registration: 8AM TO 8:30AM
First session: 8:30 AM to 10AM
Am Break: 10AM TO 10:15AM
Lunch: 12PM to 1PM (Both Days)

Post Lunch Sessions: 1:00PM to 2:30PM
PM break: 2:30PM TO 2:45PM
Post Break session: 2:45PM TO 4PM (Both Days)

Meet Your Instructor

Dr. Richard Poser
President, First Quality Inc

Dr. Richard Poser has been both receiving and conducting audits in drug, laboratory, device, software and manufacturing environments for over 25 years and teaches from personal experience. He has been Director of Laboratories in both R&D, clinical phase and commercial operations in drugs and medical devices, and has been a consulting quality systems advisor or auditor to dozens of diagnostic, biologics, pharmaceutical and medical device manufacturers including many of the Fortune 500. Following many inspections he has been retained to design remediation and corrective actions to attain regulatory compliance. Dr. Poser is President and Lead Auditor for First Quality Inc., a consulting firm which has conducted hundreds of 3 rd -Party audits for laboratories, data systems and manufacturing operations. He has special expertise in data systems and 21CFR Part 11 compliance, and has worked with dozens of companies to validate systems used in regulated laboratories.

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