GMP Auditor Training for Quality Systems

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This 3 day course is aimed at Quality Assurance auditors and production management for Level 2 internal audits and supplier auditing.

Current GMP (Good Manufacturing Practice) legislation requires that there are internal and external audit programmes operating as part of an integrated quality system. Effective auditing should provide evidence of operational compliance status and identify opportunities for continuous improvement and improved supply chain control and relationships. Both internal auditors and supplier auditors need to have in-depth, interactive training in audit techniques and understand how audit activities complement quality and risk management processes to ensure business compliance and identify quality improvements.

Participants will learn about the key techniques and thought processes which can be used by auditors to maximize the benefits of each type of audit. These include planning and preparation, structuring the audit, managing the audit team, classifying observations , close out and reporting, CAPAs and follow up.

The course includes role play sessions to practice auditor / auditee communications. There is also a session on Data Integrity and implications of the US - EU MRA

Part 1: Auditing Basics
  • Purpose of audits
  • Justification for Quality, Compliance and Improvement
  • Role Characteristics of the Auditor
  • Desirable Audit Behaviours
Part 2: Auditing Types and
  • Audit types and themes
  • General model for audits
  • Quality Systems – a short history
Part 3: Audit Methods, Tools and Techniques
  • Basic auditing tools
  • Audit methods and techniques
  • Audit scheduling, planning and management
Part 4: The Audit Process
  • Audit scheduling
  • Conducting the audit
  • Managing an audit team
Part 5: Developing an Audit Plan and Aide Memoire
  • Workshop to develop audit plans and aide memoires
  • Conducting the Opening Meeting:
    role play workshop
Part 6: Internal Auditing and Improving the Audit System
  • Organisation of the internal audit programme (Self inspections)
  • Adding Value from the Audit programme
Part 7: How to Audit CAPA, OOS, OOT and QRM
  • Necessity for structured investigation
  • Corrective and Preventive Action procedures
  • Out of Specification and Out of Trend procedures
  • Risk Assessment techniques
Part 8: Auditing Products Manufacturers
  • Oral solid and liquid dosage forms
  • Packaging and labelling
  • Distribution
  • QC Laboratories
  • Computer systems
Part 9: Classification of Observations
  • Audit Reporting
  • Typical observation classification schemes
  • Workshop to classify a selection of typical observations
Part 10: Auditing for Approval of Suppliers/Contractors
  • Technical requirements (physical properties, purity, quantity, frequency, etc)
  • Critical steps and controls.
  • Preferred location (UK, EU, Far East, world-wide)
  • Key points of contract (Quality Technical Agreement)
Part 11: Auditing API Suppliers
  • Why Audit API Manufacturers
  • What is different about API operations
  • Control of raw materials and process intermediates
  • Manufacturing Deviations
  • QC Laboratories
  • Distribution
  • Computer systems
  • QP Declaration
Part 12: Data Integrity
  • 2015 MHRA Guidance, FDA Guidance and Definitions
  • Corporate Culture and Integrity
  • Examples of Data Integrity Issues
  • Types of Data Fraud
Part 13: Implications of the US-EU MRA
Part 14: Q&A, Course Review, Key Messages
  • Review of the course
  • Issue of certificates and course closure

The course will also compare and contrast paper and electronic documentation, electronic batch records and all quality systems items on an electronic system called Trackwise

Susan Rocca (GMP Auditor Training)

Susan is a Chemist who has held senior QA roles with fine chemical companies and latterly with GlaxoSmithKline.

Site roles included qualification of a new purified water system, design of a new archive building, redesign of a suite of laboratories to incorporate "Smart" instrumentation, plus day-to-day quality management and inspection preparation.

Head office roles included quality strategy development, interaction with commercial companies across the world, supply chain management, distribution quality risk management and cold/cool chain quality issue management.

Areas of Expertise

  • Active pharmaceutical manufacturing: complying with cGMP requirements
  • Experienced auditor for APIs, distribution and cold chain, in the UK, Europe, India, Singapore, Dubai, Mexico, Panama, Costa Rica, Puerto Rico and the USA
  • Auditing specialisation in good laboratory practice, distribution and cold chain
  • Incident management: troubleshooting and problem solving to "root cause". Rapid response to global quality issues
  • Quality management systems: development through simplification
  • Quality leadership: promoting that quality makes sense for a better business and helping quality departments integrate their plans with site business plans
  • Application of lean sigma tools to reduce errors and continuously improve processes
  • Application of quality procedures to non-manufacturing areas: eg logistics, commercial operations and regulatory processes
  • Inspection preparation, including one-to-one preparation clinics
  • Group training and one-on-one coaching for quality management understanding and application
  • Cold/cool chain processes for quality assurance
  • Preparation of sites for FDA, MHRA and other agency inspections, with successful outcomes
  • QA auditors and trainees
  • Production managers who receive internal QA and corporate GMP audits
  • Engineering managers who receive internal QA and corporate GMP audits
  • Production supervisors who lead Self Inspection audits
  • Auditors of suppliers and contractors

‘I really enjoyed
being introduced into the world of ‘Auditing’ by Susan Rocca’

‘Very good practical experience’

‘It is an interesting and helpful course’

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