GMP Auditor Training for Quality Systems : Pharma Training Courses

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
Models

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’

GMP Auditor Training for Quality Systems