How To Be An Effective GMP Auditor – Part 3
Description:
The US Food and Drug Administration (FDA) is responsible for regulating the safety, efficacy, and quality of therapeutic products that save or improve human lives. Firms looking to approve pharmaceuticals, biopharmaceuticals, and medical devices must comply with these regulations or face sanctions and/or setbacks. FDA pre-approval inspections will focus on the past (corroboration of the data on which approval will be based), present (your organizational structure, delegation of responsibilities, written procedures, quality systems, culture of compliance) and future (your understanding and readiness for post-approval statutory obligations, including commercial vigilance plans).
Curriculum for this course:
Introduction
Overview | 1 min 42 secs |
Learning objectives | 1 min 30 secs |
Who should take this course? | 1 min 50 secs |
Course modules | 1 min 38 secs |
Module 1: Introduction to GMP Auditing
What is an audit? | 1 min 50 secs |
Why GMP audit? | 2 min 11 secs |
Safety, business and compliance | 1 min 13 secs |
Types of GMP audits | 2 min 29 secs |
Internal audit (Self inspection) | 1 min 56 secs |
Regulatory audits | 1 min 44 secs |
Who conducts GMP audits? | 2 min 34 secs |
Key principles of GMP audits – Auditors | 1 min 26 secs |
Key Principles of GMP audits – Process | 1 min 37 secs |
Benefits of GMP audits | 2 min 48 secs |
Module 2: The GMP Audit Process
The GMP audit process | 1 min 48 secs |
Phase 1: Preparation and Planning of the GMP Audit
Determine the basis for the audit | 2 min 01 secs |
What is the purpose of the audit? | 1 min 15 secs |
What is your role? | 1 min 39 secs |
What are the standards? | 2 min 02 secs |
What is the scope? | 1 min 21 secs |
Determine the feasibility of the audit | 1 min 31 secs |
Review documents | 1 min 39 secs |
Prepare the audit plan | 2 min 20 secs |
Audit plan communication | 1 min 33 secs |
Prepare work documents | 1 min 50 secs |
Phase 2: Performing the Quality Audit
The audit process | 1 min 29 secs |
The opening meeting | 2 min 10 secs |
Avoid unproductive meetings | 1 min 10 secs |
The site area tour | 1 min 36 secs |
Collect information | 1 min 42 secs |
Interviews | 1 min 51 secs |
Records review | 1 min 41 secs |
Observations | 1 min 37 secs |
Beginning the conference room pilot | 1 min 49 secs |
Auditing techniques | 1 min 08 secs |
Horizontal auditing | 2 min 39 secs |
Vertical auditing | 2 min 07 secs |
The ideal combination | 1 min 55 secs |
Other auditing techniques | 1 min 19 secs |
General audit findings | 2 min 01 secs |
The daily wrap up | 1 min 47 secs |
Classify audit observations | 1 min 19 secs |
Critical deficiency | 1 min 29 secs |
Major deficiency | 1 min 58 secs |
Minor/Other deficiency | 1 min 31 secs |
The close-out meeting | 1 min 39 secs |
Phase 3: Preparation, Approval & Distribution of the Audit Report
Preparation of the audit report | 1 min 22 secs |
Report comments | 2 min 39 secs |
What should not be in the report | 1 min 50 secs |
Approve and distribute the audit report | 1 min 42 secs |
Conduct follow up audit | 1 min 58 secs |
Phase 4: Audit Closure
Module 3: The System Based Approach
Typical systems | 1 min 17 secs |
Quality assurance system | 2 min 09 secs |
Validation / qualification system | 1 min 04 secs |
Material system | 1 min 45 secs |
Premises and equipment systems | 1 min 51 secs |
Packaging and labelling systems | 2 min 09 secs |
Laboratory control systems (LIMS) | 1 min 34 secs |
Research and development systems (R&D) | 1 min 42 secs |
Engineering and maintenance systems | 1 min 53 secs |
Utilities systems | 1 min 16 secs |
Warehousing systems | 1 min 54 secs |
Module 4: The GMP Auditor
How to be a successful auditor | 1 min 40 secs |
Professional experience | 1 min 44 secs |
Knowledge and skills | 1 min 29 secs |
Audit principles | 1 min 31 secs |
Management systems and references | 1 min 22 secs |
Organizational situations | 1 min 19 secs |
Law and regulatory requirements | 1 min 55 secs |
Personal suitability | 1 min 10 secs |
Difficult situations | 1 min 19 secs |
Module 5: Examples of Audit Findings
Examples of GMP non-compliance | 1 min 10 secs |
Quality systems | 1 min 30 secs |
Facility systems | 1 min 41 secs |
Equipment systems | 1 min 44 secs |
Material systems | 1 min 49 secs |
Production and process control systems | 1 min 51 secs |
Packaging and labelling | 1 min 30 secs |
Laboratory control systems | 1 min 22 secs |
Organizational and personnel | 1 min 15 secs |
Records and reports | 1 min 58 secs |
Returned and salvaged products | 1 min 09 secs |
Conclusion
Final Assessment
Certification
Revision History
Updated name from "FDA Inspection Readiness – Part 3" to "How to be an Effective GMP Auditor – Part 3" | V2.0 |
Redesigned course with new Articulate Storyline player | V2.0 |
Added new final exam question to align with learning objectives | V2.0 |
Updated Glossary links | V2.0 |
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