FDA Inspection Readiness – Part 1

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Description:

A significant part of the FDA pre-approval process remains inspection actions by the agency to ensure quality, consistency, and safety. Readiness for these inspections is paramount. Having bullet-proof data, documentation, standard operating procedures (SOPs) and other items in place is just part of the puzzle. The people who handle these inspections and all interactions with FDA must be thoroughly screened and selected as well. Since this is likely your “first impression” with FDA, you have no choice but to get it right.

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
Inspections	2 min 08 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	2 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