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Home › Online Training ›  Audit & Inspection-Role

Audit and Inspection Training - Live Webinars, Recordings & CDs

The courses on this page cover pre-audit preparations, during audit processes, post-audit processes, Dos and Don'ts, and more. The programs cover regulatory audits, internal audits, and other quality audits. Browse our wide range of courses designed to help you identify your strengths and problem areas, find solutions, and boost your morale.
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Recorded/CD
Critical Control Points (CCP’s). Where are they? Why? When?

Critical Control Points (CCP’s). Where are they? Why? When?

  • Speaker: Irwin Pronk
  • Product ID: 701180
  • Duration: 60 Min
This Food safety compliance training will explain the CCP Decision Tree and help you understand the principles behind each question. We will review various food processing steps in a variety of situations to determine whether they are CCP’s. What is the thought process in determining a CCP? Can it be done consistently? What criteria are used? Are some processing steps always CCP's e.g. heating? If not, why? One thing to remember is the importance of analyzing the hazards at each step very carefully. The more clearly the hazards are described (including equipment failures, personnel errors etc) the easier it will be to find the CCP.
CD/Recorded
$199
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Recorded/CD
cGMP 'Pitfalls' in the QC Laboratory-Preparing the QC Laboratory and Staff for an FDA Inspection

cGMP 'Pitfalls' in the QC Laboratory-Preparing the QC Laboratory and Staff for an FDA Inspection

  • Speaker: Michelle Sceppa
  • Product ID: 701187
  • Duration: 60 Min
The FDA Audit inspection training defines the laboratory environment; points out problem areas and common pitfalls; and details solutions and also details how to prepare the Laboratory staff for an Inspection as well.
CD/Recorded
$299
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Recorded/CD
Surprise FDA GMP inspection - how to prepare for it

Surprise FDA GMP inspection - how to prepare for it

  • Speaker: Peter Calcott
  • Product ID: 701203
  • Duration: 90 Min
This FDA GMP (Good Manufacturing Practice) inspection training will walk you through the elements you should plan for, the timing and the logistics of who should do the various components in preparation for the inspection.
CD/Recorded
$299
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Recorded/CD
Auditing Failure or Process Deviation Investigations

Auditing Failure or Process Deviation Investigations

  • Speaker: Michelle Sceppa
  • Product ID: 701128
  • Duration: 42 Min
This FDA Inspection training will examines the audit process and how to manage Process Deviation Investigations.
CD/Recorded
$149
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Recorded/CD
How to conduct a Clinical Trial in accordance with FDA regulations and how to avoid the common deficiencies observed during FDA clinical audits

How to conduct a Clinical Trial in accordance with FDA regulations and how to avoid the common deficiencies observed during FDA clinical audits

  • Speaker: Elizabeth Bergan
  • Product ID: 701054
  • Duration: 90 Min
This Clinical Trial training will provide a detailed review of the FDA regulations for Clinical Trials Process. This presentation will provide a detailed review of the FDA regulations for Clinical Trials Process. After attending this session, participants will have an understanding of FDA regulations pertaining to the implementation of clinical trials and concepts of Good Clinical Practice (GCP) and Bioethics.
CD/Recorded
$199
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Recorded/CD
Internal Control: Concepts & Application

Internal Control: Concepts & Application

  • Speaker: Bernice Russell Bond
  • Product ID: 701046
  • Duration:
This workshop will provide you with the knowledge necessary to apply the COSO model in order to manage your business risk. Today when we talk about internal control, we’re talking about a new standard. Promulgated by the Committee of Sponsoring Organizations (COSO), also known as the Treadway Commission, which has caused a paradigm shift where the emphasis is on identification and management of business risks.This workshop will provide you with the knowledge necessary to apply the COSO model in order to manage your business risk.
CD/Recorded
$199
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Recorded/CD
GxP Computer Systems Validation: The Investigator's Point of View

GxP Computer Systems Validation: The Investigator's Point of View

  • Speaker: Dale Hunscher
  • Product ID: 701069
  • Duration: 60 Min
In this presentation, we will look at these documents from the investigator’s point of view, reviewing the FDA training manual and actual FDA warning letters and responses. This will reveal what the investigator is trained to look for and what types of problems are actually being discovered in the field offices.
CD/Recorded
$249
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Recorded/CD
FDA at the Door: Ten Essential Steps for Inspection Success

FDA at the Door: Ten Essential Steps for Inspection Success

  • Speaker: Anne E Maczulak
  • Product ID: 701090
  • Duration: 60 Min
This FDA inspection training compiles the best practices now being used by many companies to host FDA inspections that will satisfy FDA inspectors and result in a good experience for the company. FDA inspections require a large amount of preparation and knowledge. Are you informed enough to avoid Warning Letters
CD/Recorded
$299
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Recorded/CD
The Secret of Study Conduct Documentation to ensure a successful Audit: What the FDA Inspectors looks for

The Secret of Study Conduct Documentation to ensure a successful Audit: What the FDA Inspectors looks for

  • Speaker: Charles H Pierce
  • Product ID: 701075
  • Duration: 90 Min
This FDA audit training will provide invaluable assistance to investigators and their staff in the regulatory / legal responsibilities and also the ethical considerations in pharmaceutical product (Drug or device) research involving human subjects. Data keeping for clinical research trials involving human subjects has to be as accurate and valid as possible. Does yours meet the mark?
CD/Recorded
$249
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Recorded/CD
Japan PAL Audits performed abroad by the PMDA: What to expect and how to prepare

Japan PAL Audits performed abroad by the PMDA: What to expect and how to prepare

  • Speaker: Phil Smart
  • Product ID: 701049
  • Duration: 90 Min
This training course will concentrate on how to prepare for the audit, from language and culture to technical requirements and auditor expectations. Due to the 2005 revisions in the Japanese Pharmaceutical Affairs Law (PAL), the PMDA - Pharmaceuticals and Medical Devices Agency - is beginning to step up its scheduling of on-site audits of foreign medical device manufacturers.
CD/Recorded
$249
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Recorded/CD
NEW Guidance for Industry: CGMP for Phase I Investigational Drugs

NEW Guidance for Industry: CGMP for Phase I Investigational Drugs

  • Speaker: Jamie Jamshidi
  • Product ID: 701064
  • Duration: 90 Min
This guidance is intended to assist in applying current good manufacturing practice (CGMP) required under section 501(a) (2) (B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in the manufacture of most investigational new drugs (IND).
CD/Recorded
$149
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Recorded/CD
A FDA Audit - What You Need to Know

A FDA Audit - What You Need to Know

  • Speaker: Bernice Russell Bond
  • Product ID: 701042
  • Duration: 90 Min
This presentation will provide you with the tools to prepare for and support the audit process executed by regulatory bodies.
CD/Recorded
$249
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Recorded/CD
How to Establish Quality Objectives that Produce Results

How to Establish Quality Objectives that Produce Results

  • Speaker: Diane Bove
  • Product ID: 700965
  • Duration: 90 Min
The webinar provides a comprehensive and logical way to think about performance goals, metrics and the evaluation of goal progress.
CD/Recorded
$249
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Recorded/CD
What We Can Learn From Warning Letters

What We Can Learn From Warning Letters

  • Speaker: Anne E Maczulak
  • Product ID: 700946
  • Duration: 90 Min
In this Good Laboratory Practices training on FDA warning letter learn how to avoid making the same mistakes in your study and to avoid having your company's name publically cited for inspection findings.
CD/Recorded
$249
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Recorded/CD
Investigations and Corrective/Preventive Actions

Investigations and Corrective/Preventive Actions

  • Speaker: Nick Campbell
  • Product ID: 701019
  • Duration: 60 Min
In this seminar, you will learn how to document unexpected situations accurately and completely. Are your investigations done haphazardly or in an inconsistent manner? Are your reports hard to understand? Is the discrepancy resolution process slowing your product release efforts unnecessarily?
CD/Recorded
$249
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Recorded/CD
What to Expect During an FDA Inspection, and How to Handle It

What to Expect During an FDA Inspection, and How to Handle It

  • Speaker: Jeff Kasoff
  • Product ID: 700987
  • Duration: 60 Min
This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection. This session will be the limits of FDA’s scope during an inspection, including what documents you are not required to show them, and the permissibility of photographs and affidavits.
CD/Recorded
$249
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Recorded/CD
Preparing for FDA Pre-Approval Inspections

Preparing for FDA Pre-Approval Inspections

  • Speaker: Peter Calcott
  • Product ID: 700894
  • Duration: 60 Min
An assessment of your people to determine who should be talking with the FDA and most importantly, who should not must be performed. This webinar will provide the process map for the compliance and quality staff to build their strategy and plans for preparing for and executing their preparation work for a PAI in the Pharmaceutical and Biotechnology world.
CD/Recorded
$249
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Recorded/CD
How to Prepare for FDA GMP Inspections

How to Prepare for FDA GMP Inspections

  • Speaker: James Harris(PhD)
  • Product ID: 700990
  • Duration: 60 Min
This program outlines a system for preparing for an unexpected inspection and details SOPs that should be established in advance of the appearance of an inspector at your front door. This Webinar will provide valuable assistance to all regulated companies that face unscheduled inspections by regulatory agencies.
CD/Recorded
$99
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Recorded/CD
Investigator responsibility/Legal commitment in drug and device clinical research: the reality

Investigator responsibility/Legal commitment in drug and device clinical research: the reality

  • Speaker: Charles H Pierce
  • Product ID: 700923
  • Duration: 90 Min
To follow the regulations is Good Clinical Practices (GCP) and common sense. To not know and follow these regulations is folly. This Webinar will provide invaluable assistance to investigators and staff with regulatory/ legal responsibilities. It also delves into the complex ethical considerations in pharmaceutical product (drug or device) research involving human subjects.
CD/Recorded
$249
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Recorded/CD
Learning from Laboratory-related FDA Warning Letters

Learning from Laboratory-related FDA Warning Letters

  • Speaker: Steven S Kuwahara
  • Product ID: 700951
  • Duration: 90 Min
This presentation will cover laboratory-related warning letters that contain 483s related to regulatory issues that affect pharmaceutical companies. While recent warning letters will receive the heaviest scrutiny, we will also cover old warning letters that serve to illustrate important points.
CD/Recorded
$249
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