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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
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
PASSING A US FDA GMP INSPECTION: A-Z Guaranteeing a Pass the First Time through an FDA Inspection

PASSING A US FDA GMP INSPECTION: A-Z Guaranteeing a Pass the First Time through an FDA Inspection

  • Speaker: Michael Anisfeld
  • Product ID: 701026
  • Duration: 90 Min
In this FDA cGMP Inspection training learn all the background information and key Techniques needed to guarantee a cost-effective, first-time pass through an FDA inspection - whether for a pharmaceutical product, an active pharmaceutical ingredient (API), a medical Device or a biological production. The world of GMP compliance has dramatically changed with FDA stressing pre-approval inspections, risk management, investigations and CAPA, quality systems approaches, and process and analytical technology (PAT) applications. If you last passed an FDA inspection more than four years ago, or if you have never faced an FDA inspection, you will be unprepared for FDA’s 21st-century inspection methods. This course provides all the background information and key techniques needed to guarantee a cost-effective, first-time pass through an FDA inspection— whether for a pharmaceutical product, an active pharmaceutical ingredient (API), a medical device or a biological product. All API, medical device, diagnostic product manufacturer, biotechnology product or pharmaceutical manufacturers—no matter in which country they operate—must pass an on-site FDA inspection of their facilities and operations if products are to be sold in the United States.

This webinar is designed to provide background and insight into the inspection process, as well as practical strategies and tactics that a company must know and implement in order to have the potential to pass an inspection the first time through. The webinar covers everything you need to know—from the background to the inspection, including the importance of the commitments made in the product application (the DMF, the NDA, the BLA or the PMA). In addition we will discuss the differences between good science and GMP compliance issues. The inspection process itself will be analyzed and reviewed in a manner that will allow you to immediately begin effective strategizing on how to pass the inspection. Nothing has been left out. The course touches on everything, and we do mean everything, you need to know to have a smooth and successful inspection.

CD/Recorded
$249
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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
Preparing for a U.S. FDA Audit

Preparing for a U.S. FDA Audit

  • Speaker: John E Lincoln
  • Product ID: 700816
  • Duration: 60 Min
How to create and blend the Risk Management File findings into the company’s internal and external audit plans?
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
SOX: Internal Controls for Inventory

SOX: Internal Controls for Inventory

  • Speaker: Mike Morley
  • Product ID: 700359
  • Duration: 60 Min
Effective internal controls keep track of inventory and ensure that its proper value is reflected on the financial statements This presentation will provide you with the tools you need to establish and maintain strong internal controls for Inventory that meet Sarbanes-Oxley standards
CD/Recorded
$199
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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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Recorded/CD
Designing an Effective and Efficient Internal Audit Process for Your Quality Management System

Designing an Effective and Efficient Internal Audit Process for Your Quality Management System

  • Speaker: Michael A Mathe
  • Product ID: 700170
  • Duration: 60 Min
This webinar will focus on designing a thorough internal audit set of process tools, accurately captured in your internal audit procedure that will provide many years of payback and dividends for your organization.
CD/Recorded
$149
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Recorded/CD
Conducting Process Audits within both ISO 9001 and ISO 13485

Conducting Process Audits within both ISO 9001 and ISO 13485

  • Speaker: Diane Bove
  • Product ID: 700962
  • Duration: 90 Min
Emphasis is placed on conducting effective process auditing through an internal audit program within a company’s quality management system. This webinar is intended to review the requirements for determining if a company has its processes under control, with reviews of the requirements and description of the methods to determine which processes are expected to be audited.
CD/Recorded
$249
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Recorded/CD
Implementing a Risk-Based Internal CGMP Annual Audit Program

Implementing a Risk-Based Internal CGMP Annual Audit Program

  • Speaker: John E Lincoln
  • Product ID: 700427
  • Duration: 90 Min
How do you create and blend the Risk Management File findings into your annual audit plan? How is it established, maintained, formally updated, and documented? Structured, defined and scheduled internal CGMP compliance audits are a specific requirement of US FDA 21 CFR 820 and ISO 13485 (devices), implied in 21 CFR 210, 211 (pharma)
CD/Recorded
$149
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Recorded/CD
How to prepare for the unannounced FDA compliance inspection

How to prepare for the unannounced FDA compliance inspection

  • Speaker: Peter Calcott
  • Product ID: 700892
  • Duration: 60 Min
This webinar 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
$249
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