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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
How to Audit the Difficult Areas of a Quality Management System

How to Audit the Difficult Areas of a Quality Management System

  • Speaker: Larry Whittington
  • Product ID: 700334
  • Duration: 60 Min
This webinar will provide guidance on how to audit the more difficult areas of a quality management system The applicable ISO 9001:2000 requirements will be examined for each of these difficult areas and then suggestions made on how to more effectively audit them
CD/Recorded
$0
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Recorded/CD
ISO 27001: The risk assessment, control selection and risk treatment plan

ISO 27001: The risk assessment, control selection and risk treatment plan

  • Speaker: Alan Calder
  • Product ID: 700300
  • Duration: 60 Min
In this Quality compliance training topics will be related to the risk assessment, control selection and risk treatment plan for developing an Information Security Management system that is capable of accredited certification to ISO/IEC 27001:2005. This is a part of a series of webinars that support those considering or developing an Information Security Management system that is capable of accredited certification to ISO/IEC 27001:2005.
CD/Recorded
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Recorded/CD
Internal Audit and Risk Mitigation - Effective and practical use of the COSO and COBiT methodologies

Internal Audit and Risk Mitigation - Effective and practical use of the COSO and COBiT methodologies

  • Speaker: Vic Datta
  • Product ID: 700296
  • Duration: 60 Min
This Internal audit training is to align the audit risk assessment, audit ecosystem, audit plan, and audit engagements with the larger organization’s strategy, vision, and values.
CD/Recorded
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Recorded/CD
How to Manage an FDA Inspection

How to Manage an FDA Inspection

  • Speaker: Susan C Reilly
  • Product ID: 700298
  • Duration: 60 min
This FDA Inspection training is designed to provide the tools and practices necessary to effectively prepare for and manage a successful FDA inspection.
CD/Recorded
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Recorded/CD
Auditing a Process-based System

Auditing a Process-based System

  • Speaker: Dr. Sandford Liebesman
  • Product ID: 700260
  • Duration: 60 Min
This Internal Audit training will provide valuable assistance to organizations desiring to comply with ISO 9001:2000 and will provide the internal audit functions with methodology and tools to better perform internal audits.
CD/Recorded
$0
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Recorded/CD
What Every Firm Should Know About Business Continuity Compliance

What Every Firm Should Know About Business Continuity Compliance

  • Speaker: Henry Theberge
  • Product ID: 700251
  • Duration: 60 Min
This Corporate governance training will provide a basic understanding of business continuity, discuss why business continuity is important, for compliance with rule 466 and others, clarify what to look for during audits.
CD/Recorded
$249
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Recorded/CD
Preparing for an FDA Inspection

Preparing for an FDA Inspection

  • Speaker: Sue Jacobs
  • Product ID: 700250
  • Duration: 60 Min
This FDA Inspection will discuss FDA inspection readiness techniques and how to prepare your organization for a facility inspection.
CD/Recorded
$249
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Recorded/CD
Auditing IT Initiatives- Assessing Implementation

Auditing IT Initiatives- Assessing Implementation

  • Speaker: Dan Swanson
  • Product ID: 700218
  • Duration: 60 Min
In this Auditing IT training learn how to assess an IT initiative’s implementation “preparedness” and how to reduce your IT risk.
CD/Recorded
$249
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Recorded/CD
How to Prepare for an OSHA Inspection

How to Prepare for an OSHA Inspection

  • Speaker: Lourdes Menendez
  • Product ID: 700105
  • Duration: 60 Min
This OSHA Inspection training will guide you through OSHA procedures when they visit a company and what they look for and the main rights and responsibilities employers have with respect to OSHA. This program introduces the basic way OSHA functions. Before you invest money in courses and isolated actions you need to know what OSHA expects from employers and how to comply with their basic requirements.
CD/Recorded
$249
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Recorded/CD
ISO 9001:2000 1st, 2nd and 3rd Party Auditing & Implementation

ISO 9001:2000 1st, 2nd and 3rd Party Auditing & Implementation

  • Speaker: Mark Stevens
  • Product ID: 700060
  • Duration: 60 Min
In this ISO 9001:2000 Training Understand the ISO 9001:2000 standard requirements for 1st, 2nd and 3rd part audits.
CD/Recorded
$249
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Recorded/CD
Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR

Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR

  • Speaker: David Nettleton
  • Product ID: 701687
  • Duration:
This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features and validation (10 step risk based approach).
CD/Recorded
$0
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Recorded/CD
Getting to Know FDA Audit Practices and the 10 Most Common Cited GMP Deficiencies

Getting to Know FDA Audit Practices and the 10 Most Common Cited GMP Deficiencies

  • Speaker: Kenneth Christie
  • Product ID: 703635
  • Duration:
This training program will provide attendees with a better understanding of how the FDA conducts their audits and the areas of most focus. In addition, it provides a summary of common GMP deficiencies given to drug manufacturers, to use to evaluate one’s own practices. Finally, when given a regulatory audit finding, this webinar will review the top five items to remember when submitting your responses to them to avoid further questions.
CD/Recorded
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Recorded/CD
How to Establish an Effective IT Governance, Risk and Compliance (GRC) Framework - Organization and Responsibilities

How to Establish an Effective IT Governance, Risk and Compliance (GRC) Framework - Organization and Responsibilities

  • Speaker: Michael C Redmond
  • Product ID: 704991
  • Duration:
This training program will discuss how to develop a great GRC program that ensures proper governance, risk management and compliance management of all IT systems and processes that support the business operations.
CD/Recorded
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Recorded/CD
Auditing Business Continuity Plans According to ISO 22301

Auditing Business Continuity Plans According to ISO 22301

  • Speaker: Michael C Redmond
  • Product ID: 704410
  • Duration:

This training will cover the best practices for implementing and auditing a Business Continuity Plan. The speaker will discuss the lifecycle of a BCP program with specific emphasis on Risk Assessment and Business Impact Analysis, Designing a living BCP & Testing & Maintenance. The program will also detail the various standards from FFIEC to ISO. Participants will understand what’s involved in a full BCP program and have insights based upon field experience that can be applied to Internal Audit work and BCP. The session will provide you with tools that you can bring back to your company to improve upon BCP programs & ability to audit them to provide targeted recommendations.
CD/Recorded
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Recorded/CD
Annual Analytical Laboratory Data Integrity Training

Annual Analytical Laboratory Data Integrity Training

  • Speaker: Nanda Subbarao
  • Product ID: 705326
  • Duration:
This webinar will address the key elements of regulatory expectations for analytical laboratory data integrity. It will teach best practices to avoid 483s and warning letters issued by FDA related to data integrity issues.
CD/Recorded
$0
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Recorded/CD
Pack of two courses: The essentials of Food and Drug Administration Medical Device Regulations: A primer for manufacturers and suppliers

Pack of two courses: The essentials of Food and Drug Administration Medical Device Regulations: A primer for manufacturers and suppliers

  • Speaker: Edwin L Bills
  • Product ID: 700957
  • Duration:
This pack of 2 courses contains the essentials of FDA Medical Device regulations.
CD/Recorded
$349
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Recorded/CD
Avoiding FDA observations: Do's and Don'ts during Laboratory Inspections

Avoiding FDA observations: Do's and Don'ts during Laboratory Inspections

  • Speaker: Kim Huynh-Ba
  • Product ID: 703278
  • Duration:
This training will provide the attendees best practices for handling FDA inspections to avoid form 483 and Warning Letters.
CD/Recorded
$0
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Recorded/CD
How to Buy COTS Software, and Audit and Validate Vendors

How to Buy COTS Software, and Audit and Validate Vendors

  • Speaker: David Nettleton
  • Product ID: 703820
  • Duration:
This training program will focus on instructing attendees on best practices for buying COTS (Commercial Off-The-Shelf) software and to evaluate a software vendor. It will also highlight key data and systems subject to Part 11, and list requirements for IT, SaaS, and cloud hosting.
CD/Recorded
$0
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Recorded/CD
GMP Requirements for Validation and Re-Validation of Analytical Procedures

GMP Requirements for Validation and Re-Validation of Analytical Procedures

  • Speaker: Kim Huynh-Ba
  • Product ID: 703041
  • Duration:
This webinar will explain the cGMP and ICH validation requirements for analytical procedures and discuss key factors that would affect validation process of analytical procedures. It will review the differences between validation and re-validation plan.
CD/Recorded
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Recorded/CD
Quality Metrics and the Issues with the FDA’s Revision Draft Guidance Quality Metrics Data

Quality Metrics and the Issues with the FDA’s Revision Draft Guidance Quality Metrics Data

  • Speaker: Barry A Friedman
  • Product ID: 705452
  • Duration:
This webinar will discuss the main issues with FDA’s revised draft guidance on submission of quality metrics data. It will also cover the most common observations that the FDA issues within the warning letter and how these can impact your organization.
CD/Recorded
$0
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