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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
Audit/Inspection Preparedness for Clinical Research/Site Coordinators

Audit/Inspection Preparedness for Clinical Research/Site Coordinators

  • Speaker: Ornat katzir
  • Product ID: 702248
  • Duration: 60 Min
This webinar on clinical site audit/ inspection will outline the responsibilities of the Investigator and the clinical research coordinator during and after site audits/inspections and show what you must do to ensure preparedness at all times.
CD/Recorded
$149
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Recorded/CD
Clinical Trial auditing - Identifying risks and building a more compliant and successful trial

Clinical Trial auditing - Identifying risks and building a more compliant and successful trial

  • Speaker: Peter Calcott
  • Product ID: 701214
  • Duration: 90 Min
This Clinical trial auditing training will provide valuable assistance how to conduct clinical trials both using internal resources and also those that outsource the function to CRO’s in pharmaceutical and biotech industries. How to assure your clinical trials are in compliance and meet the agencies requirements.
CD/Recorded
$249
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Recorded/CD
Best Practices for Writing an Effective SOP to Lead to Successful FDA Inspections

Best Practices for Writing an Effective SOP to Lead to Successful FDA Inspections

  • Speaker: Glen Feye
  • Product ID: 700375
  • Duration: 63 Mins
This SOP best practices webinar will show how to create “state of the art” SOP or review your current SOP so as to successfully manage FDA Investigators and other Regulatory Authorities Audits which can help improve and influence Audit Outcomes.
CD/Recorded
$149
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Recorded/CD
Critical Role of Quality Audit in GxP Compliance & Improvement

Critical Role of Quality Audit in GxP Compliance & Improvement

  • Speaker: David Dills
  • Product ID: 700982
  • Duration: 62 Min
This Webinar will address the key elements on being an effective auditor for your company covering the different types of audits, what do audits measure and how are audit results measured and certainly why perform audits to begin with. Learn the basic skills required and how to apply them and the knowledge in becoming more effective.
CD/Recorded
$299
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Recorded/CD
Conducting Successful Product Complaint Investigations

Conducting Successful Product Complaint Investigations

  • Speaker: David Dills
  • Product ID: 700909
  • Duration: 85 Min
The regulatory expectations for both pharmaceuticals and medical devices will be emphasized as well as overview of best practices for timely and effective investigations. This webinar will provide valuable assistance and guidance to the life sciences manufacturers engaged in various aspects of product complaint investigations.
CD/Recorded
$299
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Recorded/CD
How to successfully audit software systems, and thereby avoid having FDA write software-related 483's and warning letters

How to successfully audit software systems, and thereby avoid having FDA write software-related 483's and warning letters

  • Speaker: Dennis Moore
  • Product ID: 700221
  • Duration: 60 Min
This Software Auditing Procedure training will discussion on FDA software Standard “General Principles of Software Validation”, Actual FDA investigator software auditing techniques for software failure investigations.
CD/Recorded
$299
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Recorded/CD
What will FDA expect and request from your firm during Design Control portions of Inspections?

What will FDA expect and request from your firm during Design Control portions of Inspections?

  • Speaker: Dennis Moore
  • Product ID: 700159
  • Duration: 60 Min
This Design Control Inspection training will review of the sections of Quality system regulations, design control regulations which FDA uses as an inspection tool. Actual FDA investigator training methods related to design control inspections. Real life examples of FDA design control compliance issues will be examined.
CD/Recorded
$299
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Recorded/CD
EFFECTIVE INVESTIGATIONS What to Do When the Unexpected Happens! - Proper Investigation of Quality Events

EFFECTIVE INVESTIGATIONS What to Do When the Unexpected Happens! - Proper Investigation of Quality Events

  • Speaker: Michael Anisfeld
  • Product ID: 701204
  • Duration: 70 Min
This Quality inspection training will teaches tools and techniques that can be employed to get to the “root cause” of unexpected quality events, and to resolve them in a manner such that they stay resolved in a GMP compliant manner.
CD/Recorded
$0
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Recorded/CD
Understanding and Preparing for System Based Inspections: Laboratory Control System

Understanding and Preparing for System Based Inspections: Laboratory Control System

  • Speaker: Robert Ferer
  • Product ID: 701336
  • Duration: 60 Min
This system based inspection for Laboratory Control System training/webinar includes measures and activities related to laboratory procedures, testing, analytical methods development and validation or verification, and the stability program.
CD/Recorded
$99
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Recorded/CD
Understanding and Preparing for System Based Inspections: Facilities and Equipment System

Understanding and Preparing for System Based Inspections: Facilities and Equipment System

  • Speaker: Robert Ferer
  • Product ID: 701332
  • Duration: 90 Min
This FDA Inspection training will provide you an understanding of how the FDA conducts systems based inspections, and will review examples of FDA 483 observations, so you can better prepare for your PAI.
CD/Recorded
$50
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Recorded/CD
Preparing and Executing Medical Device Quality Audits: How to Meet the FDA's Expectations

Preparing and Executing Medical Device Quality Audits: How to Meet the FDA's Expectations

  • Speaker: Edwin L Bills
  • Product ID: 701310
  • Duration: 90 Min
This Medical device quality audits training review the process used by FDA to perform inspections of medical device manufacturers and will provide advice for quality and regulatory personnel that required providing information to an FDA inspector.
CD/Recorded
$299
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Recorded/CD
Auditing Analytical Laboratories for FDA Compliance

Auditing Analytical Laboratories for FDA Compliance

  • Speaker: Michelle Sceppa
  • Product ID: 701325
  • Duration: 60 Min
This Analytical laboratory audit training/webinar will show how to implement a GXP program and how to audit this program.
CD/Recorded
$199
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Recorded/CD
Monitoring High Risk Transactions

Monitoring High Risk Transactions

  • Speaker: Doug Keipper
  • Product ID: 703001
  • Duration: 60 Min
This BSA/AML (Bank Secrecy Act/ Anti Money Laundering) compliance training will help attendees understand, identify and mitigate the risks associated with high risk transactions.
CD/Recorded
$0
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Recorded/CD
Development and Audit of Complaint Handling and MDR Processes

Development and Audit of Complaint Handling and MDR Processes

  • Speaker: Jeff Kasoff
  • Product ID: 701287
  • Duration: 60 Min
This Medical device training will include the requirements for defining, documenting, and implementing a complaint-handling system, including the requirements for complaint review, investigation, and corrective action.
CD/Recorded
$0
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Recorded/CD
W-2 and W-4 Update and Best Practices

W-2 and W-4 Update and Best Practices

  • Speaker: Miles Hutchinson
  • Product ID: 704333
  • Duration: 90 Min
This webinar will prepare your staff for this filing year, improve your employee reporting set-up and maintenance practices, and reduce your risk of complaints from the IRS. Learn the latest updates on Form W-4 and Form W-2 wage and withholding reporting.
CD/Recorded
$0
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Recorded/CD
How to Prepare for, Manage, and Follow-up to an FDA Inspection

How to Prepare for, Manage, and Follow-up to an FDA Inspection

  • Speaker: Jeff Kasoff
  • Product ID: 701236
  • Duration: 60 Min
This FDA inspection training 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.
CD/Recorded
$299
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Recorded/CD
Preparing for Regulatory Audits

Preparing for Regulatory Audits

  • Speaker: Nick Campbell
  • Product ID: 701170
  • Duration: 60 Min
In this FDA audit & Inspection training we will focus on ideas that will help identify areas of improvement before the formal inspection occurs. Further, you will learn techniques that will enhance your effectiveness during the audit execution.
CD/Recorded
$199
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Recorded/CD
Auditing for Microbiological Aspects of Pharmaceutical and Biopharmaceutical Manufacturing

Auditing for Microbiological Aspects of Pharmaceutical and Biopharmaceutical Manufacturing

  • Speaker: Frank Settineri
  • Product ID: 701186
  • Duration: 90 Min
This Pharmaceutical compliance training will outline actions to take to ensure the microbiological wellness of your facility and will introduce the concept of "Thinking like a Bug".
CD/Recorded
$199
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Recorded/CD
How to perform effective supplier audits, and avoid FDA 483

How to perform effective supplier audits, and avoid FDA 483

  • Speaker: Dennis Moore
  • Product ID: 701193
  • Duration: 60 Min
This FDA audit & inspection training will provide your firm with key insights on how to perform superior supplier audits. It will help you uncover purchasing controls GMP violations.
CD/Recorded
$149
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Recorded/CD
Rules of Practice (FSIS) 9CFR part 500

Rules of Practice (FSIS) 9CFR part 500

  • Speaker: John Miller
  • Product ID: 701172
  • Duration:
This Food Safety and Inspection Service (FSIS) training will guide you through the different levels of enforcement that FSIS utilizes.
CD/Recorded
$199
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