ComplianceOnline

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.

Recorded/CD
Mastering OSHA's 2024 Recordkeeping Changes and Beyond

Mastering OSHA's 2024 Recordkeeping Changes and Beyond

  • Speaker: Joe Keenan
  • Product ID: 706964
  • Duration: 60 Min
The audience will take away a basic understanding of what the OSHA Recordkeeping Requirements are and learn to navigate the complexities in filling out the 2024 OSHA Recordkeeping Forms.
CD/Recorded
$249
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
$299
Recorded/CD
Deviation Investigation Best Practices:  Ensuring Correct Content and Conclusions

Deviation Investigation Best Practices: Ensuring Correct Content and Conclusions

  • Speaker: Michael Ferrante
  • Product ID: 703538
  • Duration: 90 min
This webinar will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA. Learn how to identify and avoid potential pitfalls during deviation investigations.
CD/Recorded
$249
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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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