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
Subcontractor auditing (cGMP/Pharma/Med device industries)

Subcontractor auditing (cGMP/Pharma/Med device industries)

  • Speaker: Jan Warner
  • Product ID: 705063
  • Duration: 90 Min
This course will describe the basic principles and requirements for building a supplier audit program. This webinar will provide a framework on which to build your subcontractor auditing program.
CD/Recorded
$0
Recorded/CD
Use of Electronic Health Record Data (EHR) in FDA regulated clinical investigations

Use of Electronic Health Record Data (EHR) in FDA regulated clinical investigations

  • Speaker: Rachelle D Souza
  • Product ID: 704906
  • Duration: 60 Min
This webinar will discuss FDA’s current recommendations on using electronic health records in prospective clinical investigations of human drugs, biologics, medical devices and combination products.
CD/Recorded
$249
Recorded/CD
Effective Discipline and Lawsuit-Proof Termination: How to Remedy Performance and Conduct Problems While Minimizing Your Legal Risks

Effective Discipline and Lawsuit-Proof Termination: How to Remedy Performance and Conduct Problems While Minimizing Your Legal Risks

  • Speaker: Susan Fahey Desmond
  • Product ID: 705058
  • Duration: 90 Min
This training program will elucidate effective documentation techniques. It will discuss what documentation is needed to justify a termination decision and key record retention requirements. Attendees will learn how to fill out a performance appraisal and understand the essentials of a document retention program.
CD/Recorded
$249
Recorded/CD
Implementing a Modern Pharmaceutical Quality System

Implementing a Modern Pharmaceutical Quality System

  • Speaker: Steven Laurenz
  • Product ID: 705055
  • Duration: 60 Min
This presentation explores the basic concepts making up an ICH Q10 Quality System approach and steps to properly implement the concepts.
CD/Recorded
$0
Recorded/CD
Business Email Compromise and Ransomware - Red Flags and Mitigation

Business Email Compromise and Ransomware - Red Flags and Mitigation

  • Speaker: Rayleen M Pirnie
  • Product ID: 705038
  • Duration: 60 Min
The Internet Crime Complaint Center (IC3) reports that U.S. victims alone lost $18 million in 15 months to just a single form of ransomware. This training program will review the risks associated with various types of cyber fraud, and in particular, business email compromise (BEC) and ransomware. The session will also discuss documenting sound business practices to minimize exposure and loss and list what to present to your board of directors before an incident.
CD/Recorded
$179
Recorded/CD
Practical Application of HIPAA Risk Analysis

Practical Application of HIPAA Risk Analysis

  • Speaker: Jim Sheldon-Dean
  • Product ID: 704294
  • Duration: 90 Min
This 90-minute webinar training will look at how to properly conduct a risk analysis. Attendees will learn what safeguards need to be in place, what documentation is required, and what follow-through needs to be done. The course will examine the pros and cons of various available free tools, and in-house versus outsourced reviews.
CD/Recorded
$249
Recorded/CD
AML Risks in Correspondent Banking: What You Need to Know for 2017

AML Risks in Correspondent Banking: What You Need to Know for 2017

  • Speaker: Joe Soniat
  • Product ID: 704997
  • Duration: 60 Min
Correspondent banking has become a hot topic with BSA AML over the past few years. With examination scrutiny on correspondent banking high, this training program will highlight why it is essential to know the risk and what to do when it comes to banking other banks.
CD/Recorded
$279
Recorded/CD
Procurement and Contract Fraud - Detection and Prevention

Procurement and Contract Fraud - Detection and Prevention

  • Speaker: John E Grimes
  • Product ID: 704334
  • Duration: 90 Min
This training program will examine the fraud vulnerabilities in the procurement of materials and services in the private sector. In addition, it will explore the many procurement and contract fraud schemes and at what point in the procurement and contract process they occur.
CD/Recorded
$179
Recorded/CD
Investment Performance Risk - Deep Dive into Leverage

Investment Performance Risk - Deep Dive into Leverage

  • Speaker: Robert Geary
  • Product ID: 704811
  • Duration: 60 Min
This training program will provide an in depth understanding of the management of investment performance risk as an individual investor and in the investment relationship of a money manager. Participants will learn to fully recognize and evaluate the use of leverage and establish the appropriateness of leverage in a portfolio or a single investment.
CD/Recorded
$0
Recorded/CD
Audits - Seven reasons they don't work

Audits - Seven reasons they don't work

  • Speaker: Susanne Manz
  • Product ID: 705042
  • Duration: 90 Min
Continuous Improvement starts with awareness of issues and opportunities. And without an effective internal audit program, management lacks awareness of the issues within their quality system. Management is blind to the gaps in the quality system and the risk that poses for the company. Even worse, management is blind to the impact on product quality and risk to the customer. This webinar will highlight red-flags and ways reduce compliance and quality risk.
CD/Recorded
$0
Recorded/CD
Phase I First-in-Man Studies: What is Special About How and Where These Trials are Conducted?

Phase I First-in-Man Studies: What is Special About How and Where These Trials are Conducted?

  • Speaker: Charles H Pierce
  • Product ID: 704842
  • Duration: 90 Min
This webinar will discuss the expectations of Phase 1 'First-in-Man' clinical studies, contrast the testing of pharmacokinetics and pharmacodynamics, differentiate safety testing in Phase 1 and 3 and describe the process of establishing the starting dose.
CD/Recorded
$50
Recorded/CD
The Department of Labor's Fiduciary the New Final Rule - Best Practices for Conducting a Due Diligence and Reviewing the Best Interest Contract Exemption

The Department of Labor's Fiduciary the New Final Rule - Best Practices for Conducting a Due Diligence and Reviewing the Best Interest Contract Exemption

  • Speaker: Lisa Marsden
  • Product ID: 705021
  • Duration: 60 Min
This 60-minute training session will provide a detailed overview of the Department of Labor’s Final Fiduciary Rule including the history and on-going resistance to the rule. The session will delve into details on how the rule was established and who it will be applied to. The webinar instructor will discuss the summary of the details of the new final rule and what firms must do to comply.
CD/Recorded
$179
Recorded/CD
Compliance with the New EU Clinical Trial Regulation

Compliance with the New EU Clinical Trial Regulation

  • Speaker: Laura Brown
  • Product ID: 705007
  • Duration: 60 Min
This webinar will provide an essential understanding to help with compliance with the new regulation and associated implementing acts and other texts for carrying out clinical trials in the EU.
CD/Recorded
$0
Recorded/CD
How to Manage Reputational Risk

How to Manage Reputational Risk

  • Speaker: Mario Mosse
  • Product ID: 705012
  • Duration: 90 Min
Reputation risk is the risk of loss resulting from damages to a firm's reputation, in lost revenue; increased operating, capital or regulatory costs; or destruction of shareholder value, due to an adverse or potentially criminal event even if the company is not found guilty. This training program will explore the hidden danger behind reputational risk that can pose a threat to the survival of the biggest and best-run companies, often wiping out millions or billions of dollars in market capitalization or future revenues and occasionally resulting in a change at the uppermost levels of management.
CD/Recorded
$179
Recorded/CD
The Overall Annual Compliance Review - Latest Advisers Act

The Overall Annual Compliance Review - Latest Advisers Act

  • Speaker: Lisa Marsden
  • Product ID: 705016
  • Duration: 60 Min
This webinar will focus on compliance requirements to prevent violations of the Advisers Act. The training program will also discuss how to design your firm’s annual review and effectively manage the review process.
CD/Recorded
$0
Recorded/CD
Cyber Security Risk Assessment

Cyber Security Risk Assessment

  • Speaker: Michael C Redmond
  • Product ID: 704523
  • Duration: 60 Min
This training program will examine strategic planning to prepare and review your cyber and information security risks, cyber risks and impact analysis, IT outsourcing, and other underlying risks. The program will help attendees identify, analyze and document the events and environmental surroundings that can adversely affect an organization.
CD/Recorded
$249
Recorded/CD
Why I should test raw materials for microbial presence and what is the microbiological and business risk if I choose not to?

Why I should test raw materials for microbial presence and what is the microbiological and business risk if I choose not to?

  • Speaker: Henry Urbach
  • Product ID: 703058
  • Duration: 90 Min
This webinar on biopharmaceutical raw material testing will discuss how to implement processes for the control of microbial contamination, establish microbial limits and mitigate the risk of contamination.
CD/Recorded
$199
Recorded/CD
Navigating the variations in state food regulatory structure

Navigating the variations in state food regulatory structure

  • Speaker: Darin Detwiler
  • Product ID: 705006
  • Duration: 90 Min
This course is designed to bring food industry leaders up to speed with the latest research in states’ food regulatory characteristics. The goal is to enable industry leaders to better understand and navigate through the state-by-state nuances.
CD/Recorded
$0
Recorded/CD
Compliance with the New ICH GCP revised 2 Guidelines

Compliance with the New ICH GCP revised 2 Guidelines

  • Speaker: Laura Brown
  • Product ID: 704989
  • Duration: 60 Min
This New ICH GCP E6 Revision 2 changes will cover those new requirements for running clinical trials, evaluate the changes and discuss how to implement these for sponsors, CROs and study sites. This session will enable you to meet the new international GCP standard to ensure the acceptance of clinical trial data by the regulatory authorities internationally including the European Union (EU), Japan, the United States, Canada and Switzerland.
CD/Recorded
$0
Recorded/CD
Creating a Good Design History File (DHF) for Audit Success

Creating a Good Design History File (DHF) for Audit Success

  • Speaker: Mercedes Massana
  • Product ID: 701978
  • Duration: 60 Min
This DHF regulatory compliance training will discuss the structure of a good Design History File, elements to look for when auditing a DHF and how to address issues. It will provide the information necessary to maintain a good DHF that will help manufacturers during a regulatory compliance audit.
CD/Recorded
$279
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