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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
Creating Proper User Requirement Specifications (URS) for Computer Systems Validation (CSV) - Ensuring Overall Regulatory Compliance

Creating Proper User Requirement Specifications (URS) for Computer Systems Validation (CSV) - Ensuring Overall Regulatory Compliance

  • Speaker: Gaurav Walia
  • Product ID: 704370
  • Duration: 75 Min
This training program will provide attendees with the ultimate set of tools in order to help their firms properly create User Requirement Specifications (URS) for Computer Systems Validation (CSV) with emphasis on current industry trends in this particular area as well as current Food and Drug Administration (FDA) regulatory trends and enforcement activity.
CD/Recorded
$229
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Recorded/CD
How to Spot a Potentially Violent Worker in the Workplace: Protect Your Workforce

How to Spot a Potentially Violent Worker in the Workplace: Protect Your Workforce

  • Speaker: Vanessa G Nelson
  • Product ID: 704374
  • Duration: 60 Min
This training program on reducing and preventing workplace violence hazards will train attendees on spotting a potentially violent worker in the workplace. It will also enumerate OSHA requirements regarding violence in the workplace and discuss employer’s responsibilities and industry trends for workplace violence.
CD/Recorded
$149
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Recorded/CD
Accounts Receivable - Collection Techniques

Accounts Receivable - Collection Techniques

  • Speaker: Brian Shanahan
  • Product ID: 704279
  • Duration: 90 Min
This training program will help attendees discover the importance of segmenting accounts based on size and payment behavior and then using the right collection technique with the right customers. The course will also offer an understanding of the best practices that should be deployed around each of these collection techniques.
CD/Recorded
$149
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Recorded/CD
FDA Inspection Lessons Learned: Lack of Trial Oversight

FDA Inspection Lessons Learned: Lack of Trial Oversight

  • Speaker: Janet Ellen Holwell
  • Product ID: 704263
  • Duration: 90 Min
This training program will critically assess the number of major and critical 2012 inspection findings related to trial oversight. Attendees will learn to identify regulatory requirements for appropriate delegation of duties and investigator oversight.
CD/Recorded
$50
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Recorded/CD
California and Federal Requirements for Paid Sick Leave - Conflicts and Jurisdiction

California and Federal Requirements for Paid Sick Leave - Conflicts and Jurisdiction

  • Speaker: Cathleen M. Hampton
  • Product ID: 704363
  • Duration: 90 Min
This training program will provide an overview of the key intent for establishing paid sick leave programs and policies. It will also discuss the finer points of California law and how that relates to trends spotted all across America.
CD/Recorded
$149
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Recorded/CD
How to Properly Monitor Process and Performance of Pharmaceutical Solid Dosage Equipment

How to Properly Monitor Process and Performance of Pharmaceutical Solid Dosage Equipment

  • Speaker: Michael Levin
  • Product ID: 704274
  • Duration: 60 Min
Among other key topics, this training program will focus on what can be monitored in mixing operations, wet granulation operations, dry granulation operations, compaction operations, and coating operations.
CD/Recorded
$229
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Recorded/CD
Preparing for FDA's Unique Device Identification Rule

Preparing for FDA's Unique Device Identification Rule

  • Speaker: Daniel O Leary
  • Product ID: 702594
  • Duration: 90 Min
This 90-minute webinar will review FDA's draft regulations for UDI and describe the new requirements for labeling medical devices. It covers the new regulations in 21 CFR Part 830, the changes to Part 820, the Quality System Regulation; Part 801, Labeling; Part 803, Medical Device Reporting; Part 806 Corrections and Removals; and other regulations.
CD/Recorded
$229
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Recorded/CD
Out in the Open: Protecting Your Privacy and Identity in the Digital Age on the Internet

Out in the Open: Protecting Your Privacy and Identity in the Digital Age on the Internet

  • Speaker: Joseph Rosner
  • Product ID: 704256
  • Duration: 60 Min
This privacy protection in the digital age training program will detail what the Internet of Things is and how it collects data and tracks you. It will further examine the risks attached to personal information and more.
CD/Recorded
$0
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Recorded/CD
Vendor Management - Building a Strong Questionnaire

Vendor Management - Building a Strong Questionnaire

  • Speaker: Michael D King
  • Product ID: 704119
  • Duration: 60 Min
This training program will highlight why a vendor questionnaire is the keystone your vendor management program is built on. The course will help ensure attendees get the whole picture and determine appropriate controls for information security and privacy.
CD/Recorded
$0
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Recorded/CD
ISO/IEC 27001:2013 - Breaking It Down to Understand and Implement

ISO/IEC 27001:2013 - Breaking It Down to Understand and Implement

  • Speaker: Michael C Redmond
  • Product ID: 703977
  • Duration: 90 Min
This training program will guide attendees in implementing and complying with the requirements of ISO 27001:2013. ISO 27001 is an international standard published by the International Standardization Organization (ISO), and it describes how to manage information security in a company. The latest revision of this standard was published in 2013, and its full title now is ISO/IEC 27001:2013.
CD/Recorded
$0
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Recorded/CD
Employee Discharge and Documentation: Using Documentation to Control the Employment Relationship

Employee Discharge and Documentation: Using Documentation to Control the Employment Relationship

  • Speaker: Douglas Pilarski
  • Product ID: 704036
  • Duration: 120 Min
This webinar will help managers establish best practices for managing their workforce using sound performance management techniques, especially documentation of poor job performance and code of conduct violations to best support terminations. Learn how HR can coach their executives and managers on how best to work through their performance management strategy.
CD/Recorded
$349
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Recorded/CD
Internal Quality Audit: Identifying Corrective and Preventive Actions

Internal Quality Audit: Identifying Corrective and Preventive Actions

  • Speaker: Ronald Schoengold
  • Product ID: 700585
  • Duration: 75 Min
This Internal Quality Audit training is presented as a practical way for an organization to evaluate its internal audit program and make required improvements.
CD/Recorded
$229
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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
Managing Corporate Risks with ISO 31000

Managing Corporate Risks with ISO 31000

  • Speaker: Kelly Eisenhardt
  • Product ID: 705083
  • Duration: 60 Min
ISO 31000 is a standard developed by the International Organization for Standardization (ISO) which provides a basic guideline and principles for the application of risk management. Companies that use risk management processes vary across industries in scope and magnitude and address a wide variety of challenges. This training program will offer an in depth look into the key components of the ISO 31000 guideline and best practices to implement and support a corporate risk management strategy or program.
CD/Recorded
$0
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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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