ComplianceOnline

Quality Assurance and Quality Controls Training - Live Webinars, Recordings & CDs

Whether you are a quality assurance or a quality control professional, you know how the rapid transformations in regulatory requirements and technology are changing the nature of your work. We understand this challenge and have put together quality assurance and quality control courses to help you make your role robust-proof. Browse for the many courses, standards, and tools of specific interest to you.

Recorded/CD
Do you understand the FDA Guidance "Recognition and Use of Consensus Standards"?

Do you understand the FDA Guidance "Recognition and Use of Consensus Standards"?

  • Speaker: Cheryl Wagoner
  • Product ID: 703584
  • Duration: 60 Min
This FDA compliance webinar will discuss in detail the guidance on recognition and use of consensus standards. It will focus on the topics such as voluntary conformance, declaration review and content of declaration of conformity.
CD/Recorded
$229
Recorded/CD
Current Good Manufacturing Practices (cGMPs)

Current Good Manufacturing Practices (cGMPs)

  • Speaker: Philip Russ
  • Product ID: 703558
  • Duration: 120 Min
This webinar will cover in detail the current Good Manufacturing Practices (cGMPs) regulations for pharmaceutical products. Attendees will learn how to comply with these FDA regulations and avoid pitfalls.
CD/Recorded
$249
Recorded/CD
Qualification Sample Size and Statistical Confidence for Pharma Process Performance Qualification (PPQ)

Qualification Sample Size and Statistical Confidence for Pharma Process Performance Qualification (PPQ)

  • Speaker: Marvin Iglehart
  • Product ID: 703579
  • Duration: 90 Min
This webinar will discuss the requirements and general expectations for Stage 2 – Process Qualification, the key concepts that lead to the basis of confidence level and/or statistical confidence and how to apply the concepts in practical use for validation, including acceptance criterion.
CD/Recorded
$229
Recorded/CD
Food Contact Notification (FCN) - Obtaining New Regulations from FDA on Your Terms

Food Contact Notification (FCN) - Obtaining New Regulations from FDA on Your Terms

  • Speaker: Jeffrey Scott Eberhard
  • Product ID: 703572
  • Duration: 60 Min
This food safety webinar will explain how to thoroughly review a food contact substance, determine its regulatory status and obtain a new regulation from FDA via the FCN process for a substance that does not meet suitable regulatory status.
CD/Recorded
$229
Recorded/CD
Simplifying the Dietary Supplement cGMPs for Those Confused by the Regulations

Simplifying the Dietary Supplement cGMPs for Those Confused by the Regulations

  • Speaker: Jennifer Medlar
  • Product ID: 703559
  • Duration: 60 Min
This webinar will explain cGMP regulations for dietary supplements. It will provide an overview of key requirements for dietary supplements including written procedures and records required by cGMP. Attendees will learn best practices to comply with these regulations.
CD/Recorded
$229
Recorded/CD
Quality System Development: Strength, Compliance and Efficiency through Value Stream Mapping

Quality System Development: Strength, Compliance and Efficiency through Value Stream Mapping

  • Speaker: Philip Russ
  • Product ID: 703490
  • Duration: 60 Min
This webinar will explain the principles of lean and value stream mapping. Attendees will learn how to apply lean concepts to continuous improvement work across the quality system.
CD/Recorded
$229
Recorded/CD
Batch Production Record (BPR) and Device History Record (DHR) Review and Quality Assessment

Batch Production Record (BPR) and Device History Record (DHR) Review and Quality Assessment

  • Speaker: Jerry Dalfors
  • Product ID: 703560
  • Duration: 90 Min
This webinar will provide the typical elements required to be included in the Batch Production Record and the Device History Record in order to accomplish a quality and cost effective review and quality assessment based on current regulatory expectations.
CD/Recorded
$229
Recorded/CD
ISO 22000 vs GFSI (SQF, BRC, IFS, and FSSC 22000): Meeting key Requirements

ISO 22000 vs GFSI (SQF, BRC, IFS, and FSSC 22000): Meeting key Requirements

  • Speaker: Mark Kruk
  • Product ID: 703557
  • Duration: 60 Min
This webinar will focus on ISO 22000 Food Safety Management System and its comparison to the Global Food Safety Initiative (GFSI) Standard. It will provide an overview of key requirements and will discuss differences and similarities between both the approaches. It will also address key strategic business factors to consider when selecting a particular approach.
CD/Recorded
$229
Recorded/CD
Steps to Design and Develop an Effective Closed Loop Change Control System

Steps to Design and Develop an Effective Closed Loop Change Control System

  • Speaker: Michael Kagan
  • Product ID: 703489
  • Duration: 90 Min
This webinar will discuss how to design an effective change control system – electronic as well as paper-based – with traceability and closed loop verification built into the process.
CD/Recorded
$229
Recorded/CD
Current Issues in the Regulation of Dietary Supplements

Current Issues in the Regulation of Dietary Supplements

  • Speaker: Eric B Alspaugh
  • Product ID: 703556
  • Duration: 90 Min
This webinar will explain FDA regulations and current good manufacturing practices (cGMPs) for dietary supplements. Attendees will learn how to comply with these regulations and avoid enforcement actions.
CD/Recorded
$229
Recorded/CD
Current Trends in FDA Inspections

Current Trends in FDA Inspections

  • Speaker: Michael Ferrante
  • Product ID: 703485
  • Duration: 90 Min
This webinar will focus on the current trends in FDA inspections and guidelines that can be implemented to ensure compliance with the latest quality and regulatory requirements. Attendees will learn how to prepare for an FDA inspection to avoid Warning Letters.
CD/Recorded
$229
Recorded/CD
Supplier Qualification Audit, A Risk Based Approach

Supplier Qualification Audit, A Risk Based Approach

  • Speaker: Yasamin Ameri
  • Product ID: 703477
  • Duration: 60 Min
This webinar will discuss requirements for supplier and vendor qualifications. Attendees will learn how to develop a risk management plan for monitoring of suppliers, vendors and service providers. It will also discuss how to prevent recalls and advisory notices due to provided non-conforming materials or bad services.
CD/Recorded
$229
Recorded/CD
Internal Auditing in Pharmaceutical Manufacturing - Lightning Rod & Steam Valve

Internal Auditing in Pharmaceutical Manufacturing - Lightning Rod & Steam Valve

  • Speaker: Mitchell Ehrlich
  • Product ID: 703465
  • Duration: 60 Min
This webinar will explain how to conduct an effective internal audit program. Attendees will learn the benefits of a well-designed and executed internal auditing program for GMP compliance enhancement, management informatics and for avoidance of whistleblower actions.
CD/Recorded
$229
Recorded/CD
Dual and Third-Country Nationals: Ensuring Foreign Licensee Requirements to Prevent Diversion of ITAR-Controlled Defense Articles

Dual and Third-Country Nationals: Ensuring Foreign Licensee Requirements to Prevent Diversion of ITAR-Controlled Defense Articles

  • Speaker: Darrell Coleman
  • Product ID: 703454
  • Duration: 70 Min
This webinar will explain the requirements of ITAR 126.18 regarding the transfer of defense articles (including technical data) to dual and third-country nationals employed by approved foreign end-users. Attendees will learn how to ensure compliance with the ITAR and avoid violations and penalties.
CD/Recorded
$149
Recorded/CD
Equipment Requalification: What and When it is Really Required?

Equipment Requalification: What and When it is Really Required?

  • Speaker: Jennifer Medlar
  • Product ID: 703450
  • Duration: 60 Min
This webinar will explain how to generate a practical and compliant methodology to handle equipment requalification. Attendees will learn about common pitfalls to avoid when requalifying equipment.
CD/Recorded
$229
Recorded/CD
Regulatory Records Primer:  Decoding the Requirements for Medical Device and Pharmaceutical Manufacturers

Regulatory Records Primer: Decoding the Requirements for Medical Device and Pharmaceutical Manufacturers

  • Speaker: Les Schnoll
  • Product ID: 703433
  • Duration: 90 Min
This webinar will explain FDA regulatory records requirements for medical devices and finished pharmaceuticals. It will cover statutory requirement, required content, format, purpose, retention, and structure for regulatory records for both medical devices and pharmaceuticals.
CD/Recorded
$50
Recorded/CD
How to respond to GXP (GCP, GLP, GMP, GPV) Inspection and Audit Findings using Correction and Preventative Action (CAPA)

How to respond to GXP (GCP, GLP, GMP, GPV) Inspection and Audit Findings using Correction and Preventative Action (CAPA)

  • Speaker: Laura Brown
  • Product ID: 703160
  • Duration: 60 Min
This webinar will help attendees understand how to respond to inspection and audit findings using CAPA (Correction and Preventative Action) for all types of GXP inspections and audit (eg GCP, GLP, GMP, GPV).
CD/Recorded
$229
Recorded/CD
Understanding ISO 13485 vs. ISO 9001 for Successful QMS in Medical Device Industries

Understanding ISO 13485 vs. ISO 9001 for Successful QMS in Medical Device Industries

  • Speaker: John Chapman
  • Product ID: 701003
  • Duration: 60 Min
This presentation will help you to understand ISO 13485 and implement a successful quality management system, comparing it to ISO 9001 and FDA & European Union requirements. ISO 13485:2003 is a quality management system standard specially written for the medical device industry and is on the U S Food & Drug Administration (FDA) list of recognized consensus standards. Medical device firms certified to ISO 13485:2003 will find themselves very closely compliant with FDA’s Quality System Requirements under 21CFR 820. This presentation will help you to understand ISO 13485 and implement a successful quality management system, comparing it to ISO 9001 and FDA & European Union requirements.
CD/Recorded
$229
Recorded/CD
Food Safety and Continual Improvement: Beyond Corrections and Audits

Food Safety and Continual Improvement: Beyond Corrections and Audits

  • Speaker: Oscar Rodriguez Gonzalez
  • Product ID: 703361
  • Duration: 60 Min
This webinar will present a proactive approach to improve food safety management systems that go beyond corrective actions to deviations and findings from external audits. It will focus on the continual improvement methodologies to speed up or optimize processes, solve problems and manage complexity.
CD/Recorded
$229
Recorded/CD
Mobile Medical Applications: Software Regulatory Requirements

Mobile Medical Applications: Software Regulatory Requirements

  • Speaker: Tim Stein
  • Product ID: 702812
  • Duration: 90 Min
This mobile medical apps training will outline the regulatory requirements for medical device software development processes, and the requirements for submissions.
CD/Recorded
$349
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