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Home › Online Training ›  QA/QC

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.
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Recorded/CD
Supplier Quality Management: Implement it Now or Pay for it Later

Supplier Quality Management: Implement it Now or Pay for it Later

  • Speaker: Les Schnoll
  • Product ID: 703357
  • Duration: 90 Min
This webinar will discuss FDA's requirements for medical device supplier management and the controls you need to have in place to ensure compliance with quality. It will cover how to structure a supplier quality agreement and the tools and methods you need for evaluating and assessing suppliers.
CD/Recorded
$229
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Recorded/CD
Are you prepared for a regulatory audit from FDA or any other regulatory body?

Are you prepared for a regulatory audit from FDA or any other regulatory body?

  • Speaker: Philip Russ
  • Product ID: 703355
  • Duration: 90 Min
This FDA audit training provides an overview of the audit readiness process from internal evaluation of your quality systems to the logistics of the audit itself; with key emphasis placed on equipping you and your team with the skills needed to present expert testimony during interviews with regulators.
CD/Recorded
$229
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Recorded/CD
Understanding and Interpreting the EMA Reflection Paper on GCP Compliance in Relation to Trial Master Files (paper and/or electronic) for Management, Audit and Inspection of Clinical Trials

Understanding and Interpreting the EMA Reflection Paper on GCP Compliance in Relation to Trial Master Files (paper and/or electronic) for Management, Audit and Inspection of Clinical Trials

  • Speaker: Eldin Rammell
  • Product ID: 703281
  • Duration: 60 Min
This training will give attendees an insight into the interpretation of GCP regulations by the European Medicines Agency (EMA) as they relate to the management of trial documents, focusing especially on clarification within the paper on disputed and ambiguous areas of trial master file (TMF) management.
CD/Recorded
$229
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Recorded/CD
How To Translate Academic and Discovery Assays Into GLP Compliant Assays

How To Translate Academic and Discovery Assays Into GLP Compliant Assays

  • Speaker: Todd Graham
  • Product ID: 703275
  • Duration: 60 Min
This GLP compliant assay training will help attendees deal with the challenges and pitfalls that may occur when translating assays as demonstrated in the scientific literature or through internal discovery efforts.
CD/Recorded
$229
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Recorded/CD
Quality Control for Microbiological Media and Reagents

Quality Control for Microbiological Media and Reagents

  • Speaker: Michael Brodsky
  • Product ID: 703233
  • Duration: 60 Min
The webinar will discuss best QC practices and procedures for verifying the suitability and performance characteristics of microbiological media and reagents.
CD/Recorded
$179
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Recorded/CD
Driving Quality and Compliance in Drug Development Through the FDA End-of-Phase 2A Meeting

Driving Quality and Compliance in Drug Development Through the FDA End-of-Phase 2A Meeting

  • Speaker: Roger Toothaker
  • Product ID: 703214
  • Duration: 60 Min
This training on FDA compliance will provide the attendees with an understanding of FDA expectations regarding end-of-phase 2A meeting guidance. Attendees will learn the best practices to comply with the intent of the guidance and to achieve a higher quality outcome from the meeting.
CD/Recorded
$229
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Recorded/CD
Essentials of the Trial Master File for Pharmaceutical, Biotech, Medical Device and Diagnostics Industries and Paper vs. Electronic TMFs - Which is Correct for My Program

Essentials of the Trial Master File for Pharmaceutical, Biotech, Medical Device and Diagnostics Industries and Paper vs. Electronic TMFs - Which is Correct for My Program

  • Speaker: Adam Ruskin
  • Product ID: 703210
  • Duration: 90 Min
This training on clinical compliance will focus on the requirements of trial master file (TMF) for pharmaceutical product, biotech, a medical device or a diagnostic product. Attendees will learn the best practices to ensure that the TMF is ready for inspection by the regulatory authority.
CD/Recorded
$229
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Recorded/CD
US FDA 510(k): Best Practices for 510(k) Preparation and Submission

US FDA 510(k): Best Practices for 510(k) Preparation and Submission

  • Speaker: David Lim
  • Product ID: 703218
  • Duration: 60 Min
This webinar will discuss best practices for premarket notification [510(k)] preparation and submission compliant with FDA's eCopy and Refuse to Accept (RTA) Policy requirements.
CD/Recorded
$229
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Recorded/CD
Bacterial Contamination in a Product Facility

Bacterial Contamination in a Product Facility

  • Speaker: Richard Anfuso
  • Product ID: 703217
  • Duration: 60 Min
This training on food safety compliance will provide the attendees with the knowledge of how food borne pathogens enter a food plant, expand its presence within the facility and contaminate the products. Attendees will learn the best practices for minimizing the presence of these pathogens in the food plant.
CD/Recorded
$149
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Recorded/CD
Drug Master Files: New Requirements under GDUFA

Drug Master Files: New Requirements under GDUFA

  • Speaker: Camille Davis Thornton
  • Product ID: 703209
  • Duration: 60 Min
This training on Generic Drug User Fee Amendments of 2012 will discuss the new requirements under GDUFA and effect of GDUFA on the Drug Master File (DMF) process.
CD/Recorded
$229
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Recorded/CD
FSMA Update - Overview Three Sweeping Rules: Foreign Supplier Verification Program Rule, Third Party Auditor Accreditation Rule, Preventive Controls Rule and GMPs for Animal Food/Feed Rule

FSMA Update - Overview Three Sweeping Rules: Foreign Supplier Verification Program Rule, Third Party Auditor Accreditation Rule, Preventive Controls Rule and GMPs for Animal Food/Feed Rule

  • Speaker: Marc Sanchez
  • Product ID: 703193
  • Duration: 60 Min
This webinar will cover the basic mechanics of new rules under the Food Safety Modernization Act (FSMA); Foreign Supplier Verification Program rule, Third Party Auditor Accreditation rule, Preventive Controls rule and GMPs for Animal Food/Feed rule.
CD/Recorded
$229
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Recorded/CD
Supplier Quality Agreements for Medical Devices

Supplier Quality Agreements for Medical Devices

  • Speaker: Dan OLeary
  • Product ID: 702848
  • Duration: 90 Min
This training on medical device supplier management will explain the elements of a supplier quality agreement and discuss practical steps for implementation.
CD/Recorded
$229
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Recorded/CD
FDA Regulation in Pharmacy Compounding - Risks and Critical Issues to Consider

FDA Regulation in Pharmacy Compounding - Risks and Critical Issues to Consider

  • Speaker: J Mason Weeda
  • Product ID: 703164
  • Duration: 75 Min
This webinar on FDA Pharmacy Compounding will detail the current thinking, the efforts made and steps taken by FDA and legislatures since the “meningitis outbreak” in 2012.
CD/Recorded
$229
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Recorded/CD
Process Capability Indices in Medical Device Manufacturing

Process Capability Indices in Medical Device Manufacturing

  • Speaker: Daniel O Leary
  • Product ID: 703141
  • Duration: 90 Min
This webinar will help device manufacturers to identify valid statistical techniques to control process capability and product characteristics. It will explain process capability indices in detail and their use.
CD/Recorded
$229
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Recorded/CD
Transferring Medical Device Production to a Contract Manufacturer - Decision Making Process and Procedures

Transferring Medical Device Production to a Contract Manufacturer - Decision Making Process and Procedures

  • Speaker: Rob Braido
  • Product ID: 702719
  • Duration: 90 Min
This webinar on outsourcing medical device manufacturing will discuss practical decision making steps you can follow to analyze whether to transfer or invest in keeping production in-house. If you decide to transfer production, then this training will detail the options and next steps to transferring it to the right facility or contract manufacturer.
CD/Recorded
$229
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Recorded/CD
Writing your Company's Safety Plan: I2P2 (Illness and Injury Prevention Plans) - What you Need to Know and Do

Writing your Company's Safety Plan: I2P2 (Illness and Injury Prevention Plans) - What you Need to Know and Do

  • Speaker: Don Dressler
  • Product ID: 702464
  • Duration: 60 Min
This webinar will be a basic, nuts and bolts program leading participants through the process of creating a written safety plan for evacuation, fire, hazard communication and Others, that complies with OSHA requirements.
CD/Recorded
$149
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Recorded/CD
Managing the Software Development Life Cycle to Produce Regulatory Documentation (for Medical Devices)

Managing the Software Development Life Cycle to Produce Regulatory Documentation (for Medical Devices)

  • Speaker: Tim Stein
  • Product ID: 703158
  • Duration: 60 Min
This webinar will discuss regulatory requirements for the medical device software development process and how the documentation needed for MDD technical files and for FDA submission can be developed as part of that process.
CD/Recorded
$229
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Recorded/CD
Preparing for a US FDA Food Facility Inspection

Preparing for a US FDA Food Facility Inspection

  • Speaker: Edwin V Rivera
  • Product ID: 703155
  • Duration: 60 Min
This webinar will provide an update on the U.S. FDA's new Food Safety Modernization Act, its inspectional process and discuss how to prepare for an FDA inspection.
CD/Recorded
$299
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Recorded/CD
Clinical Importance of Objectionable Organisms

Clinical Importance of Objectionable Organisms

  • Speaker: Ziva Abraham
  • Product ID: 703072
  • Duration: 60 Min
This webinar on objectionable microorganisms will show how to identify and prevent objectionable microorganisms that are beyond the ones outlined in USP <1111>. Attendees will learn the clinical implications due to presence of objectionable microorganisms.
CD/Recorded
$0
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Recorded/CD
Medical Foods: Practical Tips to Meet FDA Requirements for Claims and Quality

Medical Foods: Practical Tips to Meet FDA Requirements for Claims and Quality

  • Speaker: Mukesh Kumar
  • Product ID: 702805
  • Duration: 60 Min
This medical foods regulatory compliance training will explain the regulatory processes to designate and market a product as medical food. Common issues with FDA compliance will be discussed using case studies and potential solutions will be provided.
CD/Recorded
$229
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