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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
How to Survive FDA's New Inspection and Enforcement Practices

How to Survive FDA's New Inspection and Enforcement Practices

  • Speaker: Dr. Ludwig Huber
  • Product ID: 704328
  • Duration: 75 Min
This training program will enumerate the inspection process for API, drug and device manufacturers and summarize recent changes. It will guide attendees on preparing staff for the new FDA inspections and discuss the role of exit meeting to avoid enforcement.
CD/Recorded
$229
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Recorded/CD
FDA's Expectations from Supplier Management for GMP: Quality Agreements and More

FDA's Expectations from Supplier Management for GMP: Quality Agreements and More

  • Speaker: Mukesh Kumar
  • Product ID: 703483
  • Duration: 90 Min
This webinar will review FDA’s regulations related to suppliers in manufacture of drugs, biologics and medical devices. It will discuss the current regulations, guidance documents and best practices for supplier management and enforceable quality agreement using case studies for a variety of scenarios. Common FDA audit findings will be discussed.
CD/Recorded
$229
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Recorded/CD
Vendor Management: What Accounts Payable and Purchasing Need to Know and Do

Vendor Management: What Accounts Payable and Purchasing Need to Know and Do

  • Speaker: Jon Casher
  • Product ID: 704300
  • Duration: 60 Min
This purchasing and accounts payable training will focus on why you need a comprehensive program to address critical issues associated with vendor management. It will identify critical vendor management issues, provide a comprehensive step by step approach to vendor management and identify best and appropriate practices for managing all aspects of your vendor relationships.
CD/Recorded
$149
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Recorded/CD
Kaizen Approach to ISO 9001:2015

Kaizen Approach to ISO 9001:2015

  • Speaker: Mike Micklewright
  • Product ID: 704298
  • Duration: 90 Min
This training program will discuss the new requirements of ISO 9001:2015. It will also detail risk management and how it relates to Kaizen/Lean efforts. Attendees will learn how to integrate all Kaizen/Lean practices with the quality management system as well.
CD/Recorded
$229
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Recorded/CD
EU Food Contact Regulatory

EU Food Contact Regulatory

  • Speaker: Juergen Towara
  • Product ID: 704280
  • Duration: 90 Min
This training program will focus on the main regulations and standards behind EU food contact regulatory including EU Framework Regulation for Food Contact, EU Plastics Regulation 10/2011, and EU GMP Requirements.
CD/Recorded
$229
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Recorded/CD
Generic Drug Product Development (ANDA) and Paragraph IV Filing Strategy (Exclusive to the US Market)

Generic Drug Product Development (ANDA) and Paragraph IV Filing Strategy (Exclusive to the US Market)

  • Speaker: Aditya Das
  • Product ID: 702909
  • Duration: 60 Min
This webinar will help you understand the rationale for Generic Drug Product Development via an ANDA Filing and the potential added value of a Paragraph IV Application, exclusive to the US market.
CD/Recorded
$50
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Recorded/CD
Validation of Purified Water Systems

Validation of Purified Water Systems

  • Speaker: Igor Gorsky
  • Product ID: 704272
  • Duration: 150 Min
This training program will dispel mistaken paradigms regarding the risk based approach to water system lifecycle. It will detail how to eliminate variability – the cause of most deviations. Attendees will learn how to capitalize on the advantages of online analytical instrumentation (chemical and microbiological rapid methods).
CD/Recorded
$50
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Recorded/CD
FDA and MHRA Pharmacovigilance Inspection Readiness and Management

FDA and MHRA Pharmacovigilance Inspection Readiness and Management

  • Speaker: Kathleen Humel
  • Product ID: 704181
  • Duration: 60 Min
This discussion is geared for the pharmaceutical industry. It will provide pharmacovigilance (product safety) departments with solid ideas to help them prepare for and manage a health authority inspection. Medical information, research and development and quality and compliance groups in the pharmaceutical industry would benefit from tips discussed in this session as well.
CD/Recorded
$50
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Recorded/CD
Product Safety Compliance

Product Safety Compliance

  • Speaker: Richard Maksimoski
  • Product ID: 704215
  • Duration: 60 Min
The attendee will leave this session with more confidence, vision, and productivity. The confidence is knowing that you have more tools to keep your product in compliance with regulatory and company standards. The ability to establish the necessary processes will allow you to have confidence that your company will be safe.
CD/Recorded
$149
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Recorded/CD
Understanding and Implementing the EU Vigilance System

Understanding and Implementing the EU Vigilance System

  • Speaker: Daniel O Leary
  • Product ID: 704205
  • Duration: 90 Min
This training program will furnish attendees with an overview of the EU vigilance system and the understanding and tools necessary for effective QMS implementation. It will also provide an implementation checklist for the vigilance system.
CD/Recorded
$229
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Recorded/CD
Auditing QC and Contract Laboratories for GMP Compliance

Auditing QC and Contract Laboratories for GMP Compliance

  • Speaker: Dr. Ludwig Huber
  • Product ID: 703808
  • Duration: 75 Min
This course will explore why auditing laboratories is the ideal tool to verify compliance of laboratory practices. It will guide attendees in preparing for FDA inspections, while detailing documentation requirements for the FDA and ISO.
CD/Recorded
$229
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Recorded/CD
Mathematics of Terminal Sterilization - Probability of Survival Approach vs Overkill Approach

Mathematics of Terminal Sterilization - Probability of Survival Approach vs Overkill Approach

  • Speaker: Jerry Dalfors
  • Product ID: 703633
  • Duration: 80 Min
This course will detail various sterilization methods and various approaches for the validation of a sterilization process.
CD/Recorded
$229
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Recorded/CD
Maintaining Food Safety and Customer Satisfaction through effective Specification Development and Implementation

Maintaining Food Safety and Customer Satisfaction through effective Specification Development and Implementation

  • Speaker: Angeline Benjamin
  • Product ID: 701561
  • Duration: 60 Min
Product Specifications are customer’s greatest tool for ensuring products received meet the quality and safety standards expected. This webinar will cover the strategies followed by examples on how to develop an effective product specification that would help managing food safety and customer satisfaction.
CD/Recorded
$229
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Recorded/CD
Setting Up an Environmental Monitoring Program for Non-Sterile Manufacturing

Setting Up an Environmental Monitoring Program for Non-Sterile Manufacturing

  • Speaker: Steve Yeger
  • Product ID: 703444
  • Duration: 60 Min
This webinar will focus on the process of establishing an environmental monitoring program for non-sterile manufacturing facility and the need to design a system and routine that will satisfy the expectations of the global regulatory agencies. It will also address the different pharmacopeial regulations and current regulatory trends.
CD/Recorded
$229
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Recorded/CD
Pest Control Program for Food Processing Facilities

Pest Control Program for Food Processing Facilities

  • Speaker: Betty Zakeri
  • Product ID: 704041
  • Duration: 60 Min
This training program will illustrate the role and responsibilities of an efficient well-rounded pest control manager. It will highlight various types of pest control programs and discuss mandatory records to be maintained for compliance.
CD/Recorded
$229
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Recorded/CD
Documentation Requirements for Master and Working Cell Banks

Documentation Requirements for Master and Working Cell Banks

  • Speaker: Debra Barngrover
  • Product ID: 704030
  • Duration: 60 Min
This training program will prepare attendees for new regulatory requirements that will arise and apply to your cell line, even if it was made before the requirements were in place. One of the first steps in a recombinant project is the development of the cell line to produce the protein of interest, generally years before the product will be filed for licensure. How do you peer into the future to make sure that when the day comes to file for approval that you have collected and saved all the necessary information on that cell line and your master and working cell banks? Don’t make the mistake of assuming that you can find all that information years from now – create a plan to ensure everything is documented and saved.
CD/Recorded
$229
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Recorded/CD
Regulation of Polymers and Paper Used in Food Packaging

Regulation of Polymers and Paper Used in Food Packaging

  • Speaker: Jeffrey Scott Eberhard
  • Product ID: 703546
  • Duration: 60 Min
This webinar on the regulation of common materials used in food packaging will feature relevant elements of 21 CFR as well as USFDA guidance documents pertaining to the subject matter. It will help attendees understand the process and plan for packaging regulation as an integral part of product development efforts.
CD/Recorded
$229
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Recorded/CD
The Microbial Factor of Non-Sterile Cleaning Validation

The Microbial Factor of Non-Sterile Cleaning Validation

  • Speaker: Steve Yeger
  • Product ID: 703360
  • Duration: 60 Min
This webinar will focus on the microbiological element of non-sterile manufacturing cleaning validation and the need to design a robust cleaning routine. It will address the different pharmacopoeia regulations and current regulatory trends. It will also cover the theory in setting the baseline profile and limits along with determination of routine testing.
CD/Recorded
$229
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Recorded/CD
Navigating the New FDA Draft Guidance on ISO 10993: Biological Evaluation of Medical Devices

Navigating the New FDA Draft Guidance on ISO 10993: Biological Evaluation of Medical Devices

  • Speaker: Cheryl Wagoner
  • Product ID: 703585
  • Duration: 60 Min
The webinar will focus on the amendments made to the Blue Book Memorandum #G95-1 Use of International Standards ISO-10993, “Biological Evaluation of Medical Devices Part 1: Evaluation and Testing.” It will help attendees stay updated with the current trends set out by the amendments to the guideline and help them draft guidance documents that will impact their business.
CD/Recorded
$229
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Recorded/CD
Improving Sanitation Standard Operating Procedures In the Food Industry

Improving Sanitation Standard Operating Procedures In the Food Industry

  • Speaker: Angeline Benjamin
  • Product ID: 701642
  • Duration: 60 Min
In this Food Safety training learn how to create and implement a sanitation SOP to avoid failure of the HACCP system.
CD/Recorded
$229
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