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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
Compliance with Canadian Quality Management System Regulatory Requirements

Compliance with Canadian Quality Management System Regulatory Requirements

  • Speaker: Edward Kimmelman
  • Product ID: 704726
  • Duration: 90 Min
The training program will provide insight into complying with the key QMS requirements for organizations selling medical devices in Canada.
CD/Recorded
$279
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Recorded/CD
Navigating Standard 1.2.7 - The Regulation of Nutrition and Health Claims in Australia/NZ

Navigating Standard 1.2.7 - The Regulation of Nutrition and Health Claims in Australia/NZ

  • Speaker: Janine Curll
  • Product ID: 704692
  • Duration: 90 Min
This training program will discuss what is a NCC (Nutrition Content Claims), a GLHC (General Level Health Claims), a HLHC (High Level Health Claims), and the conditions for making these claims. Attendees will understand the conditions on the types of foods that can carry nutrition content and health claims and the process to self–substantiate a food health relationship and requirements for FSANZ notification.
CD/Recorded
$199
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Recorded/CD
FDA's Medical Device Software Regulation

FDA's Medical Device Software Regulation

  • Speaker: Casper Uldriks
  • Product ID: 704749
  • Duration: 90 Min
This training program will focus on FDA software guidance. It will elaborate on applying current provisions that NIST (National Institute of Science and Technology) has put forth in recent reports that FDA will integrate into its regulatory oversight as well.
CD/Recorded
$199
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Recorded/CD
Social Networks and Pharmacovigilance: What Will Change?

Social Networks and Pharmacovigilance: What Will Change?

  • Speaker: Marco Anelli
  • Product ID: 704690
  • Duration: 90 Min
This training program will examine the different types of social networks (Facebook, Twitter, etc.) and help identify similarities, differences, and challenges for pharmacovigilance (PV) professionals. It will also analyze social networks and the new approach to benefit/risk ratio.
CD/Recorded
$0
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Recorded/CD
Sterilizing Grade and Prefilter

Sterilizing Grade and Prefilter

  • Speaker: Mark Trotter
  • Product ID: 704703
  • Duration: 90 Min
This training program will review the latest industry filtration technologies and standards with an overview of regulatory requirements. It will also discuss why and how to determine which filter, the media, and pore ratings that are appropriate for various filtration applications. The program is designed for experienced as well as those new to biopharmaceutical processes. The need-to-know current requirements for specifying sterilizing grade and prefilters in biopharm processes will also be discussed.
CD/Recorded
$0
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Recorded/CD
Using an IQ / OQ / PQ Approach to Validating Medical Device Software

Using an IQ / OQ / PQ Approach to Validating Medical Device Software

  • Speaker: Mercedes Massana
  • Product ID: 702117
  • Duration: 60 Min
This medical device software validation training will show how you can validate software using IQ / OQ / PQ methodologies, typically employed for medical device process validation.
CD/Recorded
$229
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Recorded/CD
How to Write Error Free and FDA Compliant Procedures

How to Write Error Free and FDA Compliant Procedures

  • Speaker: Ginette M Collazo
  • Product ID: 704122
  • Duration: 90 Min
This training program will focus on the importance of procedures. Attendees will learn why people avoid procedures and understand common human errors and deviations related to the use of procedures.
CD/Recorded
$249
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Recorded/CD
Effective CDISC Clinical Data Acceptance Testing and Compliance

Effective CDISC Clinical Data Acceptance Testing and Compliance

  • Speaker: Sunil Gupta
  • Product ID: 704687
  • Duration: 75 Min
This CDISC training program will enumerate clinical data issues, effective methods and SAS macros to identify data issues, and communicating and monitoring improvements in clinical data issues.
CD/Recorded
$0
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Recorded/CD
Process Validation Guidance Requirements, FDA, EU Annex 15; Qualification and Validation

Process Validation Guidance Requirements, FDA, EU Annex 15; Qualification and Validation

  • Speaker: Joy McElroy
  • Product ID: 704737
  • Duration: 4 hrs
This training program will illustrate how these two different concepts are integrated (Phase 1, 2, and 3 vs. Stages 1, 2, and 3) and where do they merge. Attendees will learn if they exist independently of each other or do they complement each other to enhance, build and provide a product.
CD/Recorded
$0
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Recorded/CD
5 Steps to Creating a Rock-Solid Recall Plan

5 Steps to Creating a Rock-Solid Recall Plan

  • Speaker: Valerie Scheidt
  • Product ID: 704720
  • Duration: 60 Min
This training session is designed for food safety practitioners who are preparing for implementation of the Preventive Controls rule, and require assistance in effectively developing a recall plan. Those who have an existing product recall and crisis management program understand that identification of the issue is only the first step in controlling the problem. Operations which have formally relied upon the standards as set forth by certification bodies may wish to reconsider their approach based upon the finalization of the PC Rule.
CD/Recorded
$0
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Recorded/CD
Grant Writing - All You Need to Know About Criteria, Parameters, Obligations, Application Structure and Grant Reporting

Grant Writing - All You Need to Know About Criteria, Parameters, Obligations, Application Structure and Grant Reporting

  • Speaker: Vidia Ramdeen
  • Product ID: 704550
  • Duration: 60 Min
This training program will help participants identify grant opportunities and get started with the grant writing process. They will gain insight into public/private grants, the grant application process and grant reporting.
CD/Recorded
$0
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Recorded/CD
Performing an Effective Risk Assessment of Potential Breaches

Performing an Effective Risk Assessment of Potential Breaches

  • Speaker: Frank Ruelas
  • Product ID: 704682
  • Duration: 60 Min
The Health Insurance Portability and Accountability Act (HIPAA) rules and regulations clearly state that an impermissible use or disclosure is presumed to be a breach. Therefore, any such incident triggers the required notifications. However, if an organization performs a risk assessment and shows why the incident is not a breach, the required notifications would no longer apply. This training program will focus on how to perform an effective risk assessment that can not only reduce the administrative burden of dealing with presumed breaches, but also help an organization meet other criteria such as those that exist in the Office for Civil Rights HIPAA audit protocol.
CD/Recorded
$0
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Recorded/CD
Pharmaceutical Company Specific Records and Information Management Programs

Pharmaceutical Company Specific Records and Information Management Programs

  • Speaker: Charlie Sodano
  • Product ID: 704667
  • Duration: 60 Min
This training program will focus on creating a workable and effective records and information policy. It will also discuss establishing records and information management responsibilities, determining the locations of all information resources, planning long term archiving, and content and records management software considerations and options.
CD/Recorded
$0
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Recorded/CD
Global Considerations for Supplements and Nutritional Products

Global Considerations for Supplements and Nutritional Products

  • Speaker: James Russell
  • Product ID: 704666
  • Duration: 90 Min
This training program will discuss global considerations for supplements and nutritional products as well as the country/region specific considerations for them. It will also elaborate healthcare authorities’ outlook, global expansion challenges, product classification, and marketing challenges in the industry.
CD/Recorded
$0
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Recorded/CD
Renovating Existing Manufacturing Space to Accommodate Aseptic Fill/Finish

Renovating Existing Manufacturing Space to Accommodate Aseptic Fill/Finish

  • Speaker: Erich Bozenhardt
  • Product ID: 704665
  • Duration: 60 Min
This training program will give you the foundational tools necessary to identify changes that need to be made while renovating existing manufacturing space, formulate a concise implementation plan that includes compliance protocols, and allows for continuous improvement.
CD/Recorded
$0
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Recorded/CD
FDA Compliance and Laboratory Computer System Validation

FDA Compliance and Laboratory Computer System Validation

  • Speaker: Carolyn Troiano
  • Product ID: 704660
  • Duration: 60 Min
Upon completion of this training program, attendees will have an understanding of laboratory system computer validation planning, execution and management concepts, based on the System Development Life Cycle (SDLC) framework. They will have received the guidance on industry best practices necessary to develop a compliant and cost-effective validation program. They will understand the steps for validating laboratory systems, along with the key documentation associated with maintaining the systems in a validated state, while minimizing costs. Attendees will gain a good grasp of how to leverage these practices across all systems by creating a standardized program.
CD/Recorded
$0
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Recorded/CD
Good Laboratory Practices for Food Manufacturing

Good Laboratory Practices for Food Manufacturing

  • Speaker: Melinda Allen
  • Product ID: 702539
  • Duration: 90 Min
This 90-minute webinar will show how you can apply FDA's Good Laboratory Practices in a food quality laboratory setting. It will review differences, highlight specific needs of a food lab and provide guidelines for implementation.
CD/Recorded
$229
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Recorded/CD
Don't Fear the Fork: 7 Strategies for Effective Allergen Control

Don't Fear the Fork: 7 Strategies for Effective Allergen Control

  • Speaker: Valerie Scheidt
  • Product ID: 704637
  • Duration: 60 Min
This training program is designed for food safety practitioners who are preparing for implementation of the Preventive Controls Rule, and require assistance in effectively managing allergens. Those who have an existing allergen control program realize that though a plan is in place, compliance and ongoing monitoring is essential for success. Operations which have formally relied upon the standards as set forth by certification bodies may wish to reconsider their approach based upon the finalization of the PC Rule.
CD/Recorded
$0
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Recorded/CD
Preventing Recalls and Product Liability Lawsuits - Current Trends and Causes

Preventing Recalls and Product Liability Lawsuits - Current Trends and Causes

  • Speaker: Randall Goodden
  • Product ID: 703080
  • Duration: 60 Min
This webinar will highlight the current statistics and trends regarding product recalls, product liability lawsuits, and the causes of these economic disasters for manufacturing corporations. It will also identify all the areas of manufacturing management that are typically not being handled properly and contribute to such failures, from product development thru marketing, product testing, supplier selection and control, document management, contracts and agreements, manufacturing quality, and incident investigation.
CD/Recorded
$229
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Recorded/CD
Combination Products - The FDA's New Codifications of the cGMP Requirements Applicable to Combination Products

Combination Products - The FDA's New Codifications of the cGMP Requirements Applicable to Combination Products

  • Speaker: Angela Dunston
  • Product ID: 704623
  • Duration: 120 Min
This training program will analyze the general considerations for cGMP compliance and review the cGMP requirements in 21 CFR 4.4(b). The program will also discuss applications of cGMP requirements for specific types of combination products.
CD/Recorded
$0
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