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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
FDA Regulation of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps)

FDA Regulation of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps)

  • Speaker: Mukesh Kumar
  • Product ID: 703652
  • Duration: 90 Min
This webinar will highlight rules governing HCT/Ps using case studies. Practical suggestions for compliance with FDA requirements and tips to negotiate with the agency regarding disputes with interpretation of the law will form the core of this training session.
CD/Recorded
$229
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Recorded/CD
How to Most Effectively Prepare for and Manage FDA Inspection: Best Practices

How to Most Effectively Prepare for and Manage FDA Inspection: Best Practices

  • Speaker: David Lim
  • Product ID: 703245
  • Duration: 60 Min
This training program will discuss why it is important for you to be better aware of and to become better acquainted with FDA inspection best practices. In particular, the webinar will detail a list of Dos and Don’ts before, during and after the inspection.
CD/Recorded
$229
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Recorded/CD
Good Documentation Practices (GDP)

Good Documentation Practices (GDP)

  • Speaker: Alla Teresh
  • Product ID: 703874
  • Duration: 60 Min
This training program will detail best practices for documentation, list types of documents, and highlight key documentation requirements. Documentation is essential where FDA and other health authority regulations impose a special recordkeeping burden. In these industries, documentation serves both the scientific and compliance needs, and Good Documentation Practices (GDPs) are a set of activities that enable you to record your data and hand-written entries in a legible, traceable and reproducible manner.
CD/Recorded
$229
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Recorded/CD
Corrective and Preventive Action Utilizing the Principles of Lean Documents and Lean Configuration

Corrective and Preventive Action Utilizing the Principles of Lean Documents and Lean Configuration

  • Speaker: Jose Mora
  • Product ID: 703879
  • Duration: 90 Min
This training program on lean documents will present a fresh departure from general practices, while building upon proven principles. The theory of lean documents is the product of applying lean principles to the creation, design, process, and management of controlled documents typically found in regulated industries. Just as lean principles challenge traditional process concepts and push systems, many traditional document practices are artifacts of a flawed approach. This webinar will highlight how lean configuration comes from the same principles, and utilizes the unique power of software solutions to take over functions that had previously burdened controlled paper documents.
CD/Recorded
$229
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Recorded/CD
Preparing for and Managing FDA Inspections

Preparing for and Managing FDA Inspections

  • Speaker: Jonathan M Lewis
  • Product ID: 703512
  • Duration: 90 Min
This webinar will teach attendees how to prepare for, manage, and follow up on FDA inspections. It will discuss common pitfalls to avoid during an inspection.
CD/Recorded
$279
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Recorded/CD
Nutraceuticals/Dietary Supplements: FDA Regulatory Submission and Manufacturing Quality Requirements

Nutraceuticals/Dietary Supplements: FDA Regulatory Submission and Manufacturing Quality Requirements

  • Speaker: Gretchen Bowker
  • Product ID: 702741
  • Duration: 60 Min
This dietary supplements quality compliance training will review the FDA regulatory requirements for manufacturing and commercialization of dietary supplements. You will gain a complete understanding of FDA requirements for manufacturing of nutraceuticals, food drugs, and dietary supplements.
CD/Recorded
$229
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Recorded/CD
FDA vs. EU Inspections - Getting Prepared and What are Differences

FDA vs. EU Inspections - Getting Prepared and What are Differences

  • Speaker: Marie Dorat
  • Product ID: 703516
  • Duration: 75 Min
This webinar will help attendees understand the FDA and EU inspection process and how to prepare for both of them. Attendees will learn the best practices to respond to Form 483 citations, Warning Letters and EU inspection findings.
CD/Recorded
$229
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Recorded/CD
Clinical Trial Liability Lawsuits

Clinical Trial Liability Lawsuits

  • Speaker: Jonathan Mcdermed
  • Product ID: 703645
  • Duration: 60 Min
This hour-long session will provide insights on liabilities arising due to non-compliance and oversight in clinical trials. The clinical affairs expert will also discuss identifying the types of litigation and how best to eliminate the source of risk with real world examples. Participants will learn to appreciate the importance of formal training in conducting proficient clinical trials.
CD/Recorded
$229
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Recorded/CD
ICH Q10 - Moving From GMPs To A Pharmaceutical Quality System

ICH Q10 - Moving From GMPs To A Pharmaceutical Quality System

  • Speaker: John G Lanese
  • Product ID: 701441
  • Duration: 90 Min
This ICH Q10 training /webinar will discuss the evolution and interpretation of the pharmaceutical GMPs as a quality control regulation to the Quality Assurance emphasis of the Pharmaceutical Quality System as defined in ICH Q10.
CD/Recorded
$179
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Recorded/CD
Validation of Analytical Methods According to the New FDA Guidance

Validation of Analytical Methods According to the New FDA Guidance

  • Speaker: Dr. Ludwig Huber
  • Product ID: 703623
  • Duration: 75 Min
This webinar will elaborate the scope and content of the recent FDA guidance on validation of analytical methods. The webinar will also illustrate the lifecycle management of analytical procedures and train attendees on documentation requirements and verification of submitted methods.
CD/Recorded
$179
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Recorded/CD
Food Allergen Programs: Management of Allergen Cross-Contamination and Validation of Cleaning Procedures to Ensure Effective Removal

Food Allergen Programs: Management of Allergen Cross-Contamination and Validation of Cleaning Procedures to Ensure Effective Removal

  • Speaker: Rotimi Toki
  • Product ID: 702677
  • Duration: 90 Min
This webinar will provide guidance on how to develop and implement an effective cleaning validation plan, customized for specific scenarios, to ensure that the allergen is removed from the food processing line or equipment.
CD/Recorded
$229
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Recorded/CD
Writing and Implementing Statistical Analysis Plans (SAPs) - Domestic and International Guidance under ICH E9

Writing and Implementing Statistical Analysis Plans (SAPs) - Domestic and International Guidance under ICH E9

  • Speaker: Rita Hanover
  • Product ID: 702783
  • Duration: 90 Min
This training on clinical trial Statistical Analysis Plans (SAP) will review writing, timing and specific content of the SAP in the context of FDA guidance based on ICH E9 with references to ICH E3 and E6. We will work through a sample template and discuss how to approach each section for maximum clarity and ease of interpretation at the end of a study.
CD/Recorded
$50
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Recorded/CD
Best Practices for Cleaning and Material Handling in Sterile Compounding Facilities

Best Practices for Cleaning and Material Handling in Sterile Compounding Facilities

  • Speaker: Kate Douglass
  • Product ID: 703807
  • Duration: 60 Min
This webinar will clarify the cleaning and material handling requirements outlined in USP 797 and present additional best practice guidelines. It will discuss principles related to the selection, preparation and use of cleaning, disinfection and deactivation agents. The correct sequencing of critical activities related to daily and monthly cleaning of both primary and secondary engineering controls will be presented as well.
CD/Recorded
$229
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Recorded/CD
Deviations: What are they? Do you need to report?

Deviations: What are they? Do you need to report?

  • Speaker: Sarah Fowler Dixon
  • Product ID: 702394
  • Duration: 60 Min
This webinar will help you clearly understand, classify and determine what deviations to report in clinical studies. It will also explain, in detail, the terminology applied to deviations.
CD/Recorded
$229
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Recorded/CD
FDA’s Proposed Preventative Control Regulation for Human Food under FSMA- 21CFR Part 117 and What You Should Know Now to Prepare for When it Becomes Effective in 2015

FDA’s Proposed Preventative Control Regulation for Human Food under FSMA- 21CFR Part 117 and What You Should Know Now to Prepare for When it Becomes Effective in 2015

  • Speaker: Brian Hendrickson
  • Product ID: 703706
  • Duration: 90 Min
This webinar will summarize the regulatory requirements for FDA’s proposed new regulation – “Current Good Manufacturing Practice and Hazard Analysis and Risk Based Preventative Controls for Human Food” - 21CFR Part 117. The GMP component of this regulation (Subpart B) is intended to replace the current outdated GMP regulation (21CFR Part 110) when it becomes effective, as expected, in 2015.
CD/Recorded
$229
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Recorded/CD
Implementing FDA's 21 CFR 111 for Dietary Supplements

Implementing FDA's 21 CFR 111 for Dietary Supplements

  • Speaker: Dr. Ludwig Huber
  • Product ID: 703737
  • Duration: 75 Min
Although FDA's Dietary Supplement Current Good Manufacturing Practice (CGMP) Final Rule 21 CFR Part 111 has been enforced since 2010, manufacturers, distributors and importers are still not completely aware of its impact. This webinar will highlight best practices for implementing 21 CFR 111 for dietary supplements.
CD/Recorded
$229
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Recorded/CD
Understanding ISO 13485 and its Relation to FDA's Quality Systems Regulation

Understanding ISO 13485 and its Relation to FDA's Quality Systems Regulation

  • Speaker: Jessica Czamanski
  • Product ID: 703630
  • Duration: 90 Min
This webinar will highlight the distinctions between ISO 13485 and FDA’s QSR. It will further introduce attendees to key clauses and requirements pertaining to the two regulations and also detail internal audit requirements.
CD/Recorded
$229
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Recorded/CD
Elements of an Effective Change Control System

Elements of an Effective Change Control System

  • Speaker: Michael Ferrante
  • Product ID: 703345
  • Duration: 60 Min
This webinar will focus on the regulatory and design requirements for an effective change control system in the pharmaceutical industry. Attendees will learn the role and importance of change control system in implementing an effective quality system.
CD/Recorded
$229
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Recorded/CD
Technology Transfer of a Pharmaceutical Manufacturing Process

Technology Transfer of a Pharmaceutical Manufacturing Process

  • Speaker: Mark Truei
  • Product ID: 703682
  • Duration: 90 Min
This expert instruction on technology transfer of a pharmaceutical manufacturing process will highlight with real world examples hidden traps in technology transfer not covered under its requirements. This webinar will help attendees ensure the success of tech transfer under any circumstance regardless of fields, countries, cultures, and applications.
CD/Recorded
$149
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Recorded/CD
Maintaining a Validated State – PV, PM and Statistics Associated with Current Regulation

Maintaining a Validated State – PV, PM and Statistics Associated with Current Regulation

  • Speaker: Jerry Dalfors
  • Product ID: 703637
  • Duration: 80 Min
This course will instruct attendees on establishing an approach to process control within each unit of operation to generate overall process control needed for validation. The webinar instructor, an FDA expert, will enumerate the importance of variation in enhancing a validated means of operation and the parameters that can cause variability. The Randomized Block statistical model will also be analyzed for effective validation.
CD/Recorded
$229
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