ComplianceOnline

Clinical Laboratory Regulatory Compliance Training - Live Webinars, Recordings & CDs

Assay Validation for Clinical Diagnostics
19
/ Dec
Wednesday-2018

Assay Validation for Clinical Diagnostics

  • Speaker: Todd Graham
  • Product ID: 702872
  • Duration: 60 Min
This training on assay validation will teach you how to validate an assay for clinical diagnostics and transition the assay into the clinical laboratory for diagnostic use.
* Per Attendee
$199
Sample Quality Control for Molecular Diagnostics
20
/ Feb
Wednesday-2019

Sample Quality Control for Molecular Diagnostics

  • Speaker: Todd Graham
  • Product ID: 705222
  • Duration: 60 Min
In this webinar attendees will learn the key issues and sample requirements (collection methods, sample inhibition and sample volume) for molecular diagnostics and the tools (PCR, DNA fluorescent assays & NGS assays) you need to deal with your laboratories challenges in clinical laboratory.
* Per Attendee
$199
Recorded/CD
Gaining and Re-establishing Control of Your Cleanroom

Gaining and Re-establishing Control of Your Cleanroom

  • Speaker: Joy McElroy
  • Product ID: 705317
  • Duration: 60 Min
This webinar will focus on the critical steps in starting up a new cleanroom operation and releasing it for manufacturing. It includes a case study-based approach to dealing with excursion events and establishing control of the cleanroom after a worst case event.
CD/Recorded
$249
Recorded/CD
Where FDA Is Heading in Regulating Laboratory-Developed Tests

Where FDA Is Heading in Regulating Laboratory-Developed Tests

  • Speaker: Dennis Weissman
  • Product ID: 705335
  • Duration: 60 Min
The webinar will cover the federal regulatory approach to regulating laboratory-developed tests including the role of CLIA, the rationale for and opposition to direct FDA oversight, the goal of possible federal legislation and the prospects for future action by the FDA and/or Congress.
CD/Recorded
$249
Recorded/CD
How to undergo an FDA Inspection Successfully

How to undergo an FDA Inspection Successfully

  • Speaker: Marie Morin
  • Product ID: 705170
  • Duration: 90 Min
This webinar will discuss best practices for preparing for an international announced inspection as well as how to be always prepared for those in the US who may be inspected at any time. It also discusses the various roles of the persons who will be assisting during the inspection and suggests how to organize support personnel to aid in keeping the inspection going smoothly and identify and address issues before FDA sees them.
CD/Recorded
$249
Recorded/CD
The Use of Monitoring and Statistics to Prevent Non-Compliance in the Laboratory

The Use of Monitoring and Statistics to Prevent Non-Compliance in the Laboratory

  • Speaker: John Fetzer
  • Product ID: 705292
  • Duration: 60 Min
This webinar will cover the basic statistics of compliance and non-compliance and how to use a statistical approach to monitor the operation in the laboratory.
CD/Recorded
$249
Recorded/CD
The Latest in CLIA Compliance for Clinical Labs

The Latest in CLIA Compliance for Clinical Labs

  • Speaker: Dennis Weissman
  • Product ID: 705374
  • Duration: 90 Min
This webinar will cover in detail the regulatory requirements of Clinical Laboratory Improvement Amendments (CLIA). It will also discuss major lab quality standards such as facility administration, general laboratory systems, personnel qualifications & responsibilities, proficiency testing and more.
Recorded/CD
FDA Inspections: What Regulations Expect

FDA Inspections: What Regulations Expect

  • Speaker: Joy McElroy
  • Product ID: 705346
  • Duration: 90 Min
Attend this webinar to increase one’s knowledge of FDA inspections, what inspectors are looking for and expect to see and not to see in manufacturing facilities. It will provide an in-depth understanding of how to prepare for unannounced FDA audits and inspections.
CD/Recorded
$249
Recorded/CD
Vendor Qualification for Quality Services

Vendor Qualification for Quality Services

  • Speaker: Todd Graham
  • Product ID: 705285
  • Duration: 60 Min
This webinar will teach you how and when to implement complimentary activities to an outsourced quality function and how to integrate this information into a fully-functioning program.
Recorded/CD
How to prepare a winning Standard Operating Procedure (SOP)

How to prepare a winning Standard Operating Procedure (SOP)

  • Speaker: Dr. Afsaneh Motamed Khorasani
  • Product ID: 705131
  • Duration: 60 Min
This webinar will detail a step-by-step procedure on how to write a practical, effective and compliant Standard Operating Procedures (SOPs), review and revise SOPs and maintain compliance over the course of the SOP life-time.
Recorded/CD
Quality Control for Microbiological Media and Reagents

Quality Control for Microbiological Media and Reagents

  • Speaker: Todd Graham
  • Product ID: 705060
  • Duration: 60 Min
This webinar will give you the tools you need to maintain a quality supply of media and reagents in a variety of microbiology laboratories. A thorough understanding of the variety of challenges necessary in maintain quality media and reagents will be brought to the fore. This will allow you to perform microbiology testing with confidence.
CD/Recorded
$249
Recorded/CD
Designing an Effective and Compliant Standard Operating Procedure (SOP) and Standard Test Method (STM)

Designing an Effective and Compliant Standard Operating Procedure (SOP) and Standard Test Method (STM)

  • Speaker: Charity Ogunsanya
  • Product ID: 705018
  • Duration: 90 Min
This webinar training will benefit manufacturers of manufactured products to achieve an effective, robust and compliant SOP and STM which will result in a cost effective and efficient manufacturing and testing of products. A well planned and written SOP or STM will reduce the incidence of out-of-specification (OOS) results, failure, product non-conformances, deviation and invalid assay investigations.
Recorded/CD
SOP's for Bioanalytical Methods Validation

SOP's for Bioanalytical Methods Validation

  • Speaker: Todd Graham
  • Product ID: 704916
  • Duration: 60 Min
This webinar will help you learn how to validate bioanalytical methods. This session will teach you the pitfalls behind bioanalytical methods validation, allowing one to transition between assays with ease.
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.
Recorded/CD
Worksheets that Capture SOP Details and Are Compliant

Worksheets that Capture SOP Details and Are Compliant

  • Speaker: Edward O Connor
  • Product ID: 704532
  • Duration: 60 Min
This training program will focus on understanding the drivers and benefit of using worksheets not only as a prompt for recording details but also in reducing efforts of the analysts and auditors in a GLP/GCP bioanalytical lab.
Recorded/CD
Process Robustness: The New FDA Paradigm

Process Robustness: The New FDA Paradigm

  • Speaker: Angela Dunston
  • Product ID: 703990
  • Duration: 90 Min
In this training program, attendees will learn how process robustness tools and metrics can be utilized to enhance process understanding and control. The new FDA paradigm is shifting to the expectation that organizations certified by other standards such as ISO and EFfCI demonstrate process robustness. It is the obligation of the primary pharmaceutical provider to ensure process robustness throughout the supply chain.
CD/Recorded
$229
Recorded/CD
CLIA (Clinical Laboratory Improvement Amendments) Guidelines on Quality Control and Quality Assessment

CLIA (Clinical Laboratory Improvement Amendments) Guidelines on Quality Control and Quality Assessment

  • Speaker: Barry Craig
  • Product ID: 701305
  • Duration: 60 Min
This Clinical Laboratory Improvement Amendments (CLIA) training will be valuable to CLIA regulated, non-waived laboratories that run automated analyzers or semi-quantitative kit tests. It will highlight differences between quality control and quality assessment and the proper methods to meet CLIA guidelines.
CD/Recorded
$229
Recorded/CD
LDT including CDx; CLIA versus FDA's Authority

LDT including CDx; CLIA versus FDA's Authority

  • Speaker: Abdel Halim
  • Product ID: 703399
  • Duration: 60 Min
This webinar will explain the regulatory path of an in vitro diagnostic (IVD) and Laboratory Developed Test (LDT). It will discuss the CLIA regulations for Laboratory Developed Tests (LDTs), including companion diagnostics (CDx) and how these differ from the FDA’s authority.
CD/Recorded
$229
Recorded/CD
The CLIA Laboratory Inspection: Failure is not an Option

The CLIA Laboratory Inspection: Failure is not an Option

  • Speaker: Barry Craig
  • Product ID: 701639
  • Duration: 60 Min
This Laboratory compliance training will discuss the salient features of inspection as per Clinical Laboratory Improvement Amendments (CLIA) guidelines.
CD/Recorded
$299
Recorded/CD
Decoding CLIA (Clinical Laboratory Improvement Amendments) Regulations: Calibration, Calibration Verification and Method Validation

Decoding CLIA (Clinical Laboratory Improvement Amendments) Regulations: Calibration, Calibration Verification and Method Validation

  • Speaker: Barry Craig
  • Product ID: 701304
  • Duration: 75 Min
The Clinical Laboratory Improvement Amendments (CLIA) training will outline the CLIA standards for frequency, methodology and also give examples of practical application.
CD/Recorded
$229
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