WEBINARS

 

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

How to Prepare a Standard Operating Procedure (SOP)?

webinar-speaker   Dr. Afsaneh Motamed Khorasani

webinar-time   60 Min

Product Id: 705131

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.

Recording Available

* Per Attendee $299

 

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

webinar-speaker   John Fetzer

webinar-time   60 Min

Product Id: 705292

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.

Recording Available

* Per Attendee $249

 

Automating Assays for Clinical Diagnostics

webinar-speaker   Todd Graham

webinar-time   60 Min

Product Id: 703268

This webinar on automating laboratory assays will teach you how to translate an assay that is performed manually to one that is fully automated, with high quality and with proper validation and quality assurance for regulatory purposes.

Recording Available

 

Where FDA Is Heading in Regulating Laboratory-Developed Tests

webinar-speaker   Dennis Weissman

webinar-time   60 Min

Product Id: 705335

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.

Recording Available

* Per Attendee $249

 

SOP's for Bioanalytical Methods Validation

webinar-speaker   Todd Graham

webinar-time   60 Min

Product Id: 704916

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.

Recording Available

 

Sample Quality Control for Molecular Diagnostics

webinar-speaker   Todd Graham

webinar-time   60 Min

Product Id: 705222

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 laboratory challenges in clinical laboratory.

Recording Available

* Per Attendee $299

 

Assay Validation for Clinical Diagnostics

webinar-speaker   Todd Graham

webinar-time   60 Min

Product Id: 702872

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.

Recording Available

* Per Attendee $249

 

Gaining and Re-establishing Control of Your Cleanroom

webinar-speaker   Joy McElroy

webinar-time   60 Min

Product Id: 705317

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.

Recording Available

* Per Attendee $249

 

How to undergo an FDA Inspection Successfully

webinar-speaker   Marie Morin

webinar-time   90 Min

Product Id: 705170

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.

Recording Available

* Per Attendee $249

 

The Latest in CLIA Compliance for Clinical Labs

webinar-speaker   Dennis Weissman

webinar-time   90 Min

Product Id: 705374

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.

Recording Available

 

FDA Inspections: What Regulations Expect

webinar-speaker   Joy McElroy

webinar-time   90 Min

Product Id: 705346

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.

Recording Available

* Per Attendee $249

 

Vendor Qualification for Quality Services

webinar-speaker   Todd Graham

webinar-time   60 Min

Product Id: 705285

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.

Recording Available

 

Quality Control for Microbiological Media and Reagents

webinar-speaker   Todd Graham

webinar-time   60 Min

Product Id: 705060

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.

Recording Available

* Per Attendee $249

 

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

webinar-speaker   Charity Ogunsanya

webinar-time   90 Min

Product Id: 705018

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.

Recording Available

 

FDA Compliance and Laboratory Computer System Validation

webinar-speaker   Carolyn Troiano

webinar-time   60 Min

Product Id: 704660

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.

Recording Available

 

Worksheets that Capture SOP Details and Are Compliant

webinar-speaker   Edward O Connor

webinar-time   60 Min

Product Id: 704532

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.

Recording Available

 

Process Robustness: The New FDA Paradigm

webinar-speaker   Angela Dunston

webinar-time   90 Min

Product Id: 703990

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.

Recording Available

* Per Attendee $229

 

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

webinar-speaker   Barry Craig

webinar-time   60 Min

Product Id: 701305

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.

Recording Available

* Per Attendee $229

 

LDT including CDx; CLIA versus FDA's Authority

webinar-speaker   Abdel Halim

webinar-time   60 Min

Product Id: 703399

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.

Recording Available

* Per Attendee $229

 

The CLIA Laboratory Inspection: Failure is not an Option

webinar-speaker   Barry Craig

webinar-time   60 Min

Product Id: 701639

This Laboratory compliance training will discuss the salient features of inspection as per Clinical Laboratory Improvement Amendments (CLIA) guidelines.

Recording Available

* Per Attendee $299

 

 

 

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