WEBINARS

 

Laboratory Testing and Validation Regulatory Compliance Training - Live Webinars, Recordings & CDs

How to Survive a DEA Inspection Series: For DEA Registered Analytical Labs and Research Facilities

webinar-speaker   Carlos M Aquino

webinar-time   90 Min

Product Id: 704617

The training program will cover DEA record-keeping requirements and effective security that a DEA registrant must comply with when handling controlled substances. It covers elements of what occurs during an unannounced inspection and the auditing methods.

17 / Nov / 2021 - Wednesday

* Per Attendee $229

 

Measurement Uncertainty in Microbiology

webinar-speaker   Michael Brodsky

webinar-time   60 Min

Product Id: 703902

This training program will discuss the concept and application of uncertainty of measurement (MU) as required by ISO/IEC Standard 17025:2005 for laboratory accreditation, from a practical microbiological perspective, using unambiguous language and useful examples.

Recording Available

* Per Attendee $249

 

Best Practices for an Effective Cleaning Validation Program

webinar-speaker   Joy McElroy

webinar-time   60 Min

Product Id: 704329

This training program will be beneficial to personnel directly involved in the development of cleaning procedures, cleaning validation programs and plans. Additionally, those responsible for cleaning validation protocols and execution activities, including validation and laboratory personnel, as well as, beginning or seasoned operational personnel who will eventually participate in such efforts, will find this course particularly useful.

Recording Available

* Per Attendee $299

 

Good Laboratory Practices (GLPs) - Comparing and Contrasting with Good Manufacturing Practices (GMPs)

webinar-speaker   Joy McElroy

webinar-time   120 Min

Product Id: 704086

The objective of this webinar is to compare and contrast between Good Laboratory Practices and Good Manufacturing practices.

Recording Available

* Per Attendee $349

 

Best Practices for Equipment Validation, Tracking, Calibration, and Preventive Maintenance

webinar-speaker   Jeff Kasoff

webinar-time   60 Min

Product Id: 701142

This Quality management training will provide valuable assistance in process development include in Equipment Validation, Tracking, Calibration, and Preventive Maintenance.

Recording Available

* Per Attendee $249

 

Product Stability Testing Program - Designing and Sustaining New and Existing Programs

webinar-speaker   Charity Ogunsanya

webinar-time   90 Min

Product Id: 703000

This life science product stability testing webinar will explain, in detail, the requirements of the FDA’s drug stability guidelines that are stipulated for drug products and how to design a product stability testing plan that can be applied to new or modified products in the pharmaceutical, biotechnology and medical device industries.

Recording Available

* Per Attendee $299

 

Implementation and Management of GMP Data Integrity

webinar-speaker   Danielle DeLucy

webinar-time   90 Min

Product Id: 705029

Attend this webinar to learn the regulatory expectations for data integrity during CGMP inspections. The course will review examples of data integrity pitfalls, part 11 compliance data integrity issues, FDA citations related to data integrity. It will teach you how to improve data integrity in a laboratory environment.

Recording Available

* Per Attendee $299

 

Bioanalytical Methods Validation

webinar-speaker   Edward O Connor

webinar-time   60 Min

Product Id: 701769

This training on bio-analytical methods validation will help you to understand the FDA and EMA guidance for Instrumental, ligand binding and cell-based assays and also review of recent 483s impacting validation.

Recording Available

* Per Attendee $299

 

Validation of HPLC/UPLC Methodologies

webinar-speaker   John Fetzer

webinar-time   60 Min

Product Id: 705291

This training program will cover in detail the key elements of HPLC and UPLC method validation to ensure compliance with FDA GLP and ISO 17025 requirements.

Recording Available

* Per Attendee $249

 

Validation of GC / GC-MS Methodologies

webinar-speaker   John Fetzer

webinar-time   60 Min

Product Id: 705259

This training program will cover in detail the method validation of gas chromatography (GC) and gas chromatography mass spectrometry (GC-MS). It will focus on key elements of validation including injector, column, detection system, data system and much more.

Recording Available

* Per Attendee $249

 

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

 

Laboratory Investigations Relating to Sample Re-Analysis: Covering the Basics Before Being Called Out

webinar-speaker   Edward O Connor

webinar-time   60 Min

Product Id: 701439

This webinar on laboratory investigation will provide guidance on procedures used in investigating unexpected results for non-clinical and clinical trials and will discuss several suggested procedures, avoiding unnecessary re-analysis.

Recording Available

* Per Attendee $299

 

Conducting Effective Investigations of Out of Specification and Atypical Laboratory Results

webinar-speaker   Gregory Martin

webinar-time   120 Min

Product Id: 702360

This training on pharmaceutical laboratory OOS investigations will explain how to recognize and address atypical or out of specification results, using approaches which have been recommended by regulatory authorities, performing appropriate investigations.

Recording Available

* Per Attendee $299

 

QbD Approach to Analytical Method Lifecycle: Design, Development, Validation and Transfer

webinar-speaker   Gregory Martin

webinar-time   90 Min

Product Id: 703644

This training on using the QbD approach to analytical method lifecycle is designed to provide participants with a lifecycle approach to developing and validating analytical methods and comply with compendial requirements. The webinar presenter will use case studies to illustrate each stage in the process.

Recording Available

* Per Attendee $299

 

Data Governance for Computer Systems Regulated by FDA

webinar-speaker   Carolyn Troiano

webinar-time   60 Min

Product Id: 704745

In this webinar attendees will learn about FDA’s regulatory expectations for classifying, assessing the risk, testing, and validating a computer system used in FDA-regulated work. Also attendees will learn in detail about the System Development Life Cycle (SDLC) methodology used to approach Computer System Validation (CSV), including all of the phases, sequencing of events, deliverables, and documentation requirements.

Recording Available

* Per Attendee $249

 

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

 

Data Integrity in the Pharmaceutical Laboratory: Practical Steps to Identify and Avoid Data Integrity Issues

webinar-speaker   Gregory Martin

webinar-time   90 Min

Product Id: 705347

This webinar will discuss in detail the fundamentals of data integrity including the FDA guidance document. It will teach attendees practical steps to identify and avoid data integrity issues in pharmaceutical laboratory.

Recording Available

* Per Attendee $249

 

Residual Solvents: Take Advantage of the New Flexibility in Revised USP <467>

webinar-speaker   Gregory Martin

webinar-time   90 Min

Product Id: 705325

This webinar provides understanding of the requirements for residual solvents addressed in ICH, USP, EP and JP and focus on the recent changes to USP <467>. It will also help attendees utilize strategies to minimize the testing and resources required to meet the requirements.

Recording Available

* Per Attendee $249

 

Transfer of Analytical Methods According to the USP Chapter <1224>

webinar-speaker   Dr. Ludwig Huber

webinar-time   75 Min

Product Id: 701971

This webinar will explain the final version of USP Chapter <1224> and FDA guidance for conducting and documenting method transfer between laboratories and sites, and provide tools for effective implementation.

Recording Available

* Per Attendee $249

 

 

 

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