ComplianceOnline

Good Laboratory Practice 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
Laboratory Inspection Readiness - Implementing GMPs for the Pharmaceutical Laboratory
31
/ Jan
Thursday-2019

Laboratory Inspection Readiness - Implementing GMPs for the Pharmaceutical Laboratory

  • Speaker: Gregory Martin
  • Product ID: 702534
  • Duration: 120 Min
This 2-hr laboratory inspection webinar will discuss strategies to implement before your laboratory is about to undergo a pre-approval inspection or a general GMP inspection. It will help you gain an understanding of the key areas that are likely to be the subject of a laboratory inspection.
* Per Attendee
$199
Recorded/CD
Ensuring Integrity and Security of Laboratory Data

Ensuring Integrity and Security of Laboratory Data

  • Speaker: Dr. Ludwig Huber
  • Product ID: 702454
  • Duration: 75 Min
This webinar will provide a comprehensive understanding of the key FDA/EU requirements for integrity and security of laboratory data and offer recommendations and tools for effective implementation.
CD/Recorded
$249
Recorded/CD
Root Cause Analysis (RCA) in the Laboratory - Addressing Non-Conformances

Root Cause Analysis (RCA) in the Laboratory - Addressing Non-Conformances

  • Speaker: Michael Brodsky
  • Product ID: 704861
  • Duration: 60 Min
This RCA webinar will define a specific set of steps and associated tools that you can use to determine the primary cause of non-conformance in your laboratory. You will learn to determine what happened, why it happened and how to reduce the likelihood of that non-conformance happening again.
CD/Recorded
$249
Recorded/CD
Validation of GC / GC-MS Methodologies

Validation of GC / GC-MS Methodologies

  • Speaker: John Fetzer
  • Product ID: 705259
  • Duration: 60 Min
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.
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
Validation of HPLC/UPLC Methodologies

Validation of HPLC/UPLC Methodologies

  • Speaker: John Fetzer
  • Product ID: 705291
  • Duration: 60 Min
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.
CD/Recorded
$229
Recorded/CD
Laboratory Accreditation: Getting there is Just the Beginning

Laboratory Accreditation: Getting there is Just the Beginning

  • Speaker: Michael Brodsky
  • Product ID: 703285
  • Duration: 60 Min
This training on laboratory accreditation will focus on ISO/IEC 17025 requirements. Attendees will learn how to develop and maintain a quality management system to ensure compliance with the international laboratory accreditation standard.
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
ISO/IEC 17025:2017 Update: Everything Old is New Again

ISO/IEC 17025:2017 Update: Everything Old is New Again

  • Speaker: Michael Brodsky
  • Product ID: 705272
  • Duration: 60 Min
This training program will discuss in details the new requirements of ISO/IEC 17015:2017 laboratory accreditation standard and their impact on quality management system. Learn best practices to ensure compliance to minimize corrective actions arising from accreditation audits.
CD/Recorded
$229
Recorded/CD
Ensure successful FDA/Global Site Inspections and Maximize Potential Regulatory Opportunities by establishing effective Pharmaceutical Quality System (per ICH Q10 guidance document)

Ensure successful FDA/Global Site Inspections and Maximize Potential Regulatory Opportunities by establishing effective Pharmaceutical Quality System (per ICH Q10 guidance document)

  • Speaker: Stephanie Cooke
  • Product ID: 705477
  • Duration: 90 Min
This webinar will discuss the requirements for handling deviation based on GMPs, ICH guidance documents and other relevant guidance. It will also explain ICH Q8, Q9, and Q10 guidance documents and will provide best practices to ensure compliance with these documents in regards to handling deviations and nonconforming products.
Recorded/CD
Selection and Auditing of Analytical Contract Laboratories:  Best Practices for Pharmaceutical Scientists

Selection and Auditing of Analytical Contract Laboratories: Best Practices for Pharmaceutical Scientists

  • Speaker: Daniel Norwood
  • Product ID: 705169
  • Duration: 90 Min
This webinar on selection and auditing of analytical contract laboratories will guide the participants to understand the process of CRO selection for analytical testing. Attendees will gain knowledge on the basic principles of quality auditing of a CRO; including audit planning, scheduling, conducting an audit, and the audit report process.
CD/Recorded
$249
Recorded/CD
Laboratory Accreditation and Quality Management Systems Part 2: Technical Concerns

Laboratory Accreditation and Quality Management Systems Part 2: Technical Concerns

  • Speaker: Michael Brodsky
  • Product ID: 705299
  • Duration: 60 Min
This laboratory accreditation training program will focus on technical components of Quality Management System (QMS) including accommodation and environmental conditions, test and calibration methods, equipment, measurement traceability, sampling and much more.
Recorded/CD
Laboratory Accreditation and Quality Management Systems Part 1: Management Concerns

Laboratory Accreditation and Quality Management Systems Part 1: Management Concerns

  • Speaker: Michael Brodsky
  • Product ID: 705298
  • Duration: 90 Min
This training program will cover the requirements of ISO/IEC 17025 laboratory accreditation standard. It will focus on management components of QMS including document control, quality system, service to customer, internal audits and much more.
Recorded/CD
Managing GLP Studies in Non-GLP Facilities

Managing GLP Studies in Non-GLP Facilities

  • Speaker: Anne E Maczulak
  • Product ID: 702342
  • Duration: 90 Min
This 90-minute webinar will help you understand when a new product being developed begins to fall under the umbrella of a regulated study, teach you the basic principles of GLP study to better separate regulated activities from basic research, provide practical tips on how to keep GLP-related materials separate from non-GLP materials, and manage equipment designated for GLP use.
CD/Recorded
$199
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
Contamination Control in Pharmaceutical, Biotech and Medical Device Cleanroom

Contamination Control in Pharmaceutical, Biotech and Medical Device Cleanroom

  • Speaker: Jim Polarine
  • Product ID: 705078
  • Duration: 90 Min
This 90-minute webinar will cover general considerations for microbial control for non-sterile manufacturing areas, including attributes of an effective cleaning and disinfection program. Points to consider specifically aimed at oral solid dose (OSD) manufacturers will also be presented, including cleaning and disinfection of both product contact and non-product contact surfaces.
Recorded/CD
Risk of Presence of Objectionable Microorganisms in Biopharmaceutical Production

Risk of Presence of Objectionable Microorganisms in Biopharmaceutical Production

  • Speaker: Henry Urbach
  • Product ID: 705072
  • Duration: 90 Min
This webinar you will discuss how to help your organization get a better handle on what is an “objectionable microorganism, ” exactly how “objectionable” it really is and what you can do to minimize the risk if you find one in your process or product.
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
Effective Deviation Investigators Under GMP

Effective Deviation Investigators Under GMP

  • Speaker: David L Chesney
  • Product ID: 704974
  • Duration: 120 Min
This 120 minute training course will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA. Learn how to identify and avoid potential pitfalls during deviation investigations.
CD/Recorded
$299
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