ComplianceOnline

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
Current Concepts and Challenges in Cloud Compliance
7
/ Jan
Monday-2019

Current Concepts and Challenges in Cloud Compliance

  • Speaker: Angela Bazigos
  • Product ID: 703739
  • Duration: 90 Min
Cloud computing has become perhaps the most critical compliance topic related to computer validation and electronic records. The potential economic and resource advantages to using cloud based environments guarantee that management will expect compliance strategies to be developed that will support decisions to utilize cloud environments to perform regulated activities. This presentation will provide a baseline of information related to cloud computing which will help attendees better understand the cloud concept, associated regulatory challenges, and suggestions for consideration when establishing a cloud based system.
Controlled Document System for a Life Sciences Manufacturing Plant - Principles of Lean Documents and Lean Configuration
15
/ Jan
Tuesday-2019

Controlled Document System for a Life Sciences Manufacturing Plant - Principles of Lean Documents and Lean Configuration

  • Speaker: Jose Mora
  • Product ID: 703396
  • Duration: 90 Min
This webinar will explain how to apply the theory of lean documents and its corollary theory of lean configuration to present a fresh approach to controlled document system for a life sciences manufacturing plant.
* Per Attendee
$199
Data Governance for Computer Systems Regulated by FDA
23
/ Jan
Wednesday-2019

Data Governance for Computer Systems Regulated by FDA

  • Speaker: Carolyn Troiano
  • Product ID: 704745
  • Duration: 60 Min
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.
* 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
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
Performing an Effective, Robust and Compliant Sterility Failure Investigation: How to Avoid Common Mistakes
20
/ Feb
Wednesday-2019

Performing an Effective, Robust and Compliant Sterility Failure Investigation: How to Avoid Common Mistakes

  • Speaker: Charity Ogunsanya
  • Product ID: 703885
  • Duration: 90 Min
This training program will highlight mistakes often made when corrective and preventative actions are not clearly identified and applied during a manufactured product sterility test failure investigation because an ineffective investigational procedure and tool was used to conduct a sterility test failure investigation. The webinar will also illustrate how avoiding such common mistakes will ensure that these types of products meet the sterility requirements USP <71> and other regulatory guidelines applicable to finished products, bulk drug substance, raw materials or excipients.
* Per Attendee
$199
Human Error and Cognitive Load: How to Reduce Memory and Attention Failures
26
/ Feb
Tuesday-2019

Human Error and Cognitive Load: How to Reduce Memory and Attention Failures

  • Speaker: Ginette M Collazo
  • Product ID: 704210
  • Duration: 90 Min
This training program will discuss the types of human error, the taxonomy of human error, human error reduction initiatives, individual performance, cognitive load and human error, cognitive load categories, and more.
* Per Attendee
$199
Selection and Use of (Certified) Reference Material in Analytical Laboratories
14
/ Mar
Thursday-2019

Selection and Use of (Certified) Reference Material in Analytical Laboratories

  • Speaker: Dr. Ludwig Huber
  • Product ID: 702550
  • Duration: 75 Min
This training on using certified reference material in analytical laboratories will cover FDA and international requirements for selection, purchasing, testing, storage and use of (certified) reference material.
* Per Attendee
$199
Human Error Investigations, Root Cause Determination and CAPA Effectiveness
24
/ Apr
Wednesday-2019

Human Error Investigations, Root Cause Determination and CAPA Effectiveness

  • Speaker: Ginette M Collazo
  • Product ID: 704314
  • Duration: 90 Min
This training program will offer attendees an understanding of human error, its factors and causes. The program will also identify the regulatory and business importance of human error prevention and define the process to manage human error deviations.
* Per Attendee
$199
Recorded/CD
Method Validation under Good Laboratory Practices (GLP)

Method Validation under Good Laboratory Practices (GLP)

  • Speaker: John Fetzer
  • Product ID: 703561
  • Duration: 60 Min
This laboratory compliance training will teach you how to validate an analytical method under the GLP requirements. It will cover in detail the criteria for the validation of an analytical method including statistical and documentation requirements.
CD/Recorded
$249
Recorded/CD
Data Integrity in the Pharmaceutical Laboratory: Practical Steps to Identify and Avoid Data Integrity Issues

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

  • Speaker: Gregory Martin
  • Product ID: 705347
  • Duration: 90 Min
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.
CD/Recorded
$249
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
Residual Solvents: Take Advantage of the New Flexibility in Revised USP <467>

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

  • Speaker: Gregory Martin
  • Product ID: 705325
  • Duration: 90 Min
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.
CD/Recorded
$249
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
Transfer of Analytical Methods According to the USP Chapter <1224>

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

  • Speaker: Dr. Ludwig Huber
  • Product ID: 701971
  • Duration: 75 Min
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.
CD/Recorded
$249
Recorded/CD
FDA's Ambitious Regulation of Social Media

FDA's Ambitious Regulation of Social Media

  • Speaker: Casper Uldriks
  • Product ID: 703853
  • Duration: 60 Min
FDA regulates advertising and promotion material as labeling. The legal definition of labeling covers just about anything that explicitly or implicitly conveys a message intended to affect a person’s behavior and decision outcomes. How FDA applies its legal tenants of false and misleading information or variations on that theme requires continual updating by FDA and constant re-evaluation by industry. Now the regulatory landscape involves other federal agencies and academic principles in psychology. It has become very complicated and will prove very costly if you knowingly or unknowing walk into one of FDA’s legal snares. This webinar will bring attendees up to speed so you are clearer about what is a problem, what is not a problem and what becomes a risk laden judgment call.
CD/Recorded
$279
Recorded/CD
Implementation and Management of GMP Data Integrity

Implementation and Management of GMP Data Integrity

  • Speaker: Danielle DeLucy
  • Product ID: 705029
  • Duration: 90 Min
Data integrity is the assurance that data records are accurate, complete, intact and maintained within their original context, including their relationship to other data records. This definition applies to data recorded in electronic and paper formats or a hybrid of both. To assure the quality of raw materials, in process materials and finished goods, laboratory data integrity is assuming greater importance in CGMP for US FDA regulated industry. Data integrity and security infractions are not only 21 CFR Part 11 issues but also severe CGMP violations.
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
Laboratory Investigations for Out of Specification Results

Laboratory Investigations for Out of Specification Results

  • Speaker: Barbara Berglund
  • Product ID: 702263
  • Duration: 90 Min
This 90-minute webinar on laboratory investigations will explore successful approaches to laboratory investigations of out of trend results and also explore approaches which may have potential for pitfalls.
CD/Recorded
$249
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