ComplianceOnline

Laboratory Regulations and Guidance Training - Live Webinars, Recordings & CDs

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 laboratory challenges in clinical laboratory.
* Per Attendee
$229
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
$249
Current Concepts and Challenges in Cloud Compliance
21
/ Feb
Thursday-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.
* Per Attendee
$229
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
$229
FDA Regulations for Environmental Monitoring (EM) Program
4
/ Mar
Monday-2019

FDA Regulations for Environmental Monitoring (EM) Program

  • Speaker: Joy McElroy
  • Product ID: 704377
  • Duration: 90 Min
This training program on applicable regulations pertaining to clean room environmental monitoring (EM) programs will discuss the basics of setting a robust and effective EM program. The course will also detail the relationship between an EM Excursion Program and CAPA and the four phases of clean room transitional monitoring.
* Per Attendee
$199
Root Cause Analysis - The Heart of Corrective Action
5
/ Mar
Tuesday-2019

Root Cause Analysis - The Heart of Corrective Action

  • Speaker: Betty Lane
  • Product ID: 703391
  • Duration: 75 Min
This webinar will discuss how root cause is an essential part of a corrective action system and will provide some examples of how to perform root cause analysis.
* Per Attendee
$199
The Most Serious FDA 483s - How to Avoid Them
12
/ Mar
Tuesday-2019

The Most Serious FDA 483s - How to Avoid Them

  • Speaker: John E Lincoln
  • Product ID: 702766
  • Duration: 90 Min
This webinar on avoiding serious FDA 483s will explain FDA's changed audit focus based on recent top 483 findings and provide practical tips on how to better prepare your company's internal audit program to avoid serious Form 483 observations.
* Per Attendee
$249
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
Guideline to Aseptic Technique and Clean Room Behavior
28
/ Mar
Thursday-2019

Guideline to Aseptic Technique and Clean Room Behavior

  • Speaker: Danielle DeLucy
  • Product ID: 704429
  • Duration: 60 Min
This training program will discuss how, in sterile compounding, aseptic technique is contributing to the prevention of microbiological contamination. It provides sterility, safety, and efficacy to the sterile product, especially various injections for patients. In this course, cleaning, gowning and proper methods of contamination control will be reviewed along with why clean rooms are designed the way they are.
* Per Attendee
$229
QbD Approach to Analytical Method Lifecycle: Design, Development, Validation and Transfer
28
/ Mar
Thursday-2019

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

  • Speaker: Gregory Martin
  • Product ID: 703644
  • Duration: 90 Min
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.
* 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
Assay Validation for Clinical Diagnostics

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.
CD/Recorded
$249
Recorded/CD
Validation and Use of Cloud Computing in FDA Regulated Environments

Validation and Use of Cloud Computing in FDA Regulated Environments

  • Speaker: Dr. Ludwig Huber
  • Product ID: 703423
  • Duration: 75 Min
This webinar will discuss FDA requirements related to cloud computing. It will provide step-by-step recommendations for using 'clouds' from planning to reporting.
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
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
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
Good Documentation Guideline (Chapter <1029> USP)

Good Documentation Guideline (Chapter <1029> USP)

  • Speaker: Dr. Afsaneh Motamed Khorasani
  • Product ID: 705130
  • Duration: 60 Min
This webinar will familiarize participants with USP Chapter <1029> on good documentation guidelines. This session will wrap up the general concept and will provide information as to what needs to be documented in certain records.
CD/Recorded
$249
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