ComplianceOnline
Eliminate the Confusion - New Requirements for Clinical Laboratories to Meet GCP
26
/ Feb
Tuesday-2019

Eliminate the Confusion - New Requirements for Clinical Laboratories to Meet GCP

  • Speaker: Laura Brown
  • Product ID: 701947
  • Duration: 60 Min
This webinar will help clinical laboratories, analyzing samples from clinical trials, understand the compliance requirements concerning ICH GCP for FDA and EMA compliance.
* Per Attendee
$229
CDISC Mapping 1: Specifications and FDA Requirements
27
/ Feb
Wednesday-2019

CDISC Mapping 1: Specifications and FDA Requirements

  • Speaker: Sunil Gupta
  • Product ID: 704152
  • Duration: 90 Min
This training program will discuss CDISC requirements to create SDTMs and ADaMs. It will also offer essential mapping and strategy concepts for creating and validating SDTM and ADaM variables in key CDISC datasets (DM, AE, ADSL, and ADAE).
* Per Attendee
$229
FDA Compliance and Clinical Trial Computer System Validation
27
/ Feb
Wednesday-2019

FDA Compliance and Clinical Trial Computer System Validation

  • Speaker: Carolyn Troiano
  • Product ID: 705358
  • Duration: 60 Min
This webinar will discuss FDA requirements for clinical trial Computer System Validation (CSV) including System Development Life Cycle (SDLC) approach to validation. It will help attendees understand how to leverage the vendor and other external resources to apply the best industry practices and avoid potential pitfalls when validating a clinical trial system.
* Per Attendee
$229
How to Manage Your Vendors in Clinical Research
28
/ Feb
Thursday-2019

How to Manage Your Vendors in Clinical Research

  • Speaker: Pam Dellea Giltner
  • Product ID: 705958
  • Duration: 90 Min
This vendor management webinar will show you how to choose the right vendor, onboarding and set up, manage vendor performance, manage issues and ensure compliance with current FDA regulations and ICH guidelines and have a smooth-running clinical study.
* Per Attendee
$249
Current Concepts and Challenges in Cloud Compliance
28
/ 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
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
Hypothesis Testing, P-values and Inference: When Thinking like a Statistician Makes Sense
6
/ Mar
Wednesday-2019

Hypothesis Testing, P-values and Inference: When Thinking like a Statistician Makes Sense

  • Speaker: Elaine Eisenbeisz
  • Product ID: 703552
  • Duration: 120 Min
This clinical research webinar will explore the reasoning that formulates null hypotheses and turns researchers’ hair gray. Attendees will learn the why and how of the scientific method and how to view the world with a statistician’s eyes. Also attendees will learn the possibilities and limitations of research questions and hypothesis development, how to interpret statistical findings with p-values, effect sizes, and confidence intervals.
* Per Attendee
$299
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
Technical Writing for Medical Products: SOPs, Investigations and Change Records
14
/ Mar
Thursday-2019

Technical Writing for Medical Products: SOPs, Investigations and Change Records

  • Speaker: Regina Fullin
  • Product ID: 704304
  • Duration: 60 Min
In this training program, attendees will learn quick formatting tips that will make writing more readable and learn how to use formatting tools in a way to maximize the impact of their writing in an electronic system.
* Per Attendee
$229
Total Organic Carbon Analysis for Cleaning Validation in Pharmaceutical Manufacturing
22
/ Mar
Friday-2019

Total Organic Carbon Analysis for Cleaning Validation in Pharmaceutical Manufacturing

  • Speaker: Joy McElroy
  • Product ID: 705929
  • Duration: 90 Min
In this cleaning validation webinar attendees will learn the Total Organic Carbon (TOC) feasibility, method validation and transfer from the laboratory to the manufacturing floor, as well as reviewing a feasibility study of multiple, difficult to oxidise or low solubility organic compounds.
* Per Attendee
$249
Risk Based Monitoring for GCP Compliance
27
/ Mar
Wednesday-2019

Risk Based Monitoring for GCP Compliance

  • Speaker: Laura Brown
  • Product ID: 705052
  • Duration: 60 Min
This Webinar will help you how to ensure that your data and supporting documentation are in the appropriate format to comply with regulatory authority inspection. Risk based monitoring can contribute to better oversight and more efficient use of resources of clinical studies.
* Per Attendee
$229
CDISC Mapping 2: ODM, MindMaps and References
27
/ Mar
Wednesday-2019

CDISC Mapping 2: ODM, MindMaps and References

  • Speaker: Sunil Gupta
  • Product ID: 704208
  • Duration: 90 Min
This training program will highlight key differences between SDTM and ADaM models and process flows. It will also focus on key differences between the seven CDISC classes and on best practices to create Dataset.XML from SAS. Attendees will gain a better understanding of the structure and syntax of ODM-XML files as well.
* Per Attendee
$199
CDISC Mapping 3: Compare and Contrast SDTM and ADaM Steps
24
/ Apr
Wednesday-2019

CDISC Mapping 3: Compare and Contrast SDTM and ADaM Steps

  • Speaker: Sunil Gupta
  • Product ID: 704302
  • Duration: 90 Min
This training program will assist anyone directly or indirectly responsible for the creation, content or validation of CDISC data sets, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. Professionals in the pharmaceutical, biotechnology and medical device industries who want to be Good Clinical Practices (GCP) compliant in relation to regulatory submission environment will benefit from this training. Effective and practical solutions to address real-world issues will be detailed.
* Per Attendee
$199
Recorded/CD
Surviving an FDA Sponsor Inspection - Training for Success

Surviving an FDA Sponsor Inspection - Training for Success

  • Speaker: Stephen Schwartz
  • Product ID: 704516
  • Duration: 105 Min
This training program will review a case study derived from actual inspections wherein FDA performed a sponsor site inspection having already audited three of the investigator sites. FDA was aware from these site audits of potential serious noncompliance issues. The course will also discuss Sponsor/CRO/investigator relationship issues from these three site audits.
CD/Recorded
$429
Recorded/CD
Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan

Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan

  • Speaker: Robert J Russell
  • Product ID: 705370
  • Duration: 90 Min
This webinar will focus on the key regulatory requirements for medical devices for the participating MDSAP countries of U.S., Canada, Brazil, Australia and Japan. It will address key topics such as device classification, licensing pathways, medical device GMP, inspections, device labeling, license holder responsibilities and more.
CD/Recorded
$249
Recorded/CD
Risk Based Approaches for Clinical Trials

Risk Based Approaches for Clinical Trials

  • Speaker: Laura Brown
  • Product ID: 705858
  • Duration: 90 Min
This risk based clinical trial webinar will explain the importance of using risk management techniques in clinical research to comply with the latest focus on GCP inspection. It will show you how risk management can improve the quality of your clinical trials and demonstrate the importance of using risk analysis and risk management techniques in clinical trials.
CD/Recorded
$199
Recorded/CD
Data Governance for Computer Systems Regulated by FDA

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.
CD/Recorded
$249
Recorded/CD
Tips and Techniques for Handling Missing Data (Statistical Techniques)

Tips and Techniques for Handling Missing Data (Statistical Techniques)

  • Speaker: Elaine Eisenbeisz
  • Product ID: 705889
  • Duration: 120 Min
Join Elaine Eisenbeisz for a 2-hour webinar as she presents some history behind the many ways of dealing with missing data. She will provide some statistical reasoning on the why and when of applying various techniques in working with missing-ness in data. Elaine will also discuss and demonstrate multiple imputation techniques using SPSS software.
Recorded/CD
Power Analysis for Sample Size Calculations

Power Analysis for Sample Size Calculations

  • Speaker: Elaine Eisenbeisz
  • Product ID: 705873
  • Duration: 120 Min
In this webinar attendees will learn the statistical power analysis and techniques for determining sample size (a priori techniques) calculation. Also attendees will get work examples in the free to use G*Power software. Some code and demonstrations will be provided for powering studies and performing power analysis simulations in R software.
CD/Recorded
$249
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