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
Project Management for Computer Systems Validation
26
/ Feb
Tuesday-2019

Project Management for Computer Systems Validation

  • Speaker: Angela Bazigos
  • Product ID: 702493
  • Duration: 90 Min
This computer system validation training will highlight the principles of project management that can be applied to 21 CFR Part 11 compliance for Computer Systems Validation and show how you can use project management tenets to deliver on time and on budget, while meeting FDA regulatory compliance requirements.
* Per Attendee
$299
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
21 CFR Part 11 and Annex 11 Compliance; Specifics for Data Integrity with SaaS/Cloud
28
/ Feb
Thursday-2019

21 CFR Part 11 and Annex 11 Compliance; Specifics for Data Integrity with SaaS/Cloud

  • Speaker: David Nettleton
  • Product ID: 701687
  • Duration: 90 Min
This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features and validation (10 step risk based approach).
* Per Attendee
$229
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
Laboratory Inspection Readiness - Implementing GMPs for the Pharmaceutical Laboratory
4
/ Mar
Monday-2019

Laboratory Inspection Readiness - Implementing GMPs for the Pharmaceutical Laboratory

  • Speaker: Gregory Martin
  • Product ID: 702534
  • Duration: 90 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
$299
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
Batch Record Review and Product Release
5
/ Mar
Tuesday-2019

Batch Record Review and Product Release

  • Speaker: Danielle DeLucy
  • Product ID: 705921
  • Duration: 60 Min
In this webinar attendees will learn the fundamentals for reviewing batch records in a pharmaceuticals, biologics and medical devices environment. You will hear about the proper training that must be demonstrated before one is considered a suitable reviewer of these critical documents and you will learn how to react to discrepancies found in these records.
* Per Attendee
$179
How to Write Effective 483 and Warning Letter Responses
5
/ Mar
Tuesday-2019

How to Write Effective 483 and Warning Letter Responses

  • Speaker: Kelly Thomas
  • Product ID: 705918
  • Duration: 90 Min
In this regulatory inspection webinar attendees will learn the importance of developing and submitting a robust, timely response to FDA 483 observations or warning letters; as well as, educate the audience on the essential elements of a thorough response. Also attendees will learn the proper structure of the response to ensure the regulatory agency’s expectations are met and the submission process is properly understood.
* Per Attendee
$199
Quality Risk Management Overview for Pharma, Biopharma and Combination Products - ICH Q9/ISO 14971
6
/ Mar
Wednesday-2019

Quality Risk Management Overview for Pharma, Biopharma and Combination Products - ICH Q9/ISO 14971

  • Speaker: Tanvir Mahmud
  • Product ID: 702422
  • Duration: 60 Min
This 60-minute webinar will cover principles and provide examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality. It will provide you with the knowledge and understanding needed to improve patient safety and also to prepare your organization for regulatory inspections.
* Per Attendee
$199
Supplier and Service Provider Controls: FDA Expectations
6
/ Mar
Wednesday-2019

Supplier and Service Provider Controls: FDA Expectations

  • Speaker: Vanessa Lopez
  • Product ID: 704844
  • Duration: 120 Min
This training program will provide regulatory requirements (US) of 21 CFR Section 820.50 (purchasing control) for the medical device industry and illustrate the same with examples. It will furnish details on what purchasing/supplier control management systems should address.
* Per Attendee
$249
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
Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance
13
/ Mar
Wednesday-2019

Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance

  • Speaker: David Nettleton
  • Product ID: 701582
  • Duration: 75 Min
Learn how to use Microsoft Excel spreadsheets for GXP data to ensure compliance with 21 CFR Part 11 and reduce validation cost and time.
* Per Attendee
$199
Risk Analysis in Medical Device Design
14
/ Mar
Thursday-2019

Risk Analysis in Medical Device Design

  • Speaker: Charles H Paul
  • Product ID: 704803
  • Duration: 60 Min
This medical device risk assessment webinar will discuss the regulatory requirements and the processes, tools and techniques for conducting an effective device Risk or Hazard Analysis.
* Per Attendee
$229
Recorded/CD
Introduction to Root Cause Investigation for CAPA

Introduction to Root Cause Investigation for CAPA

  • Speaker: Vanessa Lopez
  • Product ID: 704409
  • Duration: 60 Min
This CAPA training program will provide an understanding of FDA and ISO requirements, steps in CAPA process and the challenges associated to root cause analysis. Attendees will learn the tools and quality data sources to use during root cause analysis investigation.
CD/Recorded
$299
Recorded/CD
Pharmacokinetics/Biopharmaceutics for Chemists/Analysts

Pharmacokinetics/Biopharmaceutics for Chemists/Analysts

  • Speaker: Saeed Qureshi
  • Product ID: 705271
  • Duration: 120 Min
This training program will focus on defining and explaining numerous concepts and terminologies in a simple language as related to the safety, efficacy and quality assessment of pharmaceutical products for human use. It will also describe the necessity of understanding the basic physiological concepts pertinent to drug actions, product developments and evaluations.
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
Performing an Effective, Robust and Compliant Sterility Failure Investigation: How to Avoid Common Mistakes

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.
CD/Recorded
$299
Recorded/CD
Validation and Use of Excel® Spreadsheets in FDA Regulated Environments

Validation and Use of Excel® Spreadsheets in FDA Regulated Environments

  • Speaker: Dr. Ludwig Huber
  • Product ID: 701242
  • Duration: 75 Min
This excel validation training / webinar will demonstrate how to design spreadsheets for Part 11/GxP /SOX/HIPAA compliance. And how to document planning, specifications, installation, testing and changes to meet FDA requirements.
CD/Recorded
$299
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