ComplianceOnline

FDA Validation Requirements Regulatory Compliance Training - Live Webinars, Recordings & CDs

Recorded/CD
Best Practices for an Effective Cleaning Validation Program

Best Practices for an Effective Cleaning Validation Program

  • Speaker: Joy McElroy
  • Product ID: 704329
  • Duration: 60 Min
This training program will be beneficial to personnel directly involved in the development of cleaning procedures, cleaning validation programs and plans. Additionally, those responsible for cleaning validation protocols and execution activities, including validation and laboratory personnel, as well as, beginning or seasoned operational personnel who will eventually participate in such efforts, will find this course particularly useful.
CD/Recorded
$299
Recorded/CD
How to Prepare a Standard Operating Procedure (SOP)?

How to Prepare a 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.
CD/Recorded
$299
Recorded/CD
Good Laboratory Practices (GLPs) - Comparing and Contrasting with Good Manufacturing Practices (GMPs)

Good Laboratory Practices (GLPs) - Comparing and Contrasting with Good Manufacturing Practices (GMPs)

  • Speaker: Joy McElroy
  • Product ID: 704086
  • Duration: 120 Min
The objective of this webinar is to compare and contrast between Good Laboratory Practices and Good Manufacturing practices.
CD/Recorded
$349
Recorded/CD
Steam Sterilization Microbiology and Autoclave Performance Qualification

Steam Sterilization Microbiology and Autoclave Performance Qualification

  • Speaker: Danielle DeLucy
  • Product ID: 705027
  • Duration: 60 Min
In this webinar, the steam sterilization mechanism will be described as it relates to bacterial cells and endospores. The process and key terminology are defined. Understanding these fundamentals is critical to develop a successful autoclave sterilization process.
CD/Recorded
$299
Recorded/CD
Sterilization of Pharmaceutical Products and Medical Devices

Sterilization of Pharmaceutical Products and Medical Devices

  • Speaker: Carl Patterson
  • Product ID: 705310
  • Duration: 90 Min
This webinar will discuss in detail the methods of sterilization to be used on medical devices and pharmaceutical products including advantages and disadvantages of each method. Also attendees will understand the regulations pertaining to sterilization of products that will help to decide with method to use for their product. Validation of each sterilization method will be discussed and how best to prove to a regulatory body the products being treated are considered sterile.
CD/Recorded
$299
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
Attend this webinar to learn the regulatory expectations for data integrity during CGMP inspections. The course will review examples of data integrity pitfalls, part 11 compliance data integrity issues, FDA citations related to data integrity. It will teach you how to improve data integrity in a laboratory environment.
CD/Recorded
$299
Recorded/CD
21 CFR 11 Compliance for Excel Spreadsheet

21 CFR 11 Compliance for Excel Spreadsheet

  • Speaker: Angela Bazigos
  • Product ID: 702450
  • Duration: 90 Min
This Excel spreadsheet compliance training will outline the FDA requirements for Excel spreadsheets used in regulated environments and provide guidance on 21 CFR Part 11 validation.
CD/Recorded
$249
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
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
Verification vs. Validation in FDA Regulated Industries

Verification vs. Validation in FDA Regulated Industries

  • Speaker: John Chapman
  • Product ID: 700828
  • Duration: 60 Min
This webinar on verification vs. validation will help you to understand the differences between, and benefits of, verification and validation in both design and process operations in regulated industries. Learn about the risks and complications involved with the application of sound verification and validation principles.
CD/Recorded
$249
Recorded/CD
Drafting a Software Verification and Validation Report Package and Protocol - The 11 Must-have Documents

Drafting a Software Verification and Validation Report Package and Protocol - The 11 Must-have Documents

  • Speaker: John E Lincoln
  • Product ID: 704848
  • Duration: 90 Min
A tougher U.S. FDA expects a company to maintain certain documents in equipment, process and product software V&V. These documentation requirements can assist in a 21 CFR Part 11 CGMP records / signature V&V as well. This training program will provide valuable assistance to all regulated companies in evaluating their existing or anticipated software V&V activities and documentation requirements, especially in light of the changes in the FDA's stance vis a vis industry compliance, past problems, and the growing cloud environment. It will help attendees understand and recognize the most common software V&V failings and their fixes. The webinar will allow attendees to develop and use a repeatable software V&V template for all software validation projects.
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
Learning from Recent FDA Warning Letters Related to Part 11 and Computer Validation

Learning from Recent FDA Warning Letters Related to Part 11 and Computer Validation

  • Speaker: Dr. Ludwig Huber
  • Product ID: 701547
  • Duration: 75 Min
This webinar focuses on 21 CFR Part 11 requirements stipulated by the FDA. It will also guide attendees on writing corrective and preventive action plans as follow up to 483s.
CD/Recorded
$249
Recorded/CD
Computer System Validation: Step-by-Step

Computer System Validation: Step-by-Step

  • Speaker: Dr. Ludwig Huber
  • Product ID: 701673
  • Duration: 75 Min
Learn computer system validation essentials and eight fundamental steps of implementation for cost saving. Get complementary SOPs and checklists for easy implementation. Understand the structure of validation plan, documentation of ongoing performance, and structure of validation report.
CD/Recorded
$249
Recorded/CD
Good Practices for Data Integrity, the new Guidance and one FDA Inspector's Experience

Good Practices for Data Integrity, the new Guidance and one FDA Inspector's Experience

  • Speaker: John R Godshalk
  • Product ID: 704806
  • Duration: 60 Min
This webinar, by an ex-FDA, will cover Good Data Integrity Practice for GxP environments. Participants will understand what FDA looks for with regard to data integrity, what may need to be audited, the new guidance and application of data integrity, and relevant regulations for data integrity
CD/Recorded
$249
Recorded/CD
Computer System Validation and Part 11 Compliance

Computer System Validation and Part 11 Compliance

  • Speaker: Joy McElroy
  • Product ID: 705427
  • Duration: 60 Min
This webinar will discuss in detail the requirements of 21 CFR part 11 and updated European Annex 11 regulation including requirements for local, SaaS, and cloud hosting. It will also offer techniques to implement a computer system using risk-based validation to gain maximum productivity and reduce cost by as much as two thirds.
Recorded/CD
Understanding and Implementing USP <1058>: Analytical Instrument Qualification

Understanding and Implementing USP <1058>: Analytical Instrument Qualification

  • Speaker: Dr. Ludwig Huber
  • Product ID: 700067
  • Duration: 75 Min
This Analytical Instrument Qualification training will guide you through Understanding of draft for analytical instrument qualification - Essential steps and recommendations for firmware and software validation.
CD/Recorded
$249
Recorded/CD
How to Select and Manage Vendors in a Regulated Environment (incl. ICH E6)

How to Select and Manage Vendors in a Regulated Environment (incl. ICH E6)

  • Speaker: Angela Bazigos
  • Product ID: 705488
  • Duration: 90 Min
Buying software is a fact of life for most companies. There is fierce competition in the market, with multiple software vendors trying to convince to buy their product. How do you determine whether to buy the software or having it built in house? Or which vendor to choose? And if you buy something, how do you determine whether to have it hosted? And are there any regulations that apply to this software? And if so, what are they?
Recorded/CD
Implementing a Bullet Proof Quality System for FDA Audit Success

Implementing a Bullet Proof Quality System for FDA Audit Success

  • Speaker: Meena Chettiar
  • Product ID: 705400
  • Duration: 60 Min
This webinar will provide an overview of the FDA expectations in medical device industries for setting up a quality system for FDA audit readiness. It will also provide an understanding of the quality system inspection techniques (QSIT) requirements for documents controls, production and process controls, packaging and labeling controls and more.
Recorded/CD
How to Conduct a Human Factors Validation Following ISO 62366 and the 2016 FDA Guidance

How to Conduct a Human Factors Validation Following ISO 62366 and the 2016 FDA Guidance

  • Speaker: Edwin Waldbusser
  • Product ID: 705057
  • Duration: 60 Min
This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/ usability validation. HF/U validation is very different from device validation. For example, success criteria is qualitative rather than quantitative as is in device validation. Claiming success because e.g. 95% of test participants did not commit a user error is not valid. Nor is 100% positive test results sufficient.
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