ComplianceOnline

Regulatory Affairs Training - Live Webinars, Recordings & CDs

Hundreds of regulatory affairs specialists each year use ComplianceOnline courses to learn skills and get a clear understanding of specific regulatory requirements needed to succeed in their role. On this page, you will find a broad range of courses specially designed for you. Whether you work in the pharmaceutical, medical device, and equipment, biotechnology, cosmetics, research, or regulatory agencies, or within legal, marketing, and scientific consulting firms, you can get acquainted with the regulatory requirements and guidance for your industry. With the knowledge you gain, you will learn how to apply the regulations in a compliant manner into the actual materials that your company manufactures. You will be in a better position to understand the risks your organization faces. You will get a robust understanding of compliance within the scope of your duties. With the knowledge you gain, you can evaluate current practices and make improvements where necessary. Join them!

Recorded/CD
The Regulatory Expectations for Environmental Monitoring Programs

The Regulatory Expectations for Environmental Monitoring Programs

  • Speaker: Kenneth Christie
  • Product ID: 703648
  • Duration:
Understand the importance of an effective environmental monitoring (EM) program and its place in your organization. This course will provide insights on regulatory requirements governing EM programs, contamination control practices, and common deficiencies cited by regulatory auditors when auditing EM programs.
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$0
Recorded/CD
Challenges of an Effective Change Control Program

Challenges of an Effective Change Control Program

  • Speaker: Kenneth Christie
  • Product ID: 704638
  • Duration:
This training program will provide attendees with a better understanding of current Quality System Regulations (QSR) require companies to maintain qualified equipment, utilities and facilities in a state of control. When changes are made to these items, the change must be documented, explained as to what will be done and the items that may be impacted. This webinar will also highlight what is expected, what to include in procedures and address the challenges faced by industry in trying to establish an effective and manageable program.
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Auditing Business Continuity Plans According to ISO 22301

Auditing Business Continuity Plans According to ISO 22301

  • Speaker: Michael C Redmond
  • Product ID: 704410
  • Duration:

This training will cover the best practices for implementing and auditing a Business Continuity Plan. The speaker will discuss the lifecycle of a BCP program with specific emphasis on Risk Assessment and Business Impact Analysis, Designing a living BCP & Testing & Maintenance. The program will also detail the various standards from FFIEC to ISO. Participants will understand what’s involved in a full BCP program and have insights based upon field experience that can be applied to Internal Audit work and BCP. The session will provide you with tools that you can bring back to your company to improve upon BCP programs & ability to audit them to provide targeted recommendations.

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Basic Requirements for IQ, OQ and PQ Protocols

Basic Requirements for IQ, OQ and PQ Protocols

  • Speaker: Kenneth Christie
  • Product ID: 704591
  • Duration:
This training program will provide an outline of the typical protocols used for documentation of qualification activities, the type of information normally included in each and the common deficiencies cited when audited. It will highlight the importance of establishing specifications for all test challenges, proper documentation with regards to results obtained, how to address deviations encountered and how best to summarize results obtained.
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4-Hr Virtual Training: Ten Steps to Data Integrity in Pharmaceutical and Biotech Labs

4-Hr Virtual Training: Ten Steps to Data Integrity in Pharmaceutical and Biotech Labs

  • Speaker: Nanda Subbarao
  • Product ID: 704730
  • Duration:
This training program will provide an introduction to regulatory expectations for data integrity, discuss generation, review and archiving of data, enumerate evolving requirements for eData, and expound on support systems for data integrity.
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Excursion Studies to Support Transporting and Distributing Clinical and Commercial Products

Excursion Studies to Support Transporting and Distributing Clinical and Commercial Products

  • Speaker: Kim Huynh-Ba
  • Product ID: 704421
  • Duration:
This training program will highlight the key factors that affect stability profile of pharmaceutical products. Participants will learn how to make plan for extreme environments for transporting and distributing pharmaceutical products.
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Annual Analytical Laboratory Data Integrity Training

Annual Analytical Laboratory Data Integrity Training

  • Speaker: Nanda Subbarao
  • Product ID: 705326
  • Duration:
This webinar will address the key elements of regulatory expectations for analytical laboratory data integrity. It will teach best practices to avoid 483s and warning letters issued by FDA related to data integrity issues.
CD/Recorded
$0
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Pack of two courses: The essentials of Food and Drug Administration Medical Device Regulations: A primer for manufacturers and suppliers

Pack of two courses: The essentials of Food and Drug Administration Medical Device Regulations: A primer for manufacturers and suppliers

  • Speaker: Edwin L Bills
  • Product ID: 700957
  • Duration:
This pack of 2 courses contains the essentials of FDA Medical Device regulations.
CD/Recorded
$349
Recorded/CD
Avoiding FDA observations: Do's and Don'ts during Laboratory Inspections

Avoiding FDA observations: Do's and Don'ts during Laboratory Inspections

  • Speaker: Kim Huynh-Ba
  • Product ID: 703278
  • Duration:
This training will provide the attendees best practices for handling FDA inspections to avoid form 483 and Warning Letters.
CD/Recorded
$0
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How to Buy COTS Software, and Audit and Validate Vendors

How to Buy COTS Software, and Audit and Validate Vendors

  • Speaker: David Nettleton
  • Product ID: 703820
  • Duration:
This training program will focus on instructing attendees on best practices for buying COTS (Commercial Off-The-Shelf) software and to evaluate a software vendor. It will also highlight key data and systems subject to Part 11, and list requirements for IT, SaaS, and cloud hosting.
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GMP Requirements for Validation and Re-Validation of Analytical Procedures

GMP Requirements for Validation and Re-Validation of Analytical Procedures

  • Speaker: Kim Huynh-Ba
  • Product ID: 703041
  • Duration:
This webinar will explain the cGMP and ICH validation requirements for analytical procedures and discuss key factors that would affect validation process of analytical procedures. It will review the differences between validation and re-validation plan.
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Quality Metrics and the Issues with the FDA’s Revision Draft Guidance Quality Metrics Data

Quality Metrics and the Issues with the FDA’s Revision Draft Guidance Quality Metrics Data

  • Speaker: Barry A Friedman
  • Product ID: 705452
  • Duration:
This webinar will discuss the main issues with FDA’s revised draft guidance on submission of quality metrics data. It will also cover the most common observations that the FDA issues within the warning letter and how these can impact your organization.
CD/Recorded
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Recorded/CD
Stability Program for Pharmaceuticals and Biologics

Stability Program for Pharmaceuticals and Biologics

  • Speaker: Nanda Subbarao
  • Product ID: 705455
  • Duration:
This webinar will provide an overview of the stability studies required for pharmaceuticals and biologics. It will also provide a summary of recent developments in the industry and regulatory requirements in this field.
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Recorded/CD
Managing your GMP Quality Control (QC) Labs in Compliance with FDA Regulations

Managing your GMP Quality Control (QC) Labs in Compliance with FDA Regulations

  • Speaker: Kim Huynh-Ba
  • Product ID: 705081
  • Duration:
This webinar will discuss the common deficiencies in relation to compliance and validation issues that typically found with pharmaceutical Quality Control labs.
CD/Recorded
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Recorded/CD
The New Part 11 Inspections: Requirements for Validation and SaaS/Cloud Applications

The New Part 11 Inspections: Requirements for Validation and SaaS/Cloud Applications

  • Speaker: David Nettleton
  • Product ID: 704734
  • Duration:
This training program will identify data and systems subject to Part 11 and Annex 11. It will also decode what the regulations mean and illustrate the current computer system industry standards for security, data transfer, and audit trails.
CD/Recorded
$0
Recorded/CD
Studies to Support Temperature Excursions and Shipping of Pharmaceutical Products

Studies to Support Temperature Excursions and Shipping of Pharmaceutical Products

  • Speaker: Kim Huynh-Ba
  • Product ID: 704770
  • Duration:
Upon completion of this training program, attendees will learn key factors that would affect the shipping and distribution of drug products. One must understand the product stability profile, typical environmental conditions for storage and anticipating environmental extremes for distribution. These data will be necessary to design shipping conditions in order to maintain quality of the drug product through expiry.
CD/Recorded
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Establish an Effective Change Management Process for Stability Studies

Establish an Effective Change Management Process for Stability Studies

  • Speaker: Kim Huynh-Ba
  • Product ID: 704085
  • Duration:
Upon completion of this training program, attendees will learn key elements of a change management process, identify key indicators of change and learn the regulatory requirements for change control. This session will also discuss different observations due to the lack of effective change control program.
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Annual GLP Refresher Course - 4 Hour Virtual Training

Annual GLP Refresher Course - 4 Hour Virtual Training

  • Speaker: Nanda Subbarao
  • Product ID: 704893
  • Duration:
An Annual GLP training is a requirement for all personnel involved in Good Laboratory Practices (GLP) studies. The webinar course serves both as an initial training for new employees, new to GLP concepts will serving as a refresher course for experienced senior employees. The webinar provides an overview of the GLP to remind the attendees of the regulatory requirements for organizations in which bioanalytical testing is conducted.
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Recorded/CD
Webinar - Latin America – Understanding Regulatory Compliance Requirements Across Life Science Industry PART I & PART II

Webinar - Latin America – Understanding Regulatory Compliance Requirements Across Life Science Industry PART I & PART II

  • Speaker: Robert J Russell
  • Product ID: 701350
  • Duration:
This Latin America Regulatory compliance requirement training/webinar will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Latin America.
CD/Recorded
$299
Recorded/CD
Japanese PAL – JPAL Technical, cultural and language challenges when dealing with MAH, PMDA, Distributors and Customers

Japanese PAL – JPAL Technical, cultural and language challenges when dealing with MAH, PMDA, Distributors and Customers

  • Speaker: Phil Smart
  • Product ID: 701292
  • Duration:
This (JPAL) Japanese Pharmaceutical Affairs Law training will go into the unique challenges facing the Foreign Manufacturer when working with the Japanese.
CD/Recorded
$0
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