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
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.
CD/Recorded
$0
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
$0
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
$0
Recorded/CD
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.
CD/Recorded
$0
Recorded/CD
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.
CD/Recorded
$0
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
Recorded/CD
21 CFR Part 11 and Annex 11 Compliance - Specifics Needed to Eliminate 483s

21 CFR Part 11 and Annex 11 Compliance - Specifics Needed to Eliminate 483s

  • Speaker: David Nettleton
  • Product ID: 704533
  • Duration:
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).
CD/Recorded
$0
Recorded/CD
Current Regulatory Requirements for Aseptically Produced Products

Current Regulatory Requirements for Aseptically Produced Products

  • Speaker: Kenneth Christie
  • Product ID: 704791
  • Duration:
The manufacture of sterile products and the risk they represent to the public is always on the fore front of inspectors during regulatory audits. As a result, the manufacture of sterile products require a high degree of control of incoming materials, the manufacturing process and the control of personnel to name a few. A weakness in any of these items can jeopardize the sterility assurance of the final product. This training program will highlight and summarize the following main components relating to current validation requirements for sterile products and include the following; review of the current regulations and guidance documents, the typical expectations when aseptic processing is involved, the expectations for protocols used to document the qualification of associated equipment, utilities and processes, and recently cited regulatory deficiencies.
CD/Recorded
$0
Recorded/CD
HIPAA Compliance for Electronic Records

HIPAA Compliance for Electronic Records

  • Speaker: David Nettleton
  • Product ID: 704422
  • Duration:
This HIPAA training program will highlight electronic record security regulations including requirements for security, data transfer, audit trails, electronic signatures, digital pens, and biometric signatures.
CD/Recorded
$0
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