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
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
Recorded/CD
Establish Change Control for Pharmaceutical Stability Program

Establish Change Control for Pharmaceutical Stability Program

  • Speaker: Kim Huynh-Ba
  • Product ID: 702968
  • Duration:
This webinar on pharmaceutical stability program will discuss the types of CMC changes in the life cycle of a pharmaceutical product and how it affects the stability program.
CD/Recorded
$0
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