Practical Application of 21 CFR Part 11

Instructor: Don Hurd
Product ID: 706383
  • Duration: 60 Min
Attend this webinar to get a condensed overview of 21 CFR Part 11 and the key practices that deliver the best results. It will direct you to the most critical and cost-effective methods, techniques and tools available.

recorded version

$299.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Feb-2020

Training CD / USB Drive

$399.00
One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

Why Should You Attend:

You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations that uses ER/ES capability, or if you are maintaining or supporting such a system.

Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. During the past 30 years, best practices that have been developed will ensure that validation activities are cost-effective while meeting all aspects of FDA compliance.

There is an enormous body of documentation and information available that can be overwhelming. This course will provide a condensed overview of the key practices that deliver the best results by directing the attendees to the most critical and cost-effective methods, techniques and tools available.

Learning objectives:

  • Learn about 21 CFR Part 11 and what is required for compliance
  • Learn about industry best practices related to compliance and computer system validation
  • Understand strategies for reducing the cost and complexity of compliance with FDA regulations, including 21 CFR Part 11
  • Understand how the System Development Life Cycle (SDLC) methodology supports the computer system validation process
  • Understand how to effectively document the process of computer system validation, and maintain current information about the various systems in your organization and how they are maintained in a validated state
  • Learn how to gain information about trends in validation, as industry progresses and new best practices emerge
  • Understand some of the industry best practices to apply when following the SDLC methodology

Areas Covered in the Webinar:

  • Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology
  • Good "Variable" Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP))
  • Validation Strategy that will take into account the system risk assessment process
  • FDA's 21 CFR Part 11 (Electronic Records/Electronic Signatures) Guidance
  • Strategic Approach to ER/ES Compliance
  • Policies and Procedures to support GxP compliance with 21 CFR Part 11
  • Training and Organizational Change Management best practices to help move the organization in a new direction
  • Industry best practices and common pitfalls

Recently asked question ?

  • Is Adobe application falls under Part 11?

Who Will Benefit:

  • (Bio)Pharmaceutical Companies
  • Device manufacturers
  • Manufacturers of pharmaceutical starting material
  • Clinical Laboratories
  • Software developers
  • IT managers and system administrators
  • QA managers and personnel
  • Users of computer systems in FDA regulated environments
  • Validation professionals
  • Training department
  • Documentation department
  • Consultants
Instructor Profile:
Don Hurd

Don Hurd
VP Quality and Validation Services , The Realtime Group

Don Hurd has over 35 years of experience in supporting development of applications of or containing software in regulated industries, the last 17 in medical devices. With his diverse background, Mr. Hurd provides a unique insight into driving product quality and ensuring high productivity of development organizations. Mr. Hurd is currently the Vice President of Quality and Validation Services for The Realtime Group, a contract R&D firm specialized in serving the regulated industries, primarily medical devices. In this role, Mr. Hurd led the company to certification in both ISO 9001 and ISO 13485, maintaining certification for nearly 15 years. In his role at Realtime, Mr. Hurd supports clients in efforts ranging from Quality Management System development, deployment, and remediation; product and development quality planning; verification and validation of products, product software, and non-product software; supplier qualification, approval, and management; transitioning product from development to manufacturing; supporting post-market vigilance / surveillance; and interfacing with ISO auditors and FDA inspectors. Mr. Hurd has been an ASQ Certified Quality Auditor since 2009. Mr. Hurd is active in the ASQ Biomedical Division Discussion Group, ASQ Audit Special Interest Group, and bionorthTX, holding leadership positions in each.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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