COURSE DESCRIPTION:

This webinar describes the validation planning process with particular emphasis on avoiding the six common pitfalls.

Increased use of software from automated manufacturing and quality systems means increased exposure. Most recalls can be traced back to computerized equipment, exposing the validation process to scrutiny. Corporate uncertainty leads to inaction and “wheel spinning.” Many companies struggle with understanding how to avoid major mistakes when validating software according to FDA standards.

This 2-hour webinar will help you understand and recognize the most common software verification and validation failings and their fixes. You will learn how to develop and use a repeatable software verification and validation template for all your software validation projects.

AREAS COVERED:

• Which data and systems are subject to 21 CFR Part 11 and Annex 11
• Why compliance makes good business sense
• Details of FDA regulations/system features as applied to software: security, audit trails, electronic signatures
• Requirements for local, SaaS, and cloud hosting
• The 6 Most Common Problems in FDA Software Validation & Verification
• Strategies on how to avoid the most common problems
• Advice on successful validation project staffing
• Avoid 483 and Warning Letters

WHY SHOULD YOU ATTEND:

This webinar will provide valuable assistance to all regulated companies in evaluating their existing or anticipated software verification and validation activities and documentation requirements, especially in light of FDA’s stricter stance with regard to compliance, past challenges, and the ubiquitous “cloud” environment.

WHO WILL BENEFIT:

This webinar is intended for professionals in the Medical Device, Biotechnology, and Pharmaceutical Industries. Personnel in the following roles will benefit:

• System owners – responsible for keeping individual systems in validation
• Computer system users
• QA / QC managers, executives, and personnel
• IT / IS managers and personnel
• Validation specialists
• Software quality reviewers
• Consultants

ABOUT THE INSTRUCTOR:

Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation, and maintenance of computerized systems used in FDA-compliant applications. His most popular book is Risk Based Software Validation – Ten Easy Steps, which provides fill-in-the-blank templates for completing a COTS software validation project.

David has completed more than 300 mission-critical laboratory, clinical, and manufacturing software implementation projects. Services are available to guide companies to create and maintain the systems and procedures required to pass regulatory audits: product features, vendor audits, software validation, SOPs, training, gap analysis, remediation plans, and project management.

Refund policy:

Attendees may cancel up to two working days prior to the course start date and the refund will be processed within two working days.

We will process/provide a refund if the webinar is canceled. Refunds will not be given to participants who do not show up for the webinar. On-demand recordings can be requested in exchange. The webinar may be canceled due to a lack of enrolment or unavoidable factors. Attendees will be notified 24 hours in advance if a cancellation occurs. Substitutions can happen at any time.

If you have any concerns about the content of the webinar and are not satisfied please contact us at care@thecomplyguide.com