- Certificate of completion - Free
- Tutor is available to students
Project Management is defined as the planning and organization of an organization's resources in order to move a specific task, event or duty toward completion.
However, Validation of Computerized Systems has a very specific set of tasks that are often mismanaged, resulting in missed deadlines, increased costs, and regulatory risk, and missed times to market for a company's product.
The practice of Project Management within the highly regulated world of the FDA inspected industries provides unique challenges and opportunities. It is considered good project management practice to integrate Data Integrity, Computer Systems Validation, 21 CFR 11 and Annex 11 with relevant project management activities to ensure that compliance risk is managed effectively and proactively.
This presentation provides good practice approaches which promote the successful integration of Computer Systems Validation requirements.
In this Session speaker explain the Basics of Project Management and Computer Systems Validation, the basic tenets of 21 CFR 11 compliance for Computer Systems Validation and will show how to marry the two, to deliver on time and on budget.
Digital certificate - Included
Why you should Attend:
Per the CDRH, 20% of product recalls in the medical device industry are due to faulty software!!! Yet, these human, financial and reputation capital expensive issues, can be averted with computerized systems validation that fosters data integrity, 21 CFR 11 & Annex 11 compliance.
The Project Manager for a Validated Computerized System has to deliver on time and on budget, but with the added risk of having to meet regulatory compliance, often causing project overruns, regulatory findings and missed times to market.
The Class will:
Learning Objectives: PART 1: Background, Basics, Context: 60 Minutes
PART 2: Project Management for Computer Systems Validation Detail 1 - 60 Minutes
PART 3: Project Management for Computer Systems Validation Detail 2 - 60 Minutes
Currently there are no Q&As for this course. Be the first to ask a question.
Currently there are no reviews for this course. Be the first to leave a review.
This course is advertised on reed.co.uk by the Course Provider, whose terms and conditions apply. Purchases are made directly from the Course Provider, and as such, content and materials are supplied by the Course Provider directly. Reed is acting as agent and not reseller in relation to this course. Reed's only responsibility is to facilitate your payment for the course. It is your responsibility to review and agree to the Course Provider's terms and conditions and satisfy yourself as to the suitability of the course you intend to purchase. Reed will not have any responsibility for the content of the course and/or associated materials.
Interest free credit agreements provided by Zopa Bank Limited trading as DivideBuy are not regulated by the Financial Conduct Authority and do not fall under the jurisdiction of the Financial Ombudsman Service. Zopa Bank Limited trading as DivideBuy is authorised by the Prudential Regulation Authority and regulated by the Financial Conduct Authority and the Prudential Regulation Authority, and entered on the Financial Services Register (800542). Zopa Bank Limited (10627575) is incorporated in England & Wales and has its registered office at: 1st Floor, Cottons Centre, Tooley Street, London, SE1 2QG. VAT Number 281765280. DivideBuy's trading address is First Floor, Brunswick Court, Brunswick Street, Newcastle-under-Lyme, ST5 1HH. © Zopa Bank Limited 2024. All rights reserved.