21 CFR Part 11 compliance for software validation and SaaS/Cloud Seminar 2018

Course

In Singapore (Singapore)

£ 1,355.27 VAT inc.

*Indicative price

Original amount in USD:

$ 1,695

Description

  • Type

    Seminar

  • Location

    Singapore (Singapore)

  • Class hours

    9h

  • Duration

    2 Days

This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments.
Many companies are outsourcing IT resources and getting involved with Software as a Service (SaaS) and cloud computing. These vendors are not regulated and therefore regulated companies must ensure compliance for both infrastructure qualification and computer system validation. It is the regulated company that wants to avoid FDA form 483s and Warning Letters. The seminar is intended for regulated companies, software vendors, and SaaS/Cloud providers.
The instructor addresses the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and computer system validation.
Today, the FDA performs both GxP and Part 11 inspections, and the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements. Companies must update their systems and processes to maintain compliance.
This seminar will help you understand the specific requirements associated with local and SaaS/cloud hosting solutions.
Nearly every computerized system used in laboratory, clinical, manufacturing settings and in the quality process has to be validated.
Participants learn how to decrease software implementation times and lower costs using a 10-step risk-based approach to computer system validation.
Finally, the instructor reviews recent FDA inspection trends and discusses how to streamline document authoring, revision, review, and approval.
This course benefits anyone that uses computer systems to perform their job functions and is ideal for regulatory, clinical, and IT professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors. It is essential for software vendors, auditors, and quality staff involved in GxP applications.

Facilities

Location

Start date

Singapore (Singapore)
See map
333 Orchard Road, 238867

Start date

On request

About this course

Understand what is expected in Part 11 and Annex 11 inspections
Avoid 483 and Warning Letters
Learn how to buy COTS software and qualify vendors.
Implement a computer system using risk-based validation to gain maximum productivity and reduce cost by as much as two thirds
Requirements for local, SaaS, and cloud hosting
How to select resources and manage validation projects
"Right size" change control methods that allows quick and safe system evolution
Minimize the validation documentation to reduce costs without increasing regulatory or business risk
Write test cases that trace to elements of risk management
Protect intellectual property and keep electronic records safe

QA, IT, management
all GxP system users

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Reviews

Subjects

  • Risk
  • Compliance
  • Audit
  • Computing
  • Testing
  • Approach
  • Quality Training
  • IT risk
  • Industry
  • Systems
  • Quality

Teachers and trainers (1)

David Nettleton  David Nettleton

David Nettleton David Nettleton

FDA Compliance Specialist,

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. He has completed more than 260 mission critical laboratory, clinical, and manufacturing software implementation projects. His most popular book is Risk Based Software Validation - Ten easy Steps, which provides fill-in-the-blank templates for completing a COTS

Course programme

Day 1 Schedule Lecture 1:

Introduction to the FDA

  • How the regulations help your company to be successful
  • Which data and systems are subject to Part 11
Lecture 2:

21 CFR Part 11/Annex 11 - Compliance for Electronic Records and Signatures

  • What Part 11 means to you, not just what it says in the regulations
  • Avoid 483 and Warning Letters
  • Explore the three primary areas of Part 11 compliance: SOPs, software product features, and validation documentation
  • How SaaS/cloud computing changes qualification and validation
  • Ensure data integrity, security, and protect intellectual property
  • Understand the current computer system industry standards for security, data transfer, and audit trails
  • Electronic signatures, digital pens, and biometric signatures
  • SOPs required for the IT infrastructure
  • Product features to look for when purchasing COTS software
  • Reduce validation resources by using easy to understand fill-in-the-blank validation documents

21 CFR Part 11 compliance for software validation and SaaS/Cloud Seminar 2018

£ 1,355.27 VAT inc.

*Indicative price

Original amount in USD:

$ 1,695