21 CFR Part 11 Compliance for Software Validation and SaaS/Cloud

This event qualifies for 12 RAC

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, the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements and 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.

Course Objectives:

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

Who will benefit:

QA, IT, management
all GxP system users

Speaker and Presenter Information

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 software validation project.

Services are available to guide companies to create and maintain the systems and procedures required to pass regulatory inspections: product features, vendor audits, software validation, SOPs, training, gap analysis, remediation plans, and project management.

Projects involve: medical devices, blood bank, clinical trial, corrective action, document control, electronic data capture, Excel spreadsheets, laboratory instruments, laboratory information management (LIMS), manufacturing, enterprise resource planning, toxicology systems, and VMWare.