Risk-based Computer System Validation; Reduce Costs and Avoid 483
July 10, 2020 | 11 AM EST
OVERVIEWThis training session describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud hosted applications. What the regulations mean is described for all four primary compliance areas: SOPs, software features, infrastructure qualification, and validation. It gets you on the right track for using electronic records and signatures to greatly increase productivity and ensure compliance.
WHAT YOU'LL LEARN
- Which data and systems are subject to Part 11 and Annex 11
- What the regulations mean, not just what they say
- Avoid 483 and Warning Letters
- Requirements for local, SaaS, and cloud hosting
- Understand the current industry standard software features for security, data transfer, audit trails, and electronic signatures
- How to use electronic signatures, ensure data integrity, and protect intellectual property
- 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
WHO SHOULD ATTEND
- GMP, GCP, GLP, regulatory professionals
- Managers and directors
- Software vendors, hosting providers
MEET THE PRESENTERS
Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, EU General Data Protection Regulation (GDPR), 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 290 mission critical laboratory, clinical, and manufacturing software implementation projects. His latest book is Software as a Service (SaaS) Risk-Based Validation with Time-Saving Templates , which provides fill-in-the-blank templates for completing a COTS software validation project.
FDA Compliance Specialist
EARN CEUsParticipants are eligible to receive CEUs upon attendance and successful completion of a web-based assessment within 30 days after the webinar. CEUs are not granted after the 30-day assessment deadline.
SCDM is authorized by IACET to offer 0.2 CEUs for this program.
|Group (max. 10 ppl.)||$960||$1,140|
Group Registration Policy: Any group registration allows up to 10 people to attend the webinar and to complete the webinar assessment. Credits will be granted on an individual basis upon successful completion of the assessment by the registered participants.
Refund Policy: Participants will receive a full refund if notice is provided in writing via post or email one week prior to the webinar date. If cancellation occurs within the week prior the webinar, participants will be allowed to apply 50% of the webinar fee to the next offering of the same webinar. No refunds will be offered after that time.
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