How to be efficient and compliant with 21 CFR Part 11

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.

Agenda:

Day 1 Schedule

(8am to 5pm; 0.5 registration, 1.0 lunch, 0.5 (2-15min) breaks, 7.0 class = 9.0)

8:00am to 8:30am registration

8:30am class starts

Lecture 1: Introduction to the FDA (1:30) {1:30}

• 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 (4:00) {5:30}

• 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

Lecture 3: HIPAA Compliance for Electronic Records (0:30) {6:00}

• How Part 11 and HIPAA interrelate
• What are the additional requirements for patient data

Lecture 4: The Five Keys to COTS Computer System Validation (0:30) {6:30}

• The Who, What, Where, When, and Why of CSV

Lecture 5: The Validation Team (0:30) {7:00}

• How to select team members
• How to facilitate a validation project

Day 2 Schedule

(9am to 3:30pm; 1.0 lunch, 0.5 (2-15min) breaks, 5.00 class = 6.5)

Lecture 6: Ten-Step Process for COTS Risk-Based Computer System Validation (1:00) {1:00}

• Learn which documents the FDA expects to audit.
• How to use the risk-based validation approach to lower costs.
• How to link requirements, specifications, risk management, and testing.
• Document a computer system validation project using easy to understand fill-in-the-blank templates.
• Based on: "Risk-Based Software Validation - Ten Easy Steps" (Davis Horwood International and PDA - www.pda.org, 2006).

Lecture 7: How to Write Requirements and Specifications (0:30) {1:30}

• Workshop for writing requirements and then expanding them for specifications

Lecture 8: How to Conduct a Hazard Analysis/Risk Assessment-Exercise (0:30) {2:00}

• Step-by-step instructions for performing and documenting a risk assessment, and how to use the results to reduce validation documentation.

Lecture 9: Software Testing (1:00) {3:00}

• Reduce testing by writing test cases that trace to elements of risk management.
• How to write efficient test cases

Lecture 10: System Change Control (0:30) {3:30}

• How to manage a validated system with minimal documentation

Lecture 11: Purchasing COTS Software (0:30) {4:00}

• How to purchase COTS software and evaluate software vendors.

Lecture 12: Cost Reduction Without Increasing Regulatory or Business Risk (1:00) {5:00}

• How to save money
• How to increase quality
• How to increase compliance with less documentation

Speaker:

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 270 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.

Location:  Boston, MA Date: September 11th & 12th, 2018 and Time: 8:00 AM to 5:00 PM

Venue:  Four Points by Sheraton Boston Logan Airport Revere, MA 407 Squire Rd, Revere, Massachusetts 02151, United States

Price:

Register now and save $200. (Early Bird)

Until August 10, Early Bird Price: $1,295.00

From August 11 to September 09, Regular Price: $1,495.00

Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*

Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)*

Sponsorship Program benefits for seminar

For More Information- https://www.globalcompliancepanel.com/control/sponsorship

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john.robinson@globalcompliancepanel.com

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