- Banking & Financial Services
- BANKING & FINANCIAL SERVICES
- Banks and Credit Unions
- Financial Services and Trading
- Insurance
- Accounting and Taxation
- Life Sciences
- Hitech, Aero & Manufacturing
- HITECH, AERO & MANUFACTURING
- Quality & Safety
- Standards and Methodology
- Energy & Utilities
- ENERGY & UTILITIES
- IT Security
- Reliability (NERC / FERC)
- Quality and Safety
- Risk Management
- CPG & Retail
- CPG & RETAIL
- Retail Audit
- Quality & Safety
- Social Compliance
- Healthcare
- Food & Dietary Supplements
- Cross Industry Functions
This highly interactive two-day course uses real life examples and explores proven techniques for reducing costs, usually by two-thirds, associated with implementing, and maintaining computer systems in regulated environments.
- It details the requirements for Part 11 and Annex 11: SOPs, software product features, infrastructure qualification, and validation.
- 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.
- Understand the specific requirements associated with local and SaaS/cloud hosting solutions.
- It details the requirements for HIPAA Protect Health Information (PHI)
- 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.
- The instructor reviews recent FDA inspection trends and discusses how to streamline document authoring, revision, review, and approval.
- Participants will learn how to write a Data Privacy Statement to comply with the EU General Data Protection Regulation (GDPR).
- This course benefits anyone that uses computer systems to perform their job functions and is ideal for 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.
Learning Objectives:
- Reduce costs, usually by two-thirds, for compliance with electronic records
- Learn how to use electronic records and electronic signatures to maximize productivity
- Understand what is expected in Part 11 and Annex 11 inspections so you are prepared
- Avoid 483 and Warning Letters
- Understand the responsibilities and specific duties of your staff including IT and QA
- Understand your responsibilities and liabilities when using SaaS/cloud
- Learn how HIPAA expands Part 11 compliance
- Learn how to perform risk-based Computer System Validation using fill-in-the-blank templates
- How to select resources and manage validation projects
- "Right size" change control methods that allows quick and safe system evolution
- Minimize validation documentation to reduce costs without increasing regulatory or business risk
- Learn how to reduce testing time and write test cases that trace to elements of risk management
- Learn how to comply with the requirements for data privacy
- Learn how to buy COTS software and qualify vendors
- Protect intellectual property and keep electronic records safe
Interview with
David Nettleton, FDA Compliance Specialist
Who will Benefit:
- GMP, GCP, GLP, regulatory professionals
- QA/QC
- IT
- Auditors
- Managers and directors
- Software vendors, hosting providers
- 08.00 AM - 08.30 AM: Registration
- 08.30 AM: Session Start
- Introduction to the FDA (1.5 hrs)
- How the regulations help your company to be successful
- Which data and systems are subject to Part 11.
- 21 CFR Part 11 - Compliance for Electronic Records and Signatures (4 hrs)
- What Part 11 means to you, not just what it says in the regulations
- Avoid 483 and Warning Letters
- Explore the four primary areas of Part 11 compliance: SOPs, software product features, infrastructure qualification, 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
- HIPAA Compliance for Electronic Records (30 Min)
- How Part 11 and HIPAA interrelate
- What are the additional requirements for patient data
- The Five Keys to COTS Computer System Validation (30 Min)
- The Who, What, Where, When, and Why of CSV
- The Validation Team (30 Min)
- How to select team members
- How to facilitate a validation project
- Ten-Step Process for COTS Risk-Based Computer System Validation (1 hr)
- 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).
- How to Write Requirements and Specifications (30 Min)
- Workshop for writing requirements and then expanding them for specifications
- How to Conduct a Hazard Analysis/Risk Assessment-Exercise (30 Min)
- Step-by-step instructions for performing and documenting a risk assessment, and how to use the results to reduce validation documentation.
- Software Testing (1 hr)
- Reduce testing by writing test cases that trace to elements of risk management.
- How to write efficient test cases
- How to write a Data Privacy Statement (30 Min)
- How to meet the requirements of the EU GDPR
- Purchasing COTS Software (30 Min)
- How to purchase COTS software and evaluate software vendors
- Cost Reduction Without Increasing Regulatory or Business Risk (1 hr)
- How to save money
- How to increase quality
- How to increase compliance with less documentation
David Nettleton
FDA Compliance Specialist, Computer System Validation
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 230 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.
Interview with
David Nettleton, FDA Compliance Specialist
Location 1:
Los Angeles, CA
(Venue to be announced shortly)
February 13-14, 2019
Location 2:
San Diego, CA
(Venue to be announced shortly)
March 27-28, 2019
Testimonials
See What People Say About Us
System Admin, IT
Business System Analyst
Director of Quality
Test Engineer
Software and Training Support Specialist
Director, Validation
Business System Analyst
Manager, IT
VP Global CRM & Business Solutions
Business System Analyst, Documentation
Test Engineer
Sr. Manager, IT
Director Technical Services
Director, Agile Systems and Processes
Business Systems Manager
Project Engineer
Software Quality Assurance
Global Quality Operations Analyst
Software Vendor, Vancouver, BC
Technical Writer
Contract Research Organization, Los Angeles, CA
Pharmaceutical company, San Francisco, CA
Lisa Wyeth
Lead Auditor
Sr. Validation Engineer
Associate Director
QA/RA Manager
Sr. Validation Engineer
Information Technology Specialist
IT Director
Project Manager
The registration was an easy process. I forwarded the information to our Human Resources and they were able to handle it from the beginning.
GCP Manager
Assistant Manager of Technical Development
Software Quality Manager
Engineering Electrical Controls Manager
Director - Global IT Governance
Sr. QA Engineer
Associate Director, Quality Operations
Lead Auditor/Sr. Laboratory Compliance Specialist
He explained very well the concepts and gave good examples however is when we do things by our selves that we better understand and make the concepts "ours" The place and lightening was fine, there was no noise interrupting.
Software Validation Engineer
Research & Development Associate
Director of Regulatory Affairs,
Nickell Physician & Pharmacy Services
We are pleased to offer several exhibitor, sponsorship and media partnership options designed to maximize your company's exposure and networking opportunities before, during and after the event.
Benefits of becoming a Sponsor/Exhibitor/Media Partner:
- Logo on website, marketing email, branding materials & the registration booth
- Exhibit Space
- Free event pass
- Speaking opportunity
- Social media campaign
For more details and other sponsorship options at this event, please contact Event Manager: customercare@complianceonline.com or call: +1-650-238-9656
Media Partner:
Local Attractions of Los Angeles, CA
Griffith Observatory
Griffith Observatory is an icon of Los Angeles, a national leader in public astronomy, a beloved civic gathering place, and one of southern California's most popular attractions. The Observatory is located on the southern slope of Mount Hollywood in Griffith Park, just above the Los Feliz neighborhood. It is 1,134 feet above sea level and is visible from many parts of the Los Angeles basin.
Universal Studios Hollywood
Universal Studios Hollywood is a movie studio and theme park in the Los Angeles County, California, United States. It is one of the oldest and most famous Hollywood movie studios still in use. Its official marketing headline is "The Entertainment Capital of LA", though during the summer it is often advertised as "The Coolest Place in LA. It is the first of many full-fledged Universal Studios Theme Parks located across the world.
Los Angeles County Museum of Art
The Los Angeles County Museum of Art (LACMA) is the largest art museum in the western United States. It attracts nearly a million visitors annually. Its holdings of more than 100,000 works span the history of art from ancient times to the present. In addition to art exhibits, the museum features film and concert series.
Beverly Center
Beverly Center Shopping Mall is a large indoor shopping center located near Beverly Hills. Beverly Center is Southern California's premier fashion destination with over 100 distinctive specialty boutiques reflecting the diverse styles and tastes of Los Angeles. The Center is anchored by Bloomingdale’s, Macy’s and the upscale dining destination, The Capital Grille.
Venice Beach
Venice Beach is a seaside neighborhood of Los Angeles. Named for its series of canals, Venice is known as a haven for creative types. It is famous for its bohemian boardwalk and for the eclectic Abbot Kinney Blvd. Venice Beach include the beach, the promenade that runs parallel to the beach (“Ocean Front Walk” or just “the boardwalk”), Muscle Beach, the handball courts, the paddle tennis courts, Skate Dancing plaza, the numerous beach volleyball courts, the bike trail and the businesses and residences that have their addresses on Ocean Front Walk.
Local Attractions of San Diego, CA
San Diego Cabrillo National Monument
Board a luxurious Think Escape party bus or limo and be whisked away to San Francisco's hottest nightclubs where VIP treatment brings all party bus guests to the front of the line. Board a luxurious Think Escape party bus or limo and be whisked away to San Francisco's hottest nightclubs where VIP treatment brings all party bus guests to the front of the line. Board a luxurious Think Escape party bus or limo and be whisked away to San Francisco's hottest nightclubs where VIP treatment brings all party bus guests to the front of the line.
Sea Creatures at Birch Aquarium
Birch Aquarium is north of San Diego in La Jolla. It's not as big as some of the other aquariums in California or as flashy as the big sea-themed park down the road, but instead just right, filled with interesting exhibits and home to leafy sea dragons like the one above, creatures so improbably they look more like something from a children's book than from the ocean.
Legoland
Legoland theme park takes its inspiration from Lego toys, those cute little bricks that snap together to build all kinds of fun things. It's one of several Legolands worldwide.
San Diego Zoo Safari Park
The San Diego Zoo's sister park offers a different kind of animal experience. Its name (Safari Park) is the clue and it indeed offers a more safari-like experience. Lots of large animals live in the same big, open areas here - predators kept away from prey, but otherwise much as they would in their natural habitat.
Coronado Island
Coronado isn't really an island but a peninsula - a fact that doesn't get in the way of the name most people use for it. Whatever you call it, it's on a slender strip of land between the San Diego Bay and the Pacific Ocean, barely a few blocks wide. What it lacks in size it makes up for in fun, with a beach that's been named among the best in the country, a classic hotel and a compact, lively little downtown. Coronado's laid-back temperament makes a nice break from the busier parts of San Diego across the water.
Balboa Park
Originally built for temporary use during the 1915-16 Panama-California Exposition in San Diego, Balboa Park boasts buildings beautiful enough to be considered attractions in themselves, especially if you're a photographer. They're surrounded by trees, lawns and fountains, but that's only the beginning.
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