This interactive two-day course will explore proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. 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.
Many companies outsource IT resources and are involved in 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 to avoid FDA form 483s and Warning Letters.
This course is intended for these regulated companies, software vendors, and SaaS/cloud providers. The seminar instructor will:
- Address the latest computer system industry standards for data security,data transfer, audit trails, electronic records and signatures, software validation, and computer system validation.
- Help participants understand the specific requirements associated with local and SaaS/cloud hosting solutions.
- Illustrate the importance of validating the quality process and every computerized system used in laboratory, clinical, and manufacturing settings.
- Demonstrate how to decrease software implementation times and lower costs using a 10-step risk-based approach to computer system validation.
- Review recent FDA inspection trends and discuss how to streamline document authoring, revision, review, and approval.
Learning Objectives:
- Understand what is expected in Part 11 and Annex 11 inspections
- Avoid 483s 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
Interview with
David Nettleton, FDA Compliance Specialist
Who will Benefit:
This course will benefit all who use 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.
- Regulatory Affairs
- QA/ QC
- IT/IS
- Software Managers
- Project Managers
- Software vendors and suppliers
- 08.00 AM - 08.30 AM: Registration
- 08.30 AM: Session Start
- Introduction to the FDA (1 hr)
- 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 hr)
- What Part 11 means to you, not just what it says in the regulation.
- 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.
- 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
- System Change Control (30 Min)
- How to manage a validated system with minimal documentation
- 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
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The registration was an easy process. I forwarded the information to our Human Resources and they were able to handle it from the beginning.
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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.
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Local Attractions of Stockholm, Sweden
Gamla Stan
Gamla stan (The Old Town) until 1980 officially Staden mellan broarna (The Town between the Bridges), is the old town of Stockholm, Sweden. Gamla stan consists primarily of the island Stadsholmen. Officially, Gamla stan includes the surrounding islets Riddarholmen, Helgeandsholmen, and Strömsborg. The town dates back to the 13th century, and consists of medieval alleyways, cobbled streets, and archaic architecture. North German architecture has had a strong influence in the Old Town's construction. As well as being home to the Stockholm Cathedral, the Nobel Museum, and the Riddarholm church, Gamla stan also boasts Kungliga slottet, Sweden's baroque Royal Palace, built in the 18th century after the previous palace Tre Kronor burned down. The restaurant Den gyldene freden is located on Österlånggatan. It has been in business since 1722 and according to the Guinness Book of Records is the oldest existing restaurant with an unaltered interior.
Vasa Museum
The Vasa Museum is a maritime museum in Stockholm. Located on the island of Djurgården, the museum displays the only almost fully intact 17th century ship that has ever been salvaged, the 64-gun warship Vasa that sank on her maiden voyage in 1628. The Vasa Museum opened in 1990 and, according to the official web site, is the most visited museum in Scandinavia. Together with other museums such as Stockholm Maritime Museum, the museum belongs to the Swedish National Maritime Museums (SNMM). The main hall contains the ship itself and various exhibits related to the archaeological findings of the ships and early 17th century Sweden. The museum also features four other museum ships moored in the harbour outside: the ice breaker Sankt Erik (launched 1915), the lightvessel Finngrundet (1903), the torpedo boat Spica (1966) and the rescue boat Bernhard Ingelsson (1944).
Skansen
Skansen (the Sconce) is the first open-air museum and zoo in Sweden and is located on the island Djurgarden in Stockholm. It was founded in 1891 by Artur Hazelius (1833–1901) to show the way of life in the different parts of Sweden before the industrial era. Skansen attracts more than 1.3 million visitors each year. The many exhibits over the 75 acre site include a full replica of an average 19th-century town, in which craftsmen in traditional dress such as tanners, shoemakers, silversmiths, bakers and glass-blowers demonstrate their skills in period surroundings. There is even a small patch growing tobacco used for the making of cigarettes. There is also an open-air zoo containing a wide range of Scandinavian animals including the bison, brown bear, moose, grey seal, lynx, otter, red fox, reindeer, wolf, and wolverine (as well as some non-Scandinavian animals because of their popularity). There are also farmsteads where rare breeds of farm animals can be seen.
Drottningholm Palace
The Drottningholm Palace is the private residence of the Swedish royal family, located in Drottningholm. Built on the island Lovön, it is one of Sweden's Royal Palaces. It was originally built in the late 16th century. It served as a regular summer residence of the Swedish royal court for most of the 18th century. Apart from being the private residence of the Swedish royal family, the palace is a popular tourist attraction. The palace and its grounds have seen many renovations, changes and additions over the past 400 years. The largest renovation, in which electricity, heating, sewage, water lines were either installed or updated and the castle roof replaced, took place between 1907 and 1913. The gardens and park areas surrounding the castle and its buildings are one of the main attractions for the tourists that visit the palace each year. The gardens have been established in stages since the castle was built, resulting in different styles of parks and gardens.
Junibacken
Junibacken is a children’s museum, situated on the island of Djurgården in the centre of Stockholm. The museum is Stockholm’s 5th most-visited tourist attraction. The museum is devoted to Swedish children’s literature, but especially Astrid Lindgren. Outside the building is a bronze statue of Lindgren. The art direction and images for the interior design were made by Swedish artist Marit Törnqvist, who had previously made illustrations for more recent versions of Lindgren's books. The museum contains the largest children’s bookstore in Sweden. The lockers in the entrance hall are unusual in that each is in the form of a giant book-spine, featuring world classics such as Treasure Island and The Jungle Book. Other main attractions include a Storybook Square, a mock public square where each house is devoted to a separate Swedish children’s author, from the earliest writers such as Elsa Beskow to recent writers such as Sven Nordqvist.
