- 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
Data integrity has been a focus for pharmaceutical regulatory inspections for a number of years and look set to remain of concern to regulators and manufacturers for many years to come. Many inspection reports from regulatory agencies around the world cite data integrity as a cause of observations and enforcement action, and actions taken by regulators to restrict the commercial activities of manufacturers on the grounds of data integrity violations have obvious serious consequences for the company concerned.
This 2-day course explains the background to the data integrity regulations and sets out the expectations of pharmaceutical regulators. All the current data integrity guidances emphasise a risk-based approach to compliance, and the course explains how to evaluate and control data integrity risks. A key resource in relation to electronic records is GAMP 5, which deals with controlling risk and managing computerised systems over their life cycle. The practices recommended by GAMP 5 will be dealt with in detail, and practical advice on the appropriate use of Excel spreadsheets given. Data integrity should not be thought of as an exclusively analytical problem, and examples of data integrity violations in production will highlight the risks during manufacturing.
The course includes practical exercises which are designed to reinforce the taught component. These include data integrity risk assessments, categories of computerised data system and conducting a data integrity audit.
Learning Objectives:
Attendees will:
- Understand what data integrity is and why it is so important for patient safety
- Recognise that there are many causes of data integrity breaches
- Know the current regulatory expectations
- Appreciate the difference between static and dynamic records, and be able to apply acceptable strategies for the retention of both types of record
- Be able to categorise and validate GxP computerised systems according to GAMP 5
- Understand the importance of training and quality culture in avoiding regulatory enforcement action
- Learn how to respond to data integrity observations in inspection reports
- Learn how to prevent, detect and remedy data integrity problems
Who will Benefit:
- QA managers and personnel
- Laboratory managers and supervisors
- Production managers and supervisors
- Analysts
- IT/IS managers and system administrators
- Software developers
- Regulatory affairs
- Training departments
- Documentation departments
- Consultants
- Auditors
Companies and departments:
- Pharmaceutical development and Quality control laboratories
- API manufacturers
- Medical device companies
- Contract laboratories
- Clinical research organisations
- Suppliers and service providers of instruments and computer systems
- 08.30 AM - 09.00 AM: Registration
- 09.00 AM: Session Start
- Day 1 – Lectures and Workshop Exercises
- Module 1: Historical background and data integrity definitions
- Data integrity and patient safety/product efficacy
- The evolution of GxP regulations – driven by both criminal activity and honest mistakes
- The US FDA’s debarment policy
- Evolution of data integrity guidances
- Introduction to GAMP 5
- Early data integrity cases
- Module 2: Regulatory expectations
- ALCOA and ALCOA+
- Static and dynamic records
- Essential elements of data governance
- Non-conformance trends
- Data integrity controls
- Data integrity risks in sample analysis and production
- Investigating data integrity problems
- Metadata, audit trails and audit trail review
- Exercise: deliberate falsification
- Module 3: Data integrity risk assessment
- Quality risk management: ICH Q9
- Risk management process
- Approaching a data integrity risk assessment
- Controlling risk in computerised systems
- Configuration and life cycle management
- Operating system and application software considerations
- Module 4: Computerised systems
- Audit trails, access controls and user permissions
- Exercise: reviewing records for data integrity violations
- Excel spreadsheets
- Introduction to computerised data system validation
- Module 5: Day 1 conclusions
- Extracts from regulatory enforcement letters
- Addressing data integrity problems
- Day 2 - Lectures and Workshop Exercises
- Module 6: Managing computerised data systems
- Guidance
- 21 CFR Part 11
- EU Annex 11
- GAMP 5
- Life cycle management and risk assessment
- Supplier assessment
- Guidance
- Module 7: Computerised system validation
- Validation planning
- Policy
- Plans
- Documentation
- System description
- Introduction to software testing
- Validation planning
- Module 8: Conducting a data integrity audit
- Planning the audit
- Conducting the audit
- Policies, procedures, practices
- Training
- Quality culture
- Evaluating quality risk
- Mitigating data integrity risks
- Module 9: Managing client audits and regulatory inspections
- The importance of data integrity risk assessments/action plans
- The audit/inspection process
- Client audits
- Confidentiality
- Result checking and reporting
- Regulatory inspections
- Behaviour during inspection
- Responding to non-conformance observations
Mark Powell
Director, Mark Powell Scientific Limited
Dr Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as an analytical chemist. Mark was Honorary Treasurer of the RSC’s Analytical Division and led a working group on continuing professional development until July 2016, when his term of office ended. Between 2003 and 2013, he was the Analytical Development Manager, and later Scientific Manager, of a UK-based contract research organization which specialized in early-stage oral drug development. During this time, he was responsible for method validation, verification and transfer activities, as well as the qualification of laboratory instruments and computerized data systems. In 2013, he set up Mark Powell Scientific Limited, which provides training and consultancy services to pharmaceutical companies. Mark has since enjoyed working with companies of all sizes around the world on a variety of training and consultancy assignments, and has recently co-authored a White Paper on Pharmaceutical Data Integrity for the laboratory supply company VWR.
Location 1:
San Diego, CA
(Venue to be announced shortly)
March 26-27, 2020
Location 3:
Copenhagen, Denmark
(Venue to be announced shortly)
June 18-19, 2020
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: +1-650-332-0381
Media Partner:
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.
Local Attractions of Copenhagen, Denmark
Tivoli Gardens
Tivoli Gardens is a famous amusement park and pleasure garden in Copenhagen, Denmark. The park opened on 15 August 1843. With 4.733 million visitors in 2015, Tivoli is the second-most popular seasonal theme park in the world, the most-visited theme park in Scandinavia and the fourth most-visited in Europe, only behind Disneyland Paris, Europa-Park Rust and the Efteling. The park is best known for its wooden roller coaster, Rutschebanen, built in 1914. It is one of world's oldest wooden roller coasters that is still operating today. Another roller coaster, Dæmonen (The Demon), features an Immelmann loop, a loop, and a zero-G roll all during the ride time of just one minute and forty six seconds. The world's second tallest carousel, The Star Flyer, opened in Tivoli in 2006.
National Museum of Denmark
The National Museum of Denmark (Nationalmuseet) in Copenhagen is Denmark’s largest museum of cultural history, comprising the histories of Danish and foreign cultures alike. The museum's main building is located a short distance from Strøget at the center of Copenhagen. It contains exhibits from around the world, from Greenland to South America. Additionally, the museum sponsors SILA - The Greenland Research Centre at the National Museum of Denmark to further archaeological and anthropological research in Greenland. The museum covers 14,000 years of Danish history, from the reindeer-hunters of the Ice Age, Vikings, and works of religious art from the Middle Ages. The National Museum keeps Denmark’s largest and most varied collection of objects from the ancient cultures of Greece and Italy, the Near East and Egypt
Amalienborg
Amalienborg is the home of the Danish royal family. It consists of four identical classical palace façades with rococo interiors around an octagonal courtyard. In the centre of the square is a monumental equestrian statue of Amalienborg's founder, King Frederick V. Amalienborg was originally built for four noble families; however, when Christiansborg Palace burned on 26 February 1794, the royal family bought the palaces and moved in. Over the years various kings and their families have resided in the four different palaces.
Strøget
Strøget is a pedestrian, car free shopping area in Copenhagen. This popular tourist attraction in the centre of town is one of the longest pedestrian shopping streets in Europe at 1.1 km. Located at the centre of the old city of Copenhagen, it has long been one of the most high-profile streets in the city. The pedestrianisation of Strøget in 1962 marked the beginning a major change in the approach of Copenhagen to urban life; following the success of the initiative the city moved to place a much greater emphasis on pedestrian and bicycle access to the city at the expense of cars. Many of the city's most famous and expensive stores, such as Illums Bolighus, Magasin du Nord, and the Royal Copenhagen Porcelain Factory are located along the strip, as well as some of the most famous and expensive luxury brand chain stores in the world. It also features a multitude of souvenir shops and fast food outlets.
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