ComplianceOnline

Course "A risk based approach to GxP Compliant Laboratory Computerized Systems" has been pre-approved by RAPS as eligible for up to 10 credits towards a participant's RAC recertification upon full completion.

Laboratory Computerized Systems and data management operations are increasing in variety, sophistication and complexity in the GxP environment. Widespread reliance on these systems, along with their potential impact on data integrity, and the trend towards cost efficiency within companies, means that companies need achieve GxP compliance of laboratory computerized systems– within a reasonable budget and timeline.

The wide diversity of these systems, coupled with their capability for networking, makes it impractical and inefficient to have single approach to achieve GxP compliance for all systems. For example, a High Performance Liquid Chromatography (HPLC) with a Photo Diode Array (PDA) detector is much more complex than a pH meter, and will require a correspondingly more detailed and complex implementation, control and maintenance approach.

Poor management of laboratory computerized system acquisition, implementation and operation may result in:

  • Failing to meet process and user requirements
  • Unacceptable cost or time overruns
  • Risk of non-compliance
  • Data Integrity issues
Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

On the other hand, there are major business benefits to both regulated organizations and suppliers, in delivering systems that defined and specified and are easier to support and maintain. Benefits include:

  • Reduction of cost and time taken to achieve and maintain compliance
  • Early defect identification and resolution leading to reduced impact on cost and schedule
  • Cost effective operation and maintenance
  • Effective change management and process for continual improvement
  • Enabling of innovation and adoption of new technology
  • Providing frameworks for user / supplier co-operation
  • Assisting suppliers to produce required documentation
  • Promotion of common, consistent, system life cycle, language and terminology
  • Providing practical guidelines and examples
  • Promoting pragmatic interpretation of regulations

Learning Objectives:

This hands-on seminar provides a practical, risk based approach to laboratory computerized system specification, verification, and implementation by:

  • Examining the system life cycle and its applicability for most laboratory computerized systems
  • Identifying characteristics that distinguish various types of laboratory computerized systems
  • Developing a rationale for scaling activities and effort based upon risk, complexity, and novelty
  • Defining a strategy for supplier assessments, and the effective leveraging of supplier knowledge, experience, and documentation
  • Applying the GAMP® 5 Quality Risk Management (QRM) approach
  • Defining necessary operational and maintenance activities
  • Recommending an approach to system retirement
  • Leveraging deliverables and activities for very similar or identical systems

Who will Benefit:

  • Lab Director
  • Lab Scientists
  • Computer Validation Professional responsible for defining and managing laboratory computerized systems in regulated life science industries
  • Information Technology (IT) personnel
  • IT support services
  • Management and Laboratory System users
  • Software Developers
  • Suppliers of Computerized systems including suppliers or:
    • Software
    • Hardware
    • Analytical instrumentation
    • System integration services
    • IT support services
  • Regulators

Industries:

  • Pharmaceuticals
  • Biotech
  • Medical Device
  • Radiological Health
  • Blood Products
  • Companion Animals
  • Food
  • Cosmetics
  • Tobacco
  • Academia
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Day 01(8:30 AM - 4:30 PM)
  • 08.30 AM - 09.00 AM: Registration
  • 09.00 AM: Session Start
  • Lecture 1: Introduction and Background
    • Introductions / Participants’ Understanding / Participants’ Objectives for the Course (Please come prepared to discuss)
    • Background
    • Industry Context
    • Key Concepts
  • Lecture 2: Quality Risk Management
    • Science Based Quality Risk Management
    • Quality Risk Management Process
    • Initial Risk Assessment
    • Implement & Verify Appropriate Controls
    • Review Risks & Monitor Controls
  • Lecture 3: Life Cycle Approach
    • Computerized Systems Life Cycle
    • Specification & Verification
    • Computerized System Validation Framework
  • Lecture 4: Life Cycle Phases
    • Concept
    • Project
    • Operation
    • Retirement
Day 02(8:30 AM - 4:00 PM)
  • Lecture 5: GxP Compliance
    • Data Integrity
    • Security
    • Defining Electronic Records and Raw Data
  • Lecture 6: Risks & Implementation of Systems
    • Simple Systems (Analytical Balance,pH Meter, Electronic Pipette)
    • Medium Systems (LIMS / ELN)
    • Complex Systems (Robotics)
  • Lecture 7: Supplier Documentation & Services
    • System Development by the Supplier
    • Supplier Assessment
    • Supplier Good Practices
    • Leveraging Supplier Knowledge & Documentation
  • Quiz: Jeopardy!!!!
    • GxP Compliant Laboratory Computerized Systems
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Angela Bazigos

Angela Bazigos
CEO, Touchstone Technologies Inc

Angela Bazigos is the CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety and Turnarounds. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers, Public Health Service. Positions include Chief Compliance Officer, http://morflearning.com/angelabazigos/, QA Director, Director of MIS. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA http://www1.diahome.org/~/media/4FA562336EBD46C58CDC43A8B7773095.ashx. Patent on speeding up software compliance https://www.google.com/patents/US8266578 . Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom http://blogs.wsj.com/riskandcompliance/2015/07/24/using-training-to-bring-compliance-to-boardrooms/ . Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford’s Who’s Who for LifeSciences: http://www.stanfordwhoswho.com/Angela.Bazigos.7144112.html#overview.

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$1,299.00

Seminar One Registration

January 25-26, 2018, San Diego, CA




Early bird seats are limited and based on first-come, first-serve.

Your registration fee includes the workshop, all course materials and lunch.


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Cancellations and substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.

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We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

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Location

San Diego, CA
(Venue to be announced shortly)

January 25-26, 2018

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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

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San Diego Cabrillo National Monument

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

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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

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San Diego Zoo Safari Park

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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 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

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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