ComplianceOnline

Register

Toll Free: +1-888-717-2436

CART 0

Your Shopping Cart

Contains 0 items
Total: $0.00
View Shopping Cart
Cart Image



Analytical Instrument Qualification and System Validation

By:
Dr. Ludwig Huber, Director and Chief Editor, LabCompliance
Coming soon.. Please contact customer care for new schedule

Course Description:

Analytical instruments should be qualified and systems should be validated to demonstrate suitability for the intended use. This two day in-person seminar will provide attendees the regulatory background and guidance through the complete process from planning and writing requirement specifications to vendor assessment, installation and operational qualification and ongoing testing during routine use. This interactive workshop will help attendees understand the instrument qualification and system validation processes and will provide templates and examples to develop inspection ready documentation.

Practical examples and interactive exercises will be dispersed into and between the presentations while 50% of the total time will be dedicated to practical sessions. During the seminar, attendees will work in small groups on case studies and prepare the answers using prepared fill-in templates. After the course a large variety of tools such as SOPs, validation examples and checklists will be readily available on a dedicated website that can be used to easily implement what they have learned from the course.



Learning Objectives:

  • Learn about the regulatory background and requirements for laboratory instrument qualification and system validation
  • Understand the logic and principles of instrument qualification and system validation from validation planning to reporting
  • Understand and be able to explain your company’s qualification and validation strategies
  • Be able to independently prepare execute test protocols, this includes setting specifications and acceptance criteria
  • Understand how to review and approve qualification and validation protocols
  • Be able to develop inspection ready qualification and validation deliverables
  • Learn how to avoid and/or respond to FDA inspectional observations and warning letters


Complimentary Hand-outs:

1. 70-page primer - Analytical Instrument Qualification and System Validation (authored by Dr. Ludwig Huber)

2. SOPs

  • Change control of analytical equipment
  • Risk assessment for laboratory systems
  • On-going performance control of analytical equipment
  • Analytical instrument qualification according to USP <1058>
  • Requalification of analytical equipment
  • Calibration of analytical balances
  • Validation of laboratory computer systems
  • Validation of spreadsheet applications for equipment qualification, maintenance and change control

3. Full Set of Qualification examples for an HPLC system

  • Qualification plan
  • Supplier assessment
  • Risk assessment
  • Installation Qualification
  • Operational Qualification

  • Traceability matrix
  • Performance Qualification
  • Validation report
  • Test sheet and approvals

4. Full set of Validation examples of a chromatographic Data System

  • Validation from beginning to end: step-by-step
  • Validation project plan
  • Requirement specifications
  • Risk assessment
  • Vendor assessment
  • Design qualification
  • Test plan
  • Installation qualification
  • Operational qualification
  • Performance qualification
  • Validation report

5. Qualification conditions, frequency of requalification and acceptance limits for 20 laboratory instruments




Who Should Attend

This seminar will be beneficial for the following personnel in pharmaceutical development and quality control laboratories and contract testing laboratories.

  • Laboratory managers, supervisors and analysts
  • QA managers and personnel
  • Quality control unit directors and staff
  • IT managers and staff
  • Consultants
  • Laboratory suppliers of material, equipment and services




Course Outline:

Day One (8:30 AM - 5:00 PM) Day Two (8:30 AM - 4:30 PM)
  • 08.30 AM - 09.00 AM: Registration
  • 09.00 AM: Session Start
  • 09.00 - 09.45: Requirements and approaches for Analytical Instrument Qualification
    • FDA/EU, PIC/S requirements
    • Qualification/calibration issues in FDA inspections
    • USP Chapter <1058>: current and proposed changes
    • The instrument qualification lifecycle
    • Planning for cost-effective calibration/qualification
  • 09.45 - 10.30 (*): Going through the qualification phases
    • Writing requirement specifications
    • Installation and installation qualification
    • Testing for initial operational qualification
    • Leveraging system suitability testing for on-going performance qualification
    • Preparing inspection ready documentation
  • 10:30 - 11:00: Break
  • 11.00 - 11.45 (*): Testing and deviation handling
    • Developing generic test protocols
    • Documenting test evidence
    • Going through an example test protocol
    • Review and approval of test results
    • Handling deviations
  • 11.45 - 12.30: Retrospective qualification and Requalification
    • Qualification of existing systems
    • Leveraging past experience
    • Time based requalification
    • Event based requalification
    • What and how much to test
  • 12:30 - 13:30: Lunch
  • 13.30 - 14.15 (*): Equipment Maintenance and Change control
    • Preventive maintenance; tasks, documentation
    • Planned and unplanned changes
    • Changing hardware, firmware, documentation
    • Definition and handling of like-for-like changes.
    • Handling changes made by vendors
  • 14.15 -15.00 (*): Type and extend of qualification for USP Instrument Categories
    • The approach and benefits of instrument categories
    • How to identify the correct category: A, B, C
    • Type and extent of qualification for each category
    • Required procedures and qualification deliverables
    • Responsibilities for instrument qualification
  • 15:00 - 15:30: Break
  • 15.30 - 16.15 (*): Requirements and approaches for Laboratory Computer Systems
    • FDA Part 211, Part 11, PIC/S Annex 11
    • Most critical inspection findings
    • Which systems need to be validated
    • Learning from the new GAMP® guide: “A Risk based Approach to Laboratory Computerized Systems”
    • Examples for risk assessment of computer systems
  • 16.15 - 17.00 (*): Validation of Laboratory Computer systems
    • Writing a validation project plan
    • Going through a complete laboratory computer system validation from beginning to end
    • Integrating the GAMP® guide with USP <1058> for integrated instrument and system validation
    • Writing a validation report as a mirror to the plan
    • Preparing inspection ready validation documentation

  • 08.30 - 09.00: Review of day
    • Questions and answers from Day 1
    • Main conclusions and action items
  • 09.00 - 10.00 (*): Validation and Use of Excel in the QC Laboratory
    • Designing spreadsheets for compliance
    • Validation approach for spreadsheet applications
    • When, what and how much to test?
    • Recommendations from GAMP®5 for testing native Excel functions
    • How to ensure spreadsheet and data integrity
  • 10:00 - 10:30: Break
  • 10.30 - 11.15 (*): Configuration management and Change control
    • The IEEE model for configuration management and change control
    • The change control process for planned and unplanned changes
    • Versioning of software and computer systems
    • What to test after changes
    • How to document changes
  • 11.15 - 12.00 (*): Periodic review and revalidation of chromatographic data system
    • The approach and practice of periodic review
    • Using periodic review to reduce frequency of revalidation
    • Criteria for time based revalidation
    • Incident requiring revalidation
    • Validation tasks after installing security and other patches
  • 12:00 - 13:00: Lunch
  • 13.00 - 13.45 (*): Handling raw data and other laboratory records
    • Definition of raw data: electronic vs. paper
    • Acquisition and recording of raw data
    • How to make accurate and complete copies of raw data
    • Changing of data and other records
    • Archiving of raw data and ready retrieval
  • 13.45 - 14.30: Ensuring Integrity and Security of Laboratory (Raw) data
    • Most frequent security and integrity issues: going through recent 483's, EIRs and warning letters
    • The importance of electronic audit trail to document data integrity
    • Review of electronic audit trail: who, what, when and how
    • Examples how to ensure and document data integrity
  • 14:30 - 15:00: Break
  • 15:00 - 16.15 (*): Auditing Laboratory Computer Systems and records for FDA Compliance
    • Using FDA Inspections as model for laboratory audits
    • Going through a typical FDA computer system inspection
    • Preparing inspection ready documentation
    • Responding to typical inspectional/audit deviations
    • Learn how to avoid or respond to FDA 483s and warning letters
  • 16.15 - 16.30: Wrap up – Final questions and answers



Note: Sessions indicated with (*) include one or more workshop exercises.

®GAMP is a registered trademark and stands for Good Automated Manufacturing Practice



Meet Your Instructor

Dr. Ludwig Huber
Director and Chief Editor, LabCompliance

Dr. Ludwig Huber is Director and Chief Editor of www.labcompliance.com, the global on-line resource for validation and compliance issues for laboratories . Mr. Huber is an expert for FDA and equivalent international compliance and for ISO/IEC 17025 laboratory accreditation. He is also the Chairman, presenter and panel discussion member at US-FDA industry training sessions and conferences.

He served as a team member of PDA's task forces "21 CFR Part 11", of US-FDA internal documents, and of the GAMP® special interest group on laboratory equipment. In addition, he was awarded as Presenter of the Year of the Institute for Validation and Technology. He is the author of the books “Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Interpharm Press.

For more information, visit www.ludwig-huber.com





Register Online


Get the Invitation
Pre-Register yourself and get the official Invite when venue and dates are announced for this seminar.
Call here to register +1-888-717-2436 or email at customercare@complianceonline.com


Register by P.O. / Check


Yes, I want to attend "Analytical Instrument Qualification and System Validation".

If you are paying by check:

Checks should be payable to MetricStream Inc. (our parent company) and mailed to:
2479 East Bayshore Road
Suite 200
Palo Alto, CA 94303
USA

Group Registrations

Significant tuition discounts are available for teams of two or more from the same company. You must register at the same time and provide a single payment to take advantage of the discount.

2 Attendees - Get 10% off
3 to 6 Attendees - Get 20% off
7 to 10 Attendees - Get 25% off
10+ Attendees - Get 30% off

Register by Wire Transfer




Terms & Conditions to Register for the Seminar/Conference/Event

Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ editor@complianceonline.com

Payment:
Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).

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 $200 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 ($200) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

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.

Attendance confirmation and documents to carry to the seminar venue:
After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.

Conference photograph / video:
By registering and attending ComplianceOnline conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.

Media Partners

Sponsors



Media Partner Benefits
  • Logo and company data on the event website.
  • Logo on the conference material distributed during the conference.
  • Media Partner’s brochure distributed along with conference material.
  • Logo on all the mailings before and after the event.
  • 10% discount to media partner's subscribers.


Media Partner to do
  • Banner (min 728x90 or 468x60) on the Media Partner website.
  • Insertion of the event in the event calendar, both printed and/or online.
  • Announcement article of the conference on the Magazine and/or Website.
  • Dedicated email blast to all subscribers of Media Partner.
  • Article on the Magazine and/or Website after the conference.







Local Attractions

Since 1973, Singapore Zoo has been known for having among the most beautiful wildlife park settings in the world, where animals roam freely in open and naturalistic habitats. The Singapore Zoo spans 28 hectares within Singapore's heavily forested central catchment area. The zoo, which attracts about 1.6 million visitors per year, boasts 315 animal species, some of 16% of which are considered threatened species.




The Night Safari is the world's first nocturnal zoo and is one of the most popular tourist attractions in Singapore. Today, the award-winning park welcomes more than 1.1 million visitors a year. They come from all over the world to enjoy the unique experience of seeing over 2,500 animals in their naturalistic nighttime habitats.



Universal Studios Singapore is the first and only theme park in Southeast Asia. Go beyond the screen and Ride The Movies™ at Universal Studios Singapore. Only here can you experience cutting-edge rides, shows, and attractions based on your favorite blockbuster films and television series, including TRANSFORMERS The Ride: The Ultimate 3D Battle, Shrek 4-D Adventure, Madagascar: A Crate Adventure, Jurassic Park Rapids Adventure, and more!




The Singapore Flyer is a giant Ferris wheel in Singapore that was constructed between 2005 and 2008. Described by its operators as an observation wheel, it reaches 42 storeys high, with a total height of 165 m (541 ft), making it the world's tallest Ferris wheel, 5 m (16 ft) taller than the Star of Nanchang and 30 m (98 ft) taller than the London Eye.




Underwater World, Singapore is Asia's largest tropical oceanarium and one of Singapore's most popular tourist attractions. Opened in 1991, it has more than 2,500 marine animals of 250 species from different regions of the world. It is also involved in several environmental and educational projects, such as the Living in the Ocean Programme, Ocean Ambassador Programme and the Coral Club.




Boat Quay is a zone offering an eclectic mix of high end restaurants and alfresco dining and lively bars and pubs. Boat Quay is arguably the favorite place to “chill out” for most professionals and expatriates. Lot of options available for drinks, dining from across the world. Most popular are the dining bars along the river. After a nice dinner one can head to one of the many pubs and discs around.




Sentosa is a popular island resort in Singapore, visited by some five million people a year. Attractions include a 2 km (1.2 mi) long sheltered beach, Fort Siloso, two golf courses, two five-star hotels, and the Resorts World Sentosa, featuring the theme park Universal Studios Singapore.






Follow us :
We need below information to serve you better