ComplianceOnline

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.

Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
Attendance Certificate
$100 Gift Cert for next seminar

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
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Day 01(8:30 AM - 5:00 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
Day 02(8:30 AM - 4:30 PM)
  • 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
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Dr. Ludwig Huber

Dr. Ludwig Huber
Chief Advisor - Global FDA Compliance, 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 by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

Register Now

Online using Credit card

$1,599.00

Seminar One Registration (USD)

March 23-24, 2017, Hong Kong
(Registrations till January 15, 2017 - $1599)
(Registrations till February 20, 2017 - $1799)
(Registrations till March 5, 2017 - $1899)
(Registrations after March 5, 2017 - $1999)

$7,299.00
$9,594.00 (23%)*

Save $2,295.00

Special Group Discount Register for Six attendees (USD)

March 23-24, 2017, Hong Kong
*Hurry! This option is limited and based on availability.
Great Savings with Group Ticket!!! Only 3 left



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

The registration fee includes: the workshop; all related course materials; morning tea/coffee, lunch and afternoon tea/coffee on both days.


For discounts on multiple registrations, contact customer care at +1-888-717-2436.

Other Registration Option

By order form / PO#

Payment Mode

By Check -
Pay your check to (payee name) “MetricStream Inc” our parent company and Mail the check to:

ComplianceOnline (MetricStream, Inc),
2479 East Bayshore Road Suite 200
Palo Alto, CA 94303
USA

By Wire -

Register / Pay by Wire Transfer

Please contact us to get details of wire transfer option.

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.

Location:

Hong Kong
(Venue to be announced shortly)

March 23-24, 2017

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Media Partners
Platinum Partner
  • Logo on name cards
  • Logo placement on the podium
  • Logo on the lanyards for all speakers
  • Exclusive stall at the entrance
  • A full page brochure advert
  • Moving banner ad on the website
Gold Partner
  • Logo on promotional email campaign
  • Logo on name cards
  • A half page brochure advert
  • Exclusive stall at the entrance
  • A quarter page brochure advert
  • Moving banner ad on the website
Silver Partner
  • Logo on name cards
  • Logo placement on the podium
  • Logo on the lanyards for all speakers
  • Exclusive stall at the entrance
  • A full page brochure advert
  • Moving banner ad on the website
Bronze Partner
  • Logo on promotional email campaign
  • Logo on name cards
  • A half page brochure advert
  • Exclusive stall at the entrance
  • A quarter page brochure advert

If you wish to partner with us for this event please contact us: partner@complianceonline.com or call us: +1-888-717-2436.

Sponsors
Platinum Partner
  • Logo on name cards
  • Logo placement on the podium
  • Logo on the lanyards for all speakers
  • Exclusive stall at the entrance
  • A full page brochure advert
Gold Partner
  • Logo on promotional email campaign
  • Logo on name cards
  • A half page brochure advert
  • Exclusive stall at the entrance
  • A quarter page brochure advert
  • Moving banner ad on the website
Silver Partner
  • Logo on name cards
  • Logo placement on the podium
  • Logo on the lanyards for all speakers
  • Exclusive stall at the entrance
  • A full page brochure advert
  • Moving banner ad on the website
Bronze Partner
  • Logo on promotional email campaign
  • Logo on name cards
  • A half page brochure advert
  • Exclusive stall at the entrance
  • A quarter page brochure advert
  • Moving banner ad on the website

If you wish to sponsor this event please contact Cruise Webster: cwebster@complianceonline.com or call us: (207) 576-4173

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

Local Attractions of Hong Kong

Ocean Park Hong Kong

Ocean Park Hong Kong

Ocean Park Hong Kong is a theme park that provides fun for all the family, from tropical rainforests to polar expeditions, and educational exhibits to thrilling roller. With an area of 170 acres, it's one of the largest ocean parks in the world.

Hong Kong Disneyland

Hong Kong Disneyland

Hong Kong Disneyland is a must-see because of its special attractions and the inimitable sense of Chinese culture. The park consists of seven themed areas: Main Street, U.S.A., Fantasyland, Adventureland, Tomorrowland, Grizzly Gulch, Mystic Point, and Toy Story Land.

Hong Kong Ladies Market

Hong Kong Ladies Market

With over 100 stalls of bargain clothing, accessories and souvenirs, the Ladies’ Market on Tung Choi Street provides a one-kilometer stretch on which to practice your haggling skills.

Victoria Peak

Victoria Peak

Victoria Peak is a mountain in the western half of Hong Kong Island. It is also known as Mount Austin, and locally as The Peak. The Peak, Hong Kong's most popular attraction is more than just stunning vistas or great shopping and dining. It's an amazing collection of unique must-visit attractions, providing you with a diverse fun-filled experience of Hong Kong's living culture.

Lantau Island

Lantau Island

Lantau Island is the largest island in Hong Kong, located at the mouth of the Pearl River. Buddhist architecture; fireworks over Sleeping Beauty's castle; a long sandy beach; a mall of shopping outlets – Lantau Island has it all. Whatever your persuasion, Hong Kong’s largest outlying island brings solace to the soul, senses and shopping bags.

Hong Kong Convention

Hong Kong Convention and Exhibition Centre

With its vast curtain of glass and 40,000 square-meter aluminum roof sculpted to echo a seabird soaring in flight, the striking Hong Kong Convention and Exhibition Centre is a major landmark on the Hong Kong Island skyline. Known worldwide as HKCEC, this harbour-front expansion used top-down construction techniques to meet a challenge of limited land supply; its highly innovative methods winning many industry accolades.

Bank of China Tower

Bank of China Tower

The prism-like façade of the 367.4m Bank of China Tower has become one of Hong Kong skyline’s most recognisable and appreciated features. The work of renowned Chinese–American architect I.M. Pei, the 70-storey building's asymmetrical form is pure geometry and has been compared to a bamboo plant, which extends its trunk successively higher with each new burst of growth.

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

We need below information to serve you better

Best Sellers
You Recently Viewed
    Loading