ComplianceOnline

“This education activity has been submitted to the Compliance Certification Board (CCB)® and is currently pending their review for approval of CCB CEUs.”

Analytical equipment should be qualified, and computer systems should be validated to demonstrate suitability for their intended use. To be acceptable to regulatory authorities, electronic records must comply with 21 CFR Part 11, Annex 11 to EU GMPs and more recent data integrity guidance. Recent EU and FDA reports demonstrate that qualification, validation and electronic records are priority areas for inspection. The large number of FDA warning letters and the frequency of EU enforcement action in these areas demonstrate that companies sometimes struggle to understand or implement the regulations.

This 2-day course guides attendees through equipment qualification, calibration and computer system validation processes from planning to reporting. It also explains regulatory requirements in these areas, including EU and US GMPs, as well as data integrity guidance documents from national and international regulatory bodies.

The course not only ensures a full understanding of the regulations and guidelines for equipment and records but helps attendees to develop a risk-based approach to compliance. Interactive exercises will be dispersed into and between the presentations.

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

Learning Objectives:

  • Learn about the regulatory background and requirements for equipment qualification according to USP <1058> and computer system validation according to GAMP 5
  • Be able to explain the difference between equipment calibration, qualification and system validation
  • Learn which equipment/systems need to be qualified or validated
  • Be able to allocate equipment and systems to USP <1058> and GAMP 5 categories and to design and execute qualification/validation protocols accordingly
  • Understand the logic and principles of instrument qualification and system validation from planning to reporting
  • Be able to develop a qualification and validation strategy
  • Understand how to archive raw data from hybrid systems: electronic vs. paper
  • Be able to define and demonstrate regulatory compliance to auditors and inspectors
  • Be able to develop inspection-ready documentation
  • Learn how to ensure, document and audit the integrity of GMP records

Who will Benefit:

  • IT/IS managers and system administrators
  • QA managers and personnel
  • Laboratory managers and supervisors
  • Analysts
  • Validation specialists
  • Software developers
  • Regulatory affairs
  • Training departments
  • Documentation departments
  • Consultants
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Day 01(8:30 PM - 5:00 PM)
  • 08.30 AM - 09.00 AM - Registration
  • 09.00 AM - Session Start
  • 09.00 AM - 09.45 AM - Requirements and approaches for Analytical Instrument Qualification
    • FDA/EU, PIC/S requirements
    • Qualification/calibration issues in FDA inspections
    • USP General Chapter <1058>: Analytical Instrument Qualification
    • The instrument qualification lifecycle
    • Prioritizing calibration/qualification activities
  • 09.45 AM - 10.30 AM - Qualification in Practice
    • User requirement specifications
    • Installation qualification
    • Operational qualification
    • Preparing inspection-ready documentation
  • 10:30 AM - 11:00 AM - Break
  • 11.00 AM - 11.45 AM - Testing and deviation handling
    • Developing test protocols
    • Documenting test evidence
    • Review and approval of test results
    • Handling deviations
  • 11.45 AM - 12.30 PM - Retrospective qualification and Requalification
    • Qualification of existing systems
    • Leveraging past experience
    • Time-based requalification
    • Event-based requalification
    • What and how much to test – risk-based approach
  • 12:30 PM - 13:30 PM - Lunch
  • 13.30 PM - 14.15 PM - 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 PM - 15.00 PM: 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 PM - 15:30 PM - Break
  • 15.30 PM - 16.15 PM - Requirements and approaches for GMP Computer Systems
    • 21 CFR Part 211, Part 11, PIC/S, EU Annex 11
    • Most critical inspection findings
    • Which systems need to be validated
    • GAMP 5: A Risk based Approach to Laboratory Computerized Systems
    • Examples for risk assessment of computer systems
  • 16.15 PM - 17.00 PM - Validation of Laboratory Computer systems
    • Writing a validation project plan
    • Integrating GAMP 5 with USP <1058> for instrument and computer system validation
    • Writing a validation report
Day 02(8:30 AM - 4:00 PM)

  • 08.30 AM - 09.00 AM - Questions and answers from Day 1
  • 09.00 AM - 10.00 AM - Validation and Use of Excel in the QC Laboratory
    • Designing spreadsheets for compliance
    • Validation approach for spreadsheets – single and multiple-use spreadsheets
    • When, what and how much to test?
    • GAMP 5 recommendations
    • How to ensure spreadsheet data integrity
  • 10:00 AM - 10:30 AM - Break
  • 10.30 AM - 11.15 AM - Configuration management and change control
    • The IEEE standard for configuration management
    • The change control process for planned changes
    • Unplanned changes
    • Upgrading software
    • What to test after changes
    • How to document changes
  • 11.15 AM - 12.00 Noon - Periodic revalidation of chromatography data systems
    • The approach and practice of periodic review
    • Using periodic review to reduce frequency of revalidation
    • Criteria for time-based revalidation
    • Incidents requiring revalidation
    • Validation tasks after installing security and other patches
  • 12:00 Noon - 13:00 PM - Lunch
  • 13.00 PM - 13.45 PM - 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 records
    • Archiving of raw data and ready retrieval
  • 13.45 PM - 14.30 PM - Ensuring Integrity and Security of GMP data
    • Most frequent security and integrity issues
    • The importance of electronic audit trails
    • Review of electronic audit trails: who, what, when and how
  • 14:30 PM - 15:00 PM - Break
  • 15:00 PM - 16.15 PM - Auditing Laboratory Computer Systems
    • Using FDA inspection practice
    • Importance of data governance policy and controls
    • Preparing inspection-ready documentation
    • Responding to typical inspectional/audit observations
  • 16.15 PM - 16.30 PM - Wrap up - Final questions and answers
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Mark Powell

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.

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Register Now

Online using Credit card

$1,899.00

Seminar One Registration

February 6-7, 2020, San Francisco, CA
(Registrations till December 20, 2019 - $1899)
(Registrations after December 20, 2019 - $2099)




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 the days.


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

Other Registration Option

By order form / PO#

Payment Mode

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

ComplianceOnline (MetricStream, Inc),
2479 E. Bayshore Road Suite 260
Palo Alto, CA 94303
USA

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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 @ customercare@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 $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.

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

DoubleTree by Hilton San Francisco Airport
835 Airport Blvd,
Burlingame, CA, 94010-9949, USA
Tel: +1 650-344-5500

February 6-7, 2020

How to Reach

General Driving Directions:

Directions from San Francisco International Airport, CA: 4.8 mi.
  • Depart from San Francisco International Airport, CA
  • Take ramp left for US-101 South toward San Jose (2.5 mi.)
  • At exit 419B, take ramp right and follow signs for Broadway (0.2 mi.)
  • Turn left onto Broadway (0.2 mi.)
  • Turn right onto Old Bayshore Hwy / Bayshore Hwy (0.1 mi.)
  • Turn left onto Airport Blvd (0.7 mi.)
  • Arrive at Airport Blvd on the right (0.0 mi.)
Directions from San Jose International Airport, CA: 31.1 mi.
  • Depart Airport Blvd toward Airport Blvd (1.0 mi.)
  • Bear left toward Skyport Dr (0.3 mi.)
  • Keep straight onto Skyport Dr (0.1 mi.)
  • Take ramp left for CA-87 N / Guadalupe Pkwy (0.7 mi.)
  • At exit 9B, take ramp left for US-101 North toward San Francisco (28.6 mi.)
  • At exit 419A, take ramp right and follow signs for Anza Blvd (0.2 mi.)
  • Keep straight onto Anza Blvd (0.2 mi.)
  • Turn right onto Airport Blvd (0.0 mi.)
  • Arrive at Airport Blvd on the right (0.0 mi.)
Directions from Metropolitan Oakland International: 27.5 mi.
  • Depart Airport Dr toward Airport Dr (0.3 mi.)
  • Turn right onto Alan Shepard Way (0.0 mi.)
  • Turn right onto John Glenn Dr (0.5 mi.)
  • Turn right onto Ron Cowan Pkwy (0.0 mi.)
  • Take ramp left for Airport Dr (0.7 mi.)
  • Turn right onto CA-61 / Doolittle Dr (0.9 mi.)
  • Keep left to stay on CA-61 / CA-112 / Davis St (0.5 mi.)
  • Take ramp right for I-880 South toward San Jose (6.7 mi.)
  • At exit 27, take ramp right for CA-92 West toward San Mateo Br (13.1 mi.)
  • At exit 13B, take ramp right for US-101 toward San Jose / San Francisco (4.1 mi.)
  • At exit 419A, take ramp right and follow signs for Anza Blvd (0.2 mi.)
  • Keep straight onto Anza Blvd (0.2 mi.)
  • Turn right onto Airport Blvd (0.0 mi.)
  • Arrive at Airport Blvd on the right (0.0 mi.)

Disclaimer: Directions to the venue above have been taken from the hotel website. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue. ComplianceOnline is not responsible for any inaccuracies in the same.

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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

Media Partner:

Media Partner

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