ComplianceOnline

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

Results of analytical methods are used as the basis for important decisions during development and manufacturing of pharmaceutical products. All regulatory agencies expect the regulated industry to have procedures in place to ensure suitable levels of reliability, accuracy and precision of such methods. The procedures should cover lifecycle phases from design, development, validation to on-going routine use.

Managing analytical methods and procedures according to the lifecycle approach has been recommended in recent FDA guidance documents and stimuli articles published by the USP. For example, the recent FDA guidance “Analytical Procedures and Methods Validation for Drugs and Biologics” contains a section on Lifecycle Management of Analytical Procedures.

This 2-day workshop will explain the background to the new Analytical Procedure Lifecycle guidelines and give attendees the knowledge needed to implement recommended approaches. Interactive exercises will be included in the workshop.

Learning Objectives:

  • Learn about the regulatory background and recommendations for managing the lifecycle of analytical methods and procedures
  • Understand current and future industry trends: the concept of lifecycle management of analytical methods, recent USP General Chapter 1210 (Statistical Tools for Procedure Validation), and Quality by Design (QbD) principles for method development and validation
  • Learn how to plan, execute and document design, development and validation of methods developed in-house
  • Understand the principles of lifecycle management for compendial procedures and for managing method transfer
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
  • Be able to develop a strategy for analytical procedure lifecycle management
  • Understand risk management strategies throughout the procedure lifecycle
  • Understand the concept of measurement uncertainty
  • Be able to justify and document decisions about type and extend of revalidation after method changes
  • Be able to define and demonstrate FDA, EU, USP and ICH compliance to auditors and inspectors
  • Be able to develop inspection-ready documentation during on-going routine operation
  • Understand what questions will be asked during audits and inspections and how to answer them

Who will Benefit:

  • QA managers and personnel
  • Quality control scientists
  • Method development scientists
  • Analytical chemists
  • Validation specialists
  • Laboratory managers and supervisors
  • Regulatory affairs professionals
  • 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 - 4:30 PM)
  • 08.30 AM - 09.00 AM - Registration
  • 09.00 AM - Session Start
  • Introductions and Agenda Review Lectures and Workshop Exercises
  • Lecture 1 - Regulatory background and guidance
    • The importance of analytical procedures
    • Introduction to lifecycle management of analytical methods
    • USP approach for method validation: in-process revisions to Chapters 1200, 1210 and 1225
    • Learnings from the new FDA, WHO and PDA method validation guidelines
    • Linking the procedure lifecycle to the quality system
    • The importance of risk management (ICH Q9)
    • Lessons from recent FDA Warning Letters
    • Recommendations for risk-based implementation
  • Lecture 2 - The 2015 FDA Method Validation guidance
    • Scope and regulatory status
    • Recommendations for integrated procedure lifecycle
    • Expectations for quality risk assessment, Quality by Design (QbD), Multivariate experiments, system suitability testing, statistics, knowledge management
    • Equipment operational qualification and trend analysis
    • Revalidation vs. ongoing evaluation
  • Lecture 3 - Preparing your laboratory for compliant validation studies
    • Analytical Instrument qualification
    • 21 CFR Part 11/Annex 11 compliance of computer systems
    • Validation of chromatographic data systems
    • Validation and control of Excel spreadsheets
    • Qualification of reference standards and materials
  • Lecture 4 - The lifecycle overview on integrated method development, validation, and ongoing performance verification
    • Advantages of the new approach
    • Key steps for design, development, validation and ongoing performance verification
    • Integrated lifecycle and QbD: similarities, differences
    • Regulatory status of the new approach
    • Integrating method transfer and compendial method verification
    • Application of risk management through the life cycle
Day 02(8:30 AM - 4:00 PM)

  • Lectures and Workshop Exercises
  • Lecture 5 - The analytical target profile
    • Comparison with the scope of current methods
    • Advantages and limitations of the ATP approach
    • Introduction to measurement uncertainty
    • Target measurement uncertainty (TMU)
    • Considerations for establishing an ATP
    • Incorporating current USP, ICH and FDA guidance into the ATP
    • Constructing an ATP for existing methods
  • Lecture 6 - Procedure design and development
    • Knowledge gathering: what and how
    • Risk management: assessment, evaluation and control
    • Analytical control strategy
    • Typical control examples
    • Illustration of controls using Ishikawa (fishbone) diagrams
    • Knowledge management as an important factor in ensuring the acquiring, analyzing, storing and disseminating information
  • Lecture 7 - Procedure Performance Qualification (Validation)
    • Developing a validation/qualification plan and SOP
    • Going through ICH Q2 validation and test parameters:
    • Accuracy, precision, intermediate precision, specificity, LOD, LOQ, linearity, range, robustness
    • Examples for design and execution of test experiments
    • Examples of application-specific acceptance criteria
    • Evaluation of test results: using statistical models
  • Lecture 8 - Ongoing Performance Verification
    • Objective of ongoing performance verification
    • Monitoring method performance: system suitability testing and quality control samples
    • Handling of method changes vs. permitted adjustments
    • Revalidation of analytical methods: when, what to test
    • Handling of out-of-expectation results
    • Continuous improvements
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
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

$1,699.00

Seminar One Registration

February 3-4, 2020, San Francisco, CA
(Registrations till November 15, 2019 - $1699)
(Registrations after November 15, 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

By Check -
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

By Wire -

Register / Pay by Wire Transfer

Please contact us at +1-888-717-2436 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 @ 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.

Online using Credit card

$1,599.00

Seminar One Registration (USD)

April 2-3, 2020, Zurich, Switzerland
Registrations till December 10, 2019 - $1599
Registrations till January 1, 2020 - $1899
Registrations after January 1, 2020 - $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

By Check -
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

By Wire -

Register / Pay by Wire Transfer

Please contact us at +1-888-717-2436 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 @ 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 1:

San Francisco, CA
(Venue to be announced shortly)

February 3-4, 2020

Location 2:

Zurich, Switzerland
(Venue to be announced shortly)

April 2-3, 2020

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

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

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

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