Analytical Method Validation and Transfer : An Interactive Workshop to Assure Your Test Method Validations Pass FDA and international regulatory agency Scrutiny

By: Kelly Thomas, Vice President, Americas Quality Operations at Stallergenes Greer.
Product code: SEM47
Location 1: Raleigh, NC Feb 06 - 07
Location 2: San Diego, CA Mar 20 - 21

Description

Course “Analytical Methods Validation and Transfer for FDA Compliance" has been Pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

"Each attendee will receive 2-Day workshop materials by the speaker. Seminar Also Includes Certificate, Complimentary Breakfast, Lunch & High Tea/Coffee provided by WCS"

Why have Thousands of companies received warning letters for laboratory control and out-of-specification violations?
 
Improper analytical method validation testing
 
MARKET NEED FOR THIS WORKSHOP:
 
Drug ,biologics and  pharmaceuticals manufacturing is a job for perfectionists.
 
Thousands of analytical tests are at its heart -- sometimes Hundreds of thousands -- that must be validated and/or verified according to strict FDA protocols and international regulatory agency expectations.
 
And a warning letter isn't the only consequence of a poor validation system. False passes, poor reducibility, late shipments and production disruptions are all risks you face without a proper validation process in place.

This course provides guidance on how to perform QC analytical test method validations and transfers. One of the most critical factors in developing and marketing pharmaceutical drug substances and drug products is ensuring that the analytical methods used for analysis can generate valid data upon which business and regulatory decisions can be made. FDA, ICH and USP have each recognized the importance of this relative to the drug development process and have each expanded method validation requirements in recent years. However, with only limited guidance, industry has been left to interpret how to adequately comply with the regulations. This course provides a comprehensive overview of the international regulatory authority requirements and expectations for test method validation of these assays. This course will prepare attendees with the knowledge and tools to plan and execute test method validation packages for the NDA, BLA and MAA market application dossiers, covering in-process, release and stability assays commonly used by QC. 

Whether involved in method development, method validation, method verification or method transfer, this course will provide a broad understanding and “hands-on” knowledge of the method validation process and the difficulties encountered in validating methods to comply with today’s upgraded FDA CDER requirements. Lectures will include some of the more common mathematical and statistical treatments of validation data. Because of the tremendous effort that can be expended in conducting validation studies, efficiency of experimental design and documentation will be stressed throughout the discussions.

Methods utilized for the analysis of pharmaceuticals generate critical data in the determination of a product’s safety, identity, strength, purity, and quality.  It is essential that the quality of the data is assured.  Validation is required to demonstrate that these analytical methods are fit for their intended use.  The validation data is also required by regulatory agencies for submissions.  

This course will provide a thorough review of regulatory guidelines on method validation and transfer.  Each element required to have a complete and thorough method validation will be discussed in detail to ensure course attendees have a clear understanding of each requirement.

A review of validation protocol requirements and selection of appropriate acceptance criteria will also occur during the webinar session; as well as, a discussion on how to select suitable statistical calculations for reporting and interpreting the data

 

Areas Covered

Topic 1: Regulatory Requirements/Guidance on Analytical Method Validation
Topic 2: Analytical Method Pre-Validation – Stage 1
Topic 3: Analytical Method Validation Characteristics – Stage 2
Topic 4: Test Method Validation Protocol
Topic 5: Test Method Validation Report
Topic 6: Regulatory Concerns About Test Method Validations

Who will Benefit

•          Analytical Development
•          Quality Assurance
•          Quality Control
•          Validation 
•          Regulatory Affairs
•          R&D  
•          Technical Operations
•          Regulatory affairs personnel responsible for the review of such data will also benefit from this course.

Learning Objectives

Pharma , Medical Device & Biotech 

Course Outline:

Day One (8:30 AM – 4:30 PM)

Topic 1: Regulatory Requirements/Guidance on Analytical Method Validation

•        Terminology defined: qualification, validation, revalidation and verification
•        FDA, EMA, ICH requirements and guidance
•        Validation lifecycle for analytical methods

Topic 2: Analytical Method Pre-Validation – Stage 1

•       Analytical Target Profile (ATP)
•       ICH Q8, Q9 and Q10 adherence - Pre-Validation Requirements
•       QC instrumentation qualification
•       Training
•       Critical assay reagent qualification

Topic 3: Analytical Method Validation Characteristics – Stage 2

•       Specificity, accuracy, precision, linearity, range
•       LOD and LOQ
•       Robustness and stability-indicating
•       Value of system suitability controls

 

DAY TWO (08:30 AM to 04:00 PM)

Topic 4: Test Method Validation Protocol

•      Elements of a validation protocol
•      Pre-planning and planning steps
•      Identification and documentation of assay characteristics needing to be validated
•      Critical importance of assigning pre-defined acceptance criteria

Topic 5: Test Method Validation Report

•      Elements of the validation report
•      Elements of the validation protocol and the associated final validation report
•      Meeting the pre-defined acceptance criteria
•      Handling deviations/OOS’s, when (not if) they happen

Topic 6: Regulatory Concerns About Test Method Validations

•      Validation issues identified during the review of the submitted market dossier
•      Validation issues identified during regulatory inspections
•      Test method validation “continuous improvement” – ICH Q10

 

speaker

Kelly ThomasVice President, Americas Quality Operations at Stallergenes Greer

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations.  Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.  
Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.

06-February-2019 To 07-February-2019 Raleigh, NC
Seminar One Registration
$ $1596

$ $1596
20-Mar,2019 San Diego, CA

Special Group Discount Register for Four attendees
$ $4796

Please call any of our customer support on 844-267-7299 to avail the below discount for your Group

2 Attendees - 5% off

3 to 6 Attendees - 10% off

7 to 10 Attendees - 15% off

10+ Attendees - 20% 0ff

Other Modes of Payment

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Venue to be announced shortly Raleigh, NC

How to Reach

Venue to be announced shortly Raleigh, NC

How to Reach

Testimonials

I have attended various seminars from WCS but this "Live" one was incredible. This seminar was excellent.

Pfizer Quality Manager

I liked WCS training style. WCS speakers gave excellent examples to back up what speaker was explaining. Which helped me grasp a better understanding."

RA/QA Manager Abbott

The presenter was excellent session leader, very knowledgeable and well-spoken. The topic was well chosen and interaction between the participants and the presenter was good.

Chief Compliance Officer
 

This was an informative seminar. Provided very valuable insight into how the FDA works. Presenters' experience in real life events and interaction with the FDA is priceless.

Quality Assurance Medtronic

“I enjoyed the training, the instructor was engaging and were able to modify the course to make it more applicable for small group.”

Peter Belsito, Director of Quality TSI

Awesome material covered.  Andbero Magleo, IT Admin Passy-Muir

“Very informative with enough details to start putting together action plans. Susan Murphy, Associate Director, Quality investigation (QA) LFB USA

“I learned a lot from the instructor and trainee good.” David QU, senior Analytical Chemist Dalton Pharma Services.

 

“Well placed, a lot of good information. Good interaction between participants. Held at a good location. More was US based examples given.” Nicola Mootoo, Senior Validation Engineer Shire Pharmaceuticals

 

“Well delivered seminars, right place, good contents.” Evelyn Chang, Corporate manager Genzyme.


“I though the contents of the presentation and the discussion was very good.”Mary Beird, Regulatory Compliance Manager Charles River laboratories International, Inc.

 

“Great session. I learned a lot” Chief HR Professional"

“Wow!  I had an opportunity to attend the HR audit workshop.  It is spectacular and I found it very valuable.
It will help us audit and manage strategic HR issues.” The president of a major insurance and risk management agency.

“I found the audit session very useful; it will help us identify and manage key HR management issues.” A senior auditor

“The session provided important information about HR auditing. It will help us audit critical HR issues and outcomes
 and will help us assess the organization’s culture and values.” A Chief Internal Auditor

“I’ve been doing a lot of research lately on HR audits, trying to find the best system for us.
This session and ELLA seems to really fit the bill for us.” A human resource manager

 

Media Partners

Top Media Partners and Sponsors World Compliance Seminars WCS


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Morf Media, Inc. is shaping the future of enterprise compliance training for the mobile workforce. For the first time, a digital compliance training system, Morf Learning™, provides one to one training to millions on a smart phone or tablet. Now in pilot with more than 100 major companies in the financial services and life sciences industries, Morf Learning is proving to be cost-effective and engaging. Morf Learning delivers three-minute mini lessons with a personalized Virtual Coach™ developed using the Octalysis framework designed by world-renowned gamification leader, Yu-Kai Chou. 


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partner@worldcomplianceseminars.com or speak with one of the account manager + 844 267-7299


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$2,000 - Silver Sponsor Package Includes

Company name and logo on all materials related to events, and prominent location on WCS web site and event media releases 

Listing in monthly Community Leader newsletter sent to over 50,000 users. 

1 Free Pass for the 2 Day Workshop

Sponsors materials will be distributed onsite to all the attendees


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$4,000 - Silver Gold Package Includes

Company name and logo on all materials related to events, and prominent location on WCS web site and event media releases 

Listing in monthly Community Leader newsletter sent to over 50,000 users. 

2 Free Pass for the 2 Day Workshop

Sponsors materials will be distributed onsite to all the attendees

15-20 minutes product demo during the live session

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