ANALYTICAL PROCEDURES &
METHODS VALIDATION

AGENDA

1:30 PM
Lifecycle Management of Analytical Procedure and Methods Validation – FDA Perspective

Peju Odunusi, Ph.D., Owner, Pj Pharmaceutical Consulting



3:00 PM
Ensure Analytical Procedures and Methods are Fit for Purpose when Data Integrity is Essential

Heather Longden, Snr Marketing Manager and Isabelle VuTrieu, Pharmaceutical Market Development Manager, Waters Corporation



7:30 - 8:15 AM
Implementation of cGMP Training – For the QC Scientist

Maria E. Orpilla, Senior Associate, Quality CMC, Nevakar Inc.



8:30 - 10:00 AM
Life Cycle Management of Analytical Procedures – A Roadmap

Kim Huynh-Ba, Managing Director, Pharmalytik; Adjunct Faculty, RAQA Graduate Program, Temple University; Council of Expert, USP



10:30 - 12:00 PM
Test Method Validation — Risk Assessments and Mitigation Tools

Ronald D. Snee, Ph.D., Founder and President, Snee Associates, LLC.



12:00 PM
System Suitability Tests (SST) – Good Analytical Science

Stan Alekman, PhD., Independent Pharmaceutical Consultant, S.L. Alekman Associates, Inc.



1:15 - 2:45 PM
Critical Elements for Analytical Method Transfer

Peju Odunusi, Ph.D., Owner, Pj Pharmaceutical Consulting



3:15 – 4:45 PM
Validation of Stability-Indicating Analytical Methods

Commissioning Agents, Inc. (CAI)



7:30 - 8:15 AM
Determine Calibration Curves Using Regression Analysis

Raul Soto, Senior Principal Engineer, Johnson & Johnson Vision Care



8:30 - 10:00 AM
OOS/OOT Investigations for Analytical Testing and Stability Studies

Junghae Scott, Principal, J Scott Consulting



10:30 - 12:00 PM
Verification of Compendial Methods

John J. Long, Ph.D., Analytical Integrator, Biologics QC, Teva Branded Pharmaceuticals



12:00 PM
System Suitability Establishment in and risk management Purity Methods for Protein Analysis

Liang Jia, Senior Manager, CMC Analytical, NGM Biopharmaceuticals



1:15 - 2:45 PM
Root Cause Investigation to Overcome Analytical Method Transfer (AMT) and Validation (AMV) Challenges

Yasaman Bahreini, Validation and QA senior Consultant, Azzur Group



3:15 – 4:45 PM
Improper Use of Statistics – The Misuse, Misinterpretation and Bias of Analytical Assay Data

Douglas B. Brown, Ph.D., Senior Scientist, Methods Development and Validations, Charles River Laboratories, Inc.



SPONSORS




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Azzur Group

A nationwide network of experts delivering professional services across the life sciences industry, Azzur Group is dedicated to providing clients with efficient, innovative quality and compliance solutions from Discovery to Delivery™. With more than 250 industry partners, including 80% of the top pharma/biotech manufacturers in the U.S., Azzur Group provides carefully calibrated and efficiently executed project management, process engineering, and compliance services. As one of the fastest growing private companies in America, Azzur Group provides clients with the consulting, facility solutions, engineering, validation, IT, technical, training, and laboratory services and solutions they need to remain innovative and competitive. Website: https://www.azzur.com/
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CAI

Fundamentally we exist for one reason: To accelerate our clients’ path to success. Our approach is simple; we put the client’s interests first. We don’t stop until it’s right. And we’ll do whatever it takes to get there. Website: https://commissioningagents.com
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Ellab

Since 1949, Ellab is a leading manufacturer of a full line of wireless, real-time data loggers and wired thermocouple validation systems with temperature, humidity, pressure, vacuum, conductivity and CO2 sensor options. Additionally, Ellab offers temperature standards, calibration dry blocks and liquid baths, custom fittings, accessories, and thermocouples. We also offer on-site qualification, validation and calibration services for thermal validation processes ranging from -196°C to 400°C. Typical environments often include -80°C freezers, incubators, stability chambers, autoclaves, and ovens. Website: https://www.ellab.com/




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CIMINFO Software

CIMINFO’s LabMonitor software brings legacy lab applications into Part 11 compliance. Other solutions include Part 11 controls for Spreadsheets, Document and Quality Management, Training and an Inventory System for data integrity assessments. With over 20 year of experience, CIMINFO products are trusted by hundreds of FDA-regulated firms in over 30 countries. Website: https://part11solutions.com/
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H&A Scientific

H&A Scientific, Inc. is a scientific software development firm specializing in pharmaceutical industry support. We develop, validate, and market quality computing systems for scientific data acquisition, processing, and data management. We have been creating programs for the laboratory since 1992. Our products have been designed under our Quality System to adhere to the current GAMP guidelines. We develop Quality Software products based on the needs of pharmaceutical companies subject to the constraints and compliance of the Food and Drug Administration (FDA). Our flagship product, SLIM, is a commercial off-the-shelf solution for total management of a company's drug stability program. Website: http://www.hascientific.com/en/
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Neva Analytics

Neva Analytics provides contract analytical services to the pharmaceutical and biotech industries. Our laboratory works with pharmaceutical companies and compounding pharmacies during all stages of development to help bring their products to market. We provide custom analytical services tailored to our client's needs. Founded on over 20 years of pharmaceutical industry experience, we know what it takes to develop methods, test and release your product. Your time is valuable so we pride ourselves on quickly responding to your analytical needs. We set the standard for quickly responding to our client’s requests and providing the highest quality results so our clients can advance critical therapies. Website: http://nevaanalytics.com/
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Novatek International

Novatek International provides a new breed of all-encompassing, process-driven LIMS and other software solutions that target the pharmaceutical, biotech and other health-care industries. Our unique portfolio of out-of-the-box, easy to use software solutions features specialized modules that help you manage all aspects of your quality environment with less effort and time. Novatek delivers solutions that go beyond LIMS for total enterprise wide automation. Website: https://ntint.com/
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QACV

QACV offers comprehensive quality assurance, compliance, and computer validation consulting services to meet your regulatory needs. We provide professional consulting services to FDA regulated life science industries and use proven methodologies to achieve sustainable compliance for your organization. Website: http://www.qacvconsulting.com/
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Waters Corporation

From the everyday consumer to scientists in the laboratory, we all rely on accurate information to make critical decisions. Waters Corporation is the world's leading specialty measurement company focused on improving human health and well being through the application of advanced analytical science technologies. Website: http://www.waters.com

Analytical Procedures & Methods Validation


The time has never been greater to stay up-to-speed with current regulatory thinking. Between FDA’s interest in releasing guidance’s the last few years on Analytical Procedures & Methods Validation, Bioanalytical Methods Validation and a flurry of global regulations on data integrity, it is critical for you and your company to receive the training you need and avoid regulatory action. FDA, ICH and USP all recognize Analytical Development and Validation as top priority in the drug development process and each have respective guidance, albeit interpretation is left to industry. Not only does this event take a deep dive into how companies comply with regulations, but also showcases how leading companies develop methods, validate procedures and generate data and information that lead to critical business decisions. This conference takes participants through a best practice journey through the development, validation and transfer of analytical methods.


Choose From Over 25 Tutorials Addressing Today’s Top Analytical Challenges

 

Analytical Procedures and Methods Validation Highlights Include:

  • Adopt a Systematic Approach for Method Robustness with Effective Design of Experiments (DoE)
  • Evaluate Performance through Analyzing Samples from In-Process through the Finished Product
  • Define and Develop the Content and Scope of Analytical Procedures Program
  • Conduct Suitability Tests and Establish Acceptance Criteria for System Functionality Excellence
  • Develop a Roadmap for Analytical Methods Validation
  • Evaluate Characteristics through Statistical Analysis of Validation Data
  • Development and Validation of a Stability-Indicating Analytical Method
  • Learn How to Perform Risk-Based Evaluations
  • Post Marketing Change Control Procedures for Approved NDA, ANDA and BLA
  • Handle the FDA Laboratory Methods Verification Process
  • Effectively Manage Transfer Studies and Protocols

Maximize Your Training! Laboratory Data Integrity Compliance Congress Highlights Include:

  • Develop, Implement and Maintain Data Integrity Protocols in the GMP Lab
  • Conduct a GAP Analysis and Identify Root Causes
  • Conduct an Laboratory DI Audit Enterprise-Wide
  • Ensure the Reliability and Completeness of Analytical Data
  • Discover the Impact of Human Behavior
  • Implement Risk Management Protocols, Perform Assessments and Continually Verify
  • Prepare for and Handle FDA DI Investigations
  • Understand Requirements and Handle Audit Trail Reviews

 

Personnel in the Following Environments Should Attend:

  • Validation
  • QA/QC
  • Scientist
  • Chemist
  • Laboratory Management
  • Regulatory Affairs
  • Data Integrity

This event is also appropriate to business development and sales managers that offer innovative solutions for QC laboratory management, validation departments, data collection and statistics.

Pricing & Registration

For An Additional $995, You Can Earn 1.5 Graduate Credit Hours Towards Temple’s RAQA Graduate Program! For More Information, Email INFO@KENX.ORG, Call 856-281-7134 or Register Above.