Meeting Regulatory Requirements (ICH, GMP, USP, FDA) for Analytical Procedures for Pharmaceutical Products: Validation, Verification and Transfer: 2-day In-person Seminar

By: Kim Huynh-Ba, Executive Director of Pharmalytik
Coming soon.. Please contact customer care for new schedule

Course Description:

New medicines are developed every day to meet medical needs and improve quality of life and HPLC methods are widely used in R&D and QC pharmaceutical labs. Analytical methods establish acceptance criteria and monitor quality of drug products throughout their expiry. Therefore, validation becomes a critical process and it is important to understand requirements set forth by multiple regulatory agencies such as the ICH and the FDA.

This course will discuss different aspects of method validation, verification and transfer throughout the life cycle using Quality by Design approach (QbD). It will provide participants with an understanding of regulatory requirements in these areas. It will present critical principles of the transfer process, discuss different strategies and key factors that would influence the transfer, evaluate transfer packages and suggest how to handle transfer failures.

This 2-day comprehensive course will also discuss how to write protocol, establish acceptance criteria and document validation reports.

Learning Objective:

Upon completing this course participants will:

  • Understand GMP requirements for method validation
  • Understand ICH guidelines for validation of analytical procedures
  • Understand strategy options to transfer analytical procedures
  • Design validation protocol for analytical methods
  • Justify acceptance criteria for method validation
  • Understand stability indicating methods
  • Understand specificity and forced degradation studies
  • Implement validation protocols
  • Compile an effective validation report
  • Handle validation failures
  • Understand verification of pharmacopeia methods

Who will Benefit:

This course will benefit professionals involved in working with analytical methods of pharmaceutical products and management involved in making technical decisions in drug development. This includes but not limited to the following individuals:

  • QA/QC analytical chemists
  • QA/QC directors, managers
  • Investigators in QA/QC
  • R&D scientists
  • Project management
  • Manufacturing personnel
  • CROs analysts
  • Technical liaison
  • Regulatory affairs personnel
  • CMC specialists
  • Senior quality managers
  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Quality auditors
  • Document control specialists

Course Outline:

Day One (8:30 AM – 4:30 PM)
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM

I. Regulatory expectations of Method Validation
  1. Current review of critical GMP issues in analytical labs
  2. Common 483s observations and Warning Letters
  3. Review ICH Q2 A&B guidelines
  4. USP <1225> and <1226> requirements
  5. Analytical Method Life Cycle
Interactive Exercise and Discussion: Discuss Warning Letters and 483 violations on method validation

II. Development of stability indicating test methods
  1. Discuss validation characteristics
  2. Stress testing and forced degradation studies
  3. Discuss Q3 for impurities monitoring
  4. Validation process and method Life Cycle
Interactive Exercise and Discussion: Establish method validation protocol for typical drug product
Day Two (8:30 AM – 4:30 PM)
III. Method Transfer Process
  1. Purpose of Analytical Method Transfer
  2. USP <1224> and Strategies of Method Transfer
  3. Phases of Method Transfer
  4. Determine Gap Analysis
Interactive Exercise: Establish checklist for gap analysis

IV. Relationship of Validation, Verification and Transfer
  1. Discuss the relationship
  2. Writing validation protocols and reports
  3. Determine acceptance criteria
Interactive Exercise and Discussion: Determine validation strategy for new product

Meet Your Instructor

Kim Huynh Ba
Kim Huynh-Ba
Executive Director of Pharmalytik

Kim Huynh-Ba has almost 25 years of experience in analytical development, project management, strategic drug development and stability sciences. Ms. Huynh-Ba currently is the Executive Director of Pharmalytik, where she provides consulting and training services to pharmaceutical companies, including companies operating under FDA’s Consent Decree on harmonization and optimization of analytical best practices since 2003. Her clients are from various sizes of pharmaceutical companies in US and abroad. Prior to Pharmalytik, she was the Director of Pharmacopeial Education Department of U.S. Pharmacopeia (USP), where she was responsible for their education programs worldwide. She has held several technical and quality positions at Astra Zeneca (formerly ICI Americas), DuPont Merck, DuPont Pharmaceuticals, Bristol Myers Squibb and Wyeth Vaccines. She is also a short course instructor on cGMP compliance and quality topics for several global organizations such as American Chemical Society (ACS), American Association of Pharmaceutical Scientists (AAPS), Pittsburgh Conference, and many other international training groups. She is an Adjunct Professor at Temple University-School of Pharmacy, Widener University and Illinois Institute of Technology (IIT) teaching pharmaceutical analysis and analytical chemistry graduate courses.

She is a member of the Executive Committee of Governing Board of Eastern Analytical Symposium (EAS) and will be their 2013 President. She is the Chair of USP Good Documentation Practices Expert Panel (2010-15) and a member of USP Impurities of Drug Products Expert Panel (2012-15). She was also a member of USP General Chapter Expert Committee (2010-15), member of USP Reference Standard Project Team and USP Prescription/Non-Prescription Stakeholder Forum of previous cycle. She was a member of the Consumer Healthcare Product Association’s (CHPA) Stability and Impurities Breakout Groups. She currently is a member of AAPS Publication Committee, Chair of the Stability Focus Group and serves on the Steering Committees of CMC and Pharmaceutical Trace Impurities Focus Groups. She is a recipient of the 2008 Service Award of Analysis and Pharmaceutical Quality Section and 2008 Recognition Award of Regulatory Section of AAPS. She also received the 2001 DuPont Pharmaceutical Company Asian American Leadership Award.

She has authored numerous technical publications and book chapters and has spoken extensively, both domestic and internationally, of the compliance and quality areas. She is the editor of the "Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies and Best Practices" (2008) and "Pharmaceutical Stability Testing to Support Global Markets"

Venue

Location:
Hong Kong (Venue to be announced shortly)

June 30- July 01, 2014
Register Online

Register Online

$0
Get the Invitation
Pre-Register yourself and get the official Invite when venue and dates are announced for this seminar.
Call here to register +1-1-888-771-6965 or email at editor@grcseminars.com

Group Registrations

Send Your Team for Maximum Benefit Get your team up to speed!

Significant tuition discounts are available for teams of two or more from the same company. You must register at the same time and provide a single payment to take advantage of the discount.

  • 2 Attendees
  • 3 to 6 Attendees
  • 7 to 10 Attendees
  • 10+ Attendees
  • -
  • -
  • -
  • -
  • Get 10% off
  • Get 20% off
  • Get 25% off
  • Get 30% off
Call Toll Free +1-888-717-6965 if you have any queries.

Register by Wire Transfer

If you wish to pay by wire transfer: Please call us at
Toll Free +1-888-717-6965

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 @ +1-888-717-6965 or email us @ editor@grcseminars.com

Payment:

Payment is required before 2 days of 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 from 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 GRC Seminars 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 GRC Seminars cancels the seminar, GRC Seminars 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 before 5 working days from the seminar date. Please bring the pass to the venue of the event.

Conference photograph / video:

By registering and attending GRC Seminars conference you agree to have your photographs or videos taken at the conference venue and you do not have any objections to use these photos and videos by GRC Seminars for marketing, archiving or any other conference related activities. You agree to release GRC Seminars for any kind of claims arising out of copyright or privacy violations.

Media Partners

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

Media Partner Benefits
  • Logo and company data on the event website.
  • Logo on the conference material distributed during the conference.
  • Media Partner’s brochure distributed along with conference material.
  • Logo on all the mailings before and after the event.
  • 10% discount to media partner's subscribers.
Media Partner to do
  • Banner (min 728x90 or 468x60) on the Media Partner website.
  • Insertion of the event in the event calendar, both printed and/or online.
  • Announcement article of the conference on the Magazine and/or Website.
  • Dedicated email blast to all subscribers of Media Partner.
  • Article on the Magazine and/or Website after the conference.

Sponsors

If you wish to sponsor this event please contact Ben Hobbs: benhobbs@complianceonline.com or call us: (650) 620-2941
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 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
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 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 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 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
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.