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) | Day Two (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
II. Development of stability indicating test methods
|
III. Method Transfer Process
IV. Relationship of Validation, Verification and Transfer
|
Meet Your Instructor
 |
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" |
Register Now
Online using Credit card
Get the Invitation
Pre-Register yourself and get the official Invite when venue and dates are announced for this seminar.
Call here to register +1-888-717-2436 or email at [email protected]
Other Registration Option
- Download the Order Form
- Fill this form with attendee details & payment details
- Fax it to +1-650-362-2367, or
- Email it to [email protected]
Payment Mode
ComplianceOnline (MetricStream, Inc),
6201 America Center Drive Suite 240
San Jose, CA 95002
USA
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 @ [email protected]
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 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 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 ComplianceOnline 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 ComplianceOnline for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline for any kind of claims arising out of copyright or privacy violations.
|
Local Attractions
Coming Soon...
