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GlobalCompliancePanel, Online Training, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA
2014-01-17
Overview: On June 20, 2013 the FDA’s office of Generic drugs (OGD) issued a final guidance entitled, ANDA: Stability testing of Drug substances and Products. In August 2013, OGD issued a draft guidance in the form of question and answers on the stability guidance. These documents cover covers all new ANDAs under the Federal Food, Drug, and Cosmetic Act, section 505 (j), and DMFs (Type II for drug substances that support the ANDAs). It does not apply to post approval changes. The guidance goes in effect on June 20, 2014.
The guidance document is based upon the following existing ICH guidance documents- Q1A (R2) Stability Testing of New Drug Substances and Products.
- Q1B Photo stability Testing of New Drug Substances and Products.
- Q1C Stability Testing for New Dosage Forms.
- Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products.
- Q1E Evaluation of Stability Data.
The goal of this webinar is to provide additional information that will assist in the ease of adoption of the International Conference on Harmonization (ICH) recommended stability guidance's for the submission of ANDAs to OGD. You will also learn about challenges and practical application for adoption of these guidance documents. This webinar will also provide you with the tools to complete the stability section of an ANDAs that will be accepted by the OGD for filing.
Why should you Attend:Since passing of the Hatch-Waxman Act in 1984, this is the most significant and major change in the requirements for supporting submissions of the generic application in US. This guidance has significant cost and time impact on the development of the generic products. It also raises the bar for the performance standards for development of generic products. The manufacturing and generic drug user fees significantly raise the bar for generic entry. It is even more important now to avoid re-do This webinar will cover everything you need to know about the FDA stability guidance of June 2013. You will gain full understanding of stability requirements for drug substance and drug products supporting submission of generic applications. You will know ins and outs of the stability requirements and will be able to train others in your company.
Areas Covered in the Session:- Stability requirements for generic drug substances and products
- FDA June 2013 ANDA stability guidance
- FDA August 2013 ANDA draft Stability guidance - question and answers
- Manufacturing and packaging of stability batches
- Establishment of specifications for stability testing
- Establishment of expiration dating based upon stability data
Who Will Benefit:- Quality Assurance
- External Manufacturing / Contract Manufacturing / Third Party
- Contract analytical laboratories
- Manufacturing / CMC
- Manufacturing Operations
- Product Quality
- Auditing
- Risk Management
- Regulatory Affairs / Compliance
- Technology Transfer
- Process Development / Optimization
- Outsourcing
- Supply Chain
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Organized by:
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GlobalCompliancePanel |
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Invited Speakers:
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Dr. Suggy Chrai is a senior executive with over 30 years of experience in the pharmaceutical and biotechnology industry. Suggy was Vice President, Delsys Pharmaceutical Corporation, Vice President, The Liposome Company, and Vice President, Mova Pharmaceutical Corporation. He grew through the ranks at Bristol-Myers Squibb. At Schering Plough, he started as Senior Scientist and soon became Group Leader in Sterile Formulations Group. In addition to his industrial experience, his 20 years of teaching includes Adjunct Professorship at Fairleigh Dickinson University, Rutgers State University, Long Island University and University of Puerto Rico. He has conducted several courses for various trade organizations. His education includes M.S. and Ph.D. degrees from University of Wisconsin and a B.S. degree in Pharmacy from University of Jadavpur. He also holds a M.B.A. degree from Fairleigh Dickinson University. He is an Editorial Advisory Board Member of several journals and magazines and was an Advisory Panel Member of the United States Pharmacopoeia; Advisory Board Member of Alliance for Minority Participation–Universities of Puerto Rico and is a Board Member of Middlesex County College Foundation.
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Deadline for Abstracts:
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2014-01-17
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Registration:
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Contact Information: NetZealous LLC, DBA GlobalCompliancePanel 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA USA Phone:800-447-9407 Fax: 302-288-6884 webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com
bit.ly/1dISu1J
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E-mail:
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support@globalcompliancepanel.com
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