This workshop is organized by the United States Pharmacopeial Convention (USP), and will take place at the Hyatt Regency Mumbai.
The two-day workshop will address the current challenges surrounding the assortment of impurities in chemical medicines. Meant to encourage discussion and debate, the workshop will examine issues related to all aspects of impurities—for example, organic, elemental, residual solvents, non-drug-related impurities, and so on—from compendial and industry perspectives. An update on the development and modernization of relevant USP standards will be presented along with case studies and panel discussions.
Workshop Goals
Addressing the impact of impurities on chemical medicines is imperative in helping to ensure drug products are safe and effective. This workshop aims to address the current challenges surrounding impurities and discuss strategies for control.
Objectives
- Learn about the perspectives on impurities in USP monographs as well as associated ICH and FDA guidelines. Understand limits for impurities in the USP monographs, where acceptance limits come from, and what can be done if they differ from specific company-approved limits. Develop an understanding of how the limits are applied to products with proposed procedures and acceptance criteria.
- Understand the latest updates on USP–NF General Chapters <466> Ordinary Impurities, <1086> Impurities in Drug Substances and Drug Products, and proposed General Chapter <476>.
- Understand the issues associated with USP–NF General Chapter <231> Heavy Metals that resulted in the development of new proposed chapters—<232> and <233>—on elemental impurities. Understand the scope and context of these new general chapters.
- Review guidelines contained in General Chapter <467>.
- Discuss common mistakes and misconceptions. Debate and discuss risk-based strategy concepts when dealing with compliance issues. Understand the emerging technologies for the screening of medicines.
- Learn isolation and characterization of unknown impurities in API/pharmaceutical products.
Who Should Participate
ARD & Q.C & Q.A & R.A. & R.S. personnel, compliance managers, lab managers, production managers, and individuals and consultants in the pharmaceutical industry
Workshop Steering Committee
Dr. Milind Joshi (J.B. Chemicals & Pharmaceuticals Ltd.), Dr. Rajiv Desai (Alembic Pharmaceuticals Limited), Dr. Antony Raj Gomes (Mylan Laboratories Limited), Dr. Jon E. Clarke (USP), Dr. Horacio Pappa (USP), Dr. Leonel M. Santos (USP), Dr. K.V. Surendra Nath (USP–India), Dr. Sameer Navalgund (USP–India), Dr. Jyothi Ganti (USP–India)
Registration Information
Regular Price Information
| Participant Type | Cost | Discounted Rates |
|---|---|---|
| ARD & Q.C. & R.A./R.S. & Q.A. | Rs. 15,000 + service tax | Group discount (4 or more) |
| Group Discount (3 or more) | Rs. 15,300 + service tax | Early Bird: Register by May 26 |
| Group Discount (3 or more) | Rs. 16,200 + service tax | After May 26 |
| Individual Rate | Rs. 17,000 + service tax | Early Bird: Register by May 26 |
| Individual Rate | Rs. 18,000 + service tax | After May 26 |
Location
Hyatt Regency Mumbai
Sahar Airport Road
Mumbai
India
Phone: +91 22 6696 1234
Local Area Information
Hotel Information
If you require overnight accommodations, make your hotel reservation at your earliest opportunity. We encourage you to reserve at the conference hotel, the Hyatt Regency Mumbai.
Hyatt Regency Mumbai
Sahar Airport Road
Mumbai, India, 400 099