Forced Degradation Masterclass
Overview
Forced degradation, by definition, means subjecting drugs and/or their packaged products to harsher conditions of catalytic external and internal factors, such as heat, moisture, pH, oxidants, metal species, light, etc. These studies help in development of stability-indicating methods that can detect the loss of the active component and rise in degradation products.
Forced degradation requirements have been briefly described in various international guidelines. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has published a set of guidelines, that were discussed, agreed upon and adopted by the US, European and Japanese regulatory authorities. The ICH guidelines that mention of forced degradation requirements are:
• ICH Q1A(R2) – Stability Testing of New Drug Substances and Products
• ICH Q1B – Photostability Testing of New Drug Substances and Products
• ICH Q2B – Validation of Analytical Procedures: Methodology
This specially designed masterclass is intended to provide a holistic understanding of the forced degradation requirements, benefits and advancements. Further, the widely applicable industry practices and handling of regulatory deficiencies will also be covered. The agenda features multiple Q/A sessions to ensure that the participants are amply able to interact with the Experts and get all their queries resolved.
This masterclass will be conducted physically on October 14, 2022, in Sheraton Hyderabad Hotel, Gachibowli, Hyderabad from 9.00 am to 5.00 pm with tea and lunch breaks provided as per the agenda.
Who Should Attend
Industry professionals from Analytical R&D, Quality Assurance and Regulatory departments working in API and Formulation manufacturing companies.
What Will I Get
1. Complete understanding about importance and scientific aspects of forced degradation
2. Protocol for characterization of degradation products using sophisticated hyphenated techniques
3. Quantitation and mass balance during forced degradation
4. Industry practices and handling of queries/deficiencies related to stress testing and suggested solutions
Conference Date
14-10-2022
Conference Agenda
- Regulatory perspectives, benefits and advancements
- Characterization of degradation products
- Quantitation of degradation products
- Forced degradation practices in industry
Speakers & Panelists
Venue
Sheraton Hyderabad Hotel
Address: Rd Number 2, Financial District, Gachibowli, Nanakaramguda, Telangana 500032
Hotel Overview
Enjoy a refreshing travel experience at Sheraton Hyderabad Hotel. Ideally situated in Gachibowli's bustling Financial and Information Technology District, puts you close to all of the area's leading global corporations and convention centers. The upscale property offers an inventory of 272 well-appointed comfortable rooms, including 17 suites and 56 fully serviced apartments. Make time to work out in their fitness center, visit their spa or go for a swim.
This 5-star hotel's popular restaurants are convenient gathering spots for guests, whether meeting for drinks, a meal, or our delicious Sunday brunch. If a business event, wedding, or social function brings you to our hotel, you'll find that their expansive venues, unsurpassed services, and custom catering will make your event an impressive success. Whether traveling for work or on a vacation, the hotel looks forward to greeting you at Sheraton Hyderabad Hotel.