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Stability Programs for Determining Product Shelf Life

  January 20, 2018  
CfPIE - The Center for Professional Innovation & Education, Los Angeles, CA USA
June 25 & 26, 2018

FDA Regulatory Compliance Training

Course Description - Course runs 9:00 to 5:00 both days (Breakfast & Lunch Included)

Quality assurance studies for active pharmaceutical ingredients (APIs) and pharmaceutical drug products, both chemical drugs and biologics, are essential for product quality and patient protection. The goals of the stability program are (1) to determine an appropriate and safe stability profile during clinical development and (2) to justify a shelf-life for the product to enter the market for FDA regulatory compliance,

The approach to stability testing and interpretation of stability data has undergone significant change. Strategic international ICH regulatory guidance’s have been adopted that are driving the entire pharmaceutical industry, including both chemical drugs and biologics, to a higher standard of performance, including Quality by Design (QbD), Quality Risk Management (QRM) and Pharmaceutical Quality System (PQS).

Therefore, it is most important for a pharmaceutical company to have an effective and regulatory compliant stability program strategy that can meet both FDA and EMA requirements and expectations. At each stage of drug development, from Phase 1 through commercialization, the basic question needs to be addressed: ‘What is absolutely necessary from the stability program to be successful in getting the chemical drug/biologic through clinical trials and into the market, but without impacting patient safety or creating delays in the program?' Regulatory compliant deficiencies in stability program have resulted in clinical holds and market approval delays.

Who Should Attend

This two-day course is designed for directors, managers, supervisors, project planners, analysts, and professional staff seeking to understand, develop or implement a regulatory compliant stability program for their pharmaceutical chemical drug or biologic product. Typical attendees include: Management, Project Managers, Regulatory Affairs, Manufacturing, Quality Assurance, Quality Control, Formulation Development and Analytical Development personnel.

This course will help the attendee to design and implement a stability program meeting global stability requirements and expectations. Participants will also become effective in interpretation of stability data.

Organized by: Center for Professional Innovation & Education
Invited Speakers:

Priya Jambhekar

Priya Jambhekar

Specialties: Regulatory, Stability, Biotechnology, Management

Priya Jambhekar is a consultant with EAS Consulting Group and has over twenty years of experience in the areas of product development, product safety, quality assurance, quality compliance, clinical operations, supply chain management and US and international regulatory affairs. She has extensive experience in establishing regulatory strategy for Chemistry, Manufacturing Controls, Clinical and Nonclinical development for 1st in the class products and operational excellence for optimal success during all aspects of pre- and post- approval phases of new drugs, devices and biologics development and marketing of products covering various therapeutic areas, including metabolism and endocrinology, analgesic, anti-inflammatory, cardio-renal, pulmonary, oncology, gastrointestinal, dermatology, neurology, ophthalmology, urology, pain, anesthesia and addiction products. Priya also has significant experience in the generic industry and have successfully defended ANDA applications with Paragraph IV certifications.

Strategies instituted by Priya have led to company getting a 6-month generic market exclusivity for block buster drugs and have maintained 2 player market for extended period of time, pediatric and orphan drug exclusivities. Priya also has extensive experience in handling of controlled substances, DEA and PDMA registrations, post market safety and medical communication and Health Care Compliance. Proven experience in handling FDA pre-approval inspections and product plant compliance. She has managed over 250 NDA / IND / ANDA / PMA / 510(k) projects in various stages of development for registration around the globe (US, EU, Japan, Canada, Asia, Australia, South and Latin America).

Priya has held positions such as Global Sr. VP of Regulatory & Quality at Paramount BioSciences, Global VP at Ethicon, a J&J company and Alkermes. Some of the other positions include Baxter ACC as regulatory head and Bristol-Myers Squibb. Priya was a part of the management team at Cardiovations & GyneCare, J&J companies and Alkermes. Currently, Priya is a part of the management team of several companies advising them on regulatory, quality, supply chain matters and clinical operation.

Priya hold a M.Sc. in Organic & Biochemistry and M.S. in Pharmacy. She is also certified by Regulatory Affairs Professional Society and NJ Pharmaceutical Quality Control and Assurance Society.

Deadline for Abstracts: N/A
Registration: https://www.cfpie.com/ProductDetails.aspx?ProductID=252
E-mail: info@cfpie.com
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