About Anand Pharmacy College (APC) ANAND PHARMACY COLLEGE is one of the leading institute of Gujarat established in 1998 by Shri Ramkrishna Seva Mandal. The institute is conducting All India Council for Technical Education (AICTE), New Delhi approved courses since 1998. Anand Pharmacy College offers B.Pharm, M.Pharm in Pharmaceutics, Pharmacology, Pharmaceutical Quality Assurance, Industrial Pharmacy & Pharmaceutical Technology and Ph.D. courses. The institute is reaccredited by NAAC-UGC (Grade A with CGPA 3.06) and accredited by NBA (UG Course). The institute regularly invites learned and eminent entrepreneurs, academicians, industrialists and dignitaries to deliver lectures and create an environment of enthusiasm and zeal among students and staff members for educational excellence.
Preamble
"Quality cannot be tested into products, it should be built in, or by design". With this notion, we bring to you a comprehensive skill enhancement national seminar on Quality by Design (QbD) as well as introduction of new ICH Q12 guideline for enhancement of pharmaceutical professionals knowledge which lead to enhance the problem solving capacities of product development to life cycle management. QbD is a scientific, risk based, holistic and proactive approach for the development of Pharmaceutical products. It is an systematic effort from product conception through commercialization. Quality metrics will help the FDA develop compliance and inspection policies and practices, and inform risk-based scheduling of drug manufacturing facilities, which can result in a decrease in inspection frequency for high performers. Lifecycle Management and Innovation which will be covered in ICH Q12; the current topics regarding drug application submissions, postapproval changes, aging facilities, process validation, combination products, and quality risk management. With India being the home to the highest number of FDA approved plants outside USA, it becomes evident that both the academic and industrial domains become wellversed with the concept and execution of QbD as well as new ICH Q12 guideline. QbD knowledge will help in identifying and justifying target product profiles, product and process understanding thereby helping in continuous product improvement. Hence this seminar can go a long way in helping us to get skilled and stay up to date with the latest trends in the pharmaceutical industry.
ONE DAY NATIONAL SEMINAR ON
CURRENT STATUS & PERSPECTIVE OF QBD: PRODUCT DEVELOPMENT TO LIFE CYCLE MANAGEMENT AT
ANAND PHARMACY COLLEGE
28th September, 2018
Sponsored by: Student Startup & Innovation Policy (SSIP)
Learning Outcomes
By attending this Seminar participants will learn
• Essential elements of QbD, and Designing of Experiments (DoE)
• Development of Design Space: Risk Reduction of CMAs &/or CPPs.
• Quality Metrics (QM) – Introduction to QM and calculation of the FDA suggested quality metrics.
• ICH Q11 and Q12 Guidelines regarding lifecycle management
• Importance of Risk Probability Number (RPN) in QbD.
Who Should Participate?
This course is valuable for research scholars, industry personnel, R&D staff, QA staff and personnel engaged in marketing of pharmaceutical products to the developed countries. The course will be of immense value for the postgraduate and research scholar.
Registration
Applicants are required to send/deposit their duly signed registration form along with registration fees through cash/ cheque (in favor of Principal, Anand Pharmacy College, payable at Anand).
Registration charges:
Students/Research Scholar: Rs. 150
Academician : Rs. 200
Industry person: Rs. 300
Notes:
• Entry in seminar is limited to 150 participants.
• Registration fee covers day time hospitality during seminar and kit for the registered delegates.
• Registration fee is non-refundable.
• Last Date of Registration is 21/09/2018.
• The organizers reserve the right to change the published programme and course content as circumstances dictate.
Organized by;
ANAND PHARMACY COLLEGE
Managed by Shri Ramkrishna Seva Mandal
Opp. Town Hall, Anand, 388 001, Gujarat, INDIA
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