home   genetic news   bioinformatics   biotechnology   literature   journals   ethics   positions   events   sitemap
  HUM-MOLGEN -> Events -> Courses and Workshops  

Pharmaceutical Semi-Solid Dosage Form: Development, Manufacture & Scale-up

  July 08, 2014  
CfPA-The Center for Professional Advancement, Amsterdam, The Netherlands
17-18 November 2014

Who Should Attend
The course is designed for individuals engaged in the pharmaceutical Semi-Solid dosage forms. It is intended for individuals who work in formulation development, raw materials selection, drug delivery systems, scale-up and manufacturing process, validation, clinical supply manufacture and quality testing. Such personnel include:

  • Semi-solid Formulation Scientists
  • Manufacturing supervisors/Engineers/Managers
  • Manufacturing Operators/Technicians
  • Pilot Plant Operation and Scale-Up
  • Regulatory Affairs/Quality Control
  • CMC Project/Technology Transfer Staff
  • Project Managers/Business Development
  • R&D scientists/Technicians

This intensive, 2-day course will provide a set of theoretical and practical tools for pharmaceutical semi-solid formulation development either for prescription or OTC drugs. The selection of the correct raw materials and manufacturing processes needed to create stable semi-solid dispersed phase products and to effectively solve problems arising during development will be addressed. Troubleshooting existing commercial product problems will be emphasized. Emulsion and suspension behavior will be described along with current methods to analyze the behavior of dispersed phases and methods to measure and predict stability. Processing and scale-up issues specific to the type of equipment will be covered. Key emphasis will be placed on application of recent Quality by Design (QbD) principles and Process Analytical Technology (PAT). Risk analysis tools, key principles of process validation, technology transfers and clinical manufacturing will be discussed.

Organized by: CfPA-The Center for Professional Advancement
Invited Speakers: Mukund "Mike" Yelvigi; Founder and Principal, Center for Pharmaceutical Integration, LLC. New Jersey

Mike Yelvigi is founder & principal at Center for Pharmaceutical Integration LLC, which provides consultation service to the industry in the area of CMC support &Technology Integration and Transfers (mergers & acquisitions). He retired as Sr. Director and Head of CMC Therapeutic Area Management function at Pfizer/Wyeth Inc. NY. He had responsibility for co-ordination of CMC activities related to drug substance synthesis, drug product formulation, analytical development and regulatory filing for several therapeutic areas. He has over thirty years extensive experience in pharmaceutical formulation, process development/scale-up, process validation, manufacturing and pre-approval inspections and has successfully launched several products globally. He obtained his undergraduate degree in Pharmacy from Bombay University and graduate degree from Philadelphia College of Pharmacy.

He is an adjunct Assistant Professor of Pharmaceutics at the School of Pharmacy, University of Mississippi and an active member of AAPS, ISPE, AAiPS, FIP. He was the Chairperson of the AAPS Manufacturing Science & Engineering section and is also an Executive committee member of the Industrial Pharmacy Section of FIP. He is an editorial board member of Pharma Times journal.

Khurshid Iqbal, Ph.D.; Pharmaceutical & Biotechnology Consultant and Advisor

Khurshid Iqbal, Ph.D. has over 25 + years of domestic and international experience in pharmaceutical product development. He has worked within the leading multinational pharmaceutical organizations, R.W. Johnson Pharmaceutical Research Institute, Hoffmann-La Roche and E.R. Squibb & Sons and last as Sr. Vice President and CSO at KBI Biopharma, Inc. Dr. Iqbal earned his Ph.D. in Pharmaceutics from The University of Sciences, Philadelphia and has remained active in the field of biopharmaceutical formulation development, drug delivery and stabilization of proteins and peptides. He has served as the section chair of the Biotech section of The American Association of Pharmaceutical Scientists, (AAPS) and has remained active with the growth of this organization.
Deadline for Abstracts: n/a
Registration: Please click here for registration information.
E-mail: sberg@cfpa.com
home   genetic news   bioinformatics   biotechnology   literature   journals   ethics   positions   events   sitemap

Generated by meetings and positions 5.0 by Kai Garlipp
WWW: Kai Garlipp, Frank S. Zollmann.
7.0 © 1995- HUM-MOLGEN. All rights reserved. Liability, Copyright and Imprint.