PharScite in Conjunction with CfPA Presents:
Pharmaceutical Technology Transfer and Regulatory Strategies
September 24-25, 2020, Muscat, Oman
This 2-day intensive, accredited course will provide a basic understanding of the technology transfer of analytical methods, active pharmaceutical ingredients, quality control standards, packaging components/operations and various pharmaceutical dosage forms from R&D to manufacturing. It is designed to provide an understanding of the issues affecting transfers within and outside a company. Topics will include transfers to/from international sites as well as to/from third parties. This course will also provide an overview of relevant FDA and ICH regulatory guidance documents including the Scale-up and Post Approval Changes (SUPAC) guidances documents and the Changes to an Approved NDA or ANDA Guidance. The issues affecting changes to the batch size, formulation, packaging components, site of manufacture, manufacturing process, analytical methods, specifications and processing equipment changes will be addressed. Speakers will use practical examples to highlight issues critical to successful technology transfer. Interactive case studies based on real examples will allow participants to develop strategies and plans in a team environment.
Who Should Attend
This course is intended for individuals from:
- Innovator, Generic, CMO, CRO and CDMO Companies
- Formulation and Process Development/Validation
- Regulatory Affairs, Quality Assurance
- Analytical Methods Development/Quality Control
- Package Development/Package Engineering
- Manufacturing and Technical Support
- Project Management and Operations Planning
Participants, as well as their managers, will benefit by gaining a better understanding of the complexities of technology transfer in the pharmaceutical industry. The course covers transfers of small molecule drug products; not biotechnology, vaccines or medical device products
Upon completion of this course, you will be able to:
- Utilize the interactive processes involved in technology transfer and describe the approaches used to transfer packaging components, analytical methods and a wide variety of dosage forms
- Describe the critical issues surrounding technology transfer and how to plan for success
- Classify post-approval changes according to their potential impact on product quality and performance
- Use relevant regulatory guidance documents to develop research and regulatory strategies
- List key issues in internal and third-party transfers
Mike Yelvigi is Principal and Managing Partner 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. Earlier to this, he was Head of Process Development and clinical supply group at Hoffman-La Roche Company, New Jersey. Other companies he has worked include Parke Davis (USA), G.D Searle and Organon Inc. He obtained his undergraduate degree in Pharmacy from Bombay University and graduate degree in Pharmacy, from Philadelphia College of Pharmacy.
He is an adjunct Assistant Professor of Pharmaceutics at the School of Pharmacy, University of Mississippi. He is an active member of AAPS, ISPE, AAiPS, FIP and has lectured at many symposiums in the pharmaceutical technology, drug development areas. 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 a editorial board member of Pharma Times journal.
Accreditations/Recertifications For This Course
The Center for Professional Advancement (CfPA) has been approved as an Accredited Provider by the International Association for Continuing Education and Training (IACET), 11130 Sunrise Valley Drive, Suite 350, Reston, VA 20190. In obtaining this approval, CfPA has demonstrated that it complies with the ANSI/IACET Standards which are widely recognized as standards of good practice internationally. CfPA is therefore authorized to offer IACET CEUs for its programs that qualify under the ANSI/IACET Standards. CEUs will be awarded for participation in CfPA’s courses at the rate of .1 CEU per contact hour upon successful completion of the entire course and 70% accuracy in the required Learners’ Assessment. This course offers a total of 12 contact hours, or 1.2 CEUs.