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Specifications for APIs & Pharmaceutical Drug Products

 
  January 22, 2018  
     
 
CfPIE - The Center for Professional Innovation & Education, Malvern, PA USA
September 17 & 18, 2018


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

This active pharmaceutical ingredient (API) product compliance course will help the attendee to establish specifications meeting global regulatory requirements and expectations. Participants will also become effective in justification of specifications.

Why This Course Matters

Specifications 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 specification setting are (1) to determine appropriate and safe limits or quantitative ranges during clinical development and (2) to justify specifications for the product to enter the market. One of the most difficult challenges in establishing and subsequently justifying specifications is achieving the appropriate balance among all factors – patient safety and efficacy, scientific data, analytical variability, process knowledge and capability, regulatory requirements, and business issues.

The approach to specification setting and their justification has undergone significant change. Strategic international ICH regulatory guidances 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 approach to setting specifications 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 for the assigned specification 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?' Of equal importance is the need to justify which quality attributes do not need an assigned specification. Regulatory compliant deficiencies in assigned specifications have resulted in clinical holds and market approval delays.

Who Should Attend

This medical product compliance course is designed for those engaged in R&D, Regulatory Affairs, Quality Assurance and Quality Control who are responsible for activities in the development and manufacture of Active Pharmaceutical Ingredient (API) and Drug Products. Personnel who desire an in-depth knowledge of the critical role of specifications and the importance of USP compendial requirements, FDA regulations and ICH guidelines, as well as the relationship between ICH Guidelines and the Common Technical Document (CTD) will find this course of great value.

This comprehensive three-day course is also beneficial to R&D personnel responsible for the use of specifications in conducting Quality by Design (QbD) development of both API and Drug Products.

The course is also of interest to personnel in all departments who participate in the support of manufacture and release of APIs and Drug Products. This includes development personnel in preparing API and Drug Product under cGMP protocols for clinical and non-clinical use, as well as analytical chemists involved with stability testing, assays, methods development and drug release.

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

James Windham

Specialties: Regulatory

 

James Windham is owner of Windham Consulting LLC, which for the last 13 years has specialized in providing Quality Control and Quality Assurance cGMP documentation strategy for the pharmaceutical and medical device industry.

Jim has over 45 years of QC/QA experience and leadership in the pharmaceutical industry.  He has held technical staff and management positions at Warner-Lambert, Parke-Davis, and Pfizer.  He helped lead team efforts to bring processes and products from research and development to commercial production.  Some of the products are over-the-counter and prescription pharmaceutical now available in the U.S. and in Europe.

Jim has taught at several Central Pennsylvania liberal arts colleges, teaching Operations Management, Strategic Management, and International Business.

Jim obtained his B.S. in Biology/Chemistry from Shippensburg State University and his M.B.A. degree in Operations Management from Lebanon Valley College. 

 
Deadline for Abstracts: N/A
 
Registration: https://www.cfpie.com/ProductDetails.aspx?ProductID=204
E-mail: info@cfpie.com
 
 
   
 
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