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Implementing Good Manufacturing Practices for API

  January 15, 2020  
CfPA-The Center for Professional Advancement, Amsterdam, The Netherlands
11-12 May 2020

Who Should Attend?
All pharmaceutical personnel who have responsibility for ensuring compliance for the manufacture, processing, packing, or holding of Active Pharmaceutical Ingredients will benefit greatly by attending. In addition, the training will address the needs of those senior level managers, directors and C suite executives who have management responsibility for complying with Good Manufacturing Practices to provide support, resources and implementation for the development, manufacturing and quality of APIs.

Course Description
The course is intended to provide practical examples and solutions on how the requirements and recommendations from the ICH Q7 guide can be met. Based on the ICH Q7 Guide, this course may serve as introductory training as well as a refresher for continuous training for API manufacturers. The course is designed for a comprehensive understanding of the key elements of GMP that are applied to the manufacturing of API. Examples of investigations, complaints, deviations, mock audit and considerations for building a quality culture are provided.

This 2 day accredited training will provide a comprehensive strategy for implementing key Current Good Manufacturing Practices (CGMPs) to Active Pharmaceutical Ingredients (APIs) lifecycle. Attendees will become familiar with a corporate management team and quality unit responsibilities. Attendees will be able to develop and implement a Quality Risk Management (QRM) policy, perform Root Cause Analysis (RCA) in the investigation of manufacturing nonconformance, Out Of Specification (OOS) test results and customer complaints. Following this course, you will be able to create and apply an auditing and inspection system to maintain compliance and create opportunities for continuous improvement. In addition, participants are encouraged to bring their questions and challenges to be included in the examples and discussions.

Organized by: CfPA-The Center for Professional Advancement
Invited Speakers:
   Gary Ritchie, Consultant to the pharmaceutical industry

Gary Ritchie is a dynamic pharmaceutical scientist with strong communication and leadership skills, and a proven track record of helping clients across a wide range of practice areas craft and execute strategies in pharmaceutical analysis, quality improvement and align and improve laboratory operations, customize and implement enabling technologies, and affect organizational change. He specializes in pharmaceutical analysis, quality and regulatory compliance, project and personnel management, research and development, facilitation, communications, and training.

He was Director of Operations and Regulatory Affairs Analyst at Dynalabs where he led the firm’s laboratory, sample management operations and regulatory strategy. Prior to that, he was a Director of Scientific Affairs with Infratrac, a woman-owned start-up company, where he developed anti-counterfeiting solutions for multiple industries culminating in several patents for 3D printing technologies. Mr. Ritchie was Scientific Fellow for Process Analytical Technology (PAT) and Liaison for the United States Pharmacopeia general chapters, pharmaceutical waters and statistics expert committees.

Mr. Ritchie graduated from the University of Bridgeport. Mr. Ritchie is recognized as a subject matter expert in multivariate analysis of spectroscopic data, having been an invited speaker to multiple national and international symposia, most notably the Royal Society of Chemistry He was a Chairman of the ASTMI Committee E13 on Molecular Spectroscopy and Separation Science, Chairman of the International Diffuse Reflectance Conference and President of The Council For Near-Infrared Spectroscopy.
Deadline for Abstracts: N/A
Registration: Please click here for registration information.
E-mail: Jmorbit@cfpa.com
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