2019 - The Role of Quality Assurance in the Pharmaceutical Industry

Overview
This course is to emphasize the importance of QUALITY in pharmaceuticals:
The pharmaceutical environment today is changing quickly due to globalization, increased competition, cost constraint, demands for efficiency, development of international regulation, supply chain complexity, and product/process complexity. In this fast-changing environment, the people and companies that learn to adapt will prosper
To manufacture & deliver consistency zero-defect products to the patients
The quality, efficacy and safety attributes of products must be ensured so that the consumer health is not compromised
Areas Covered in the Session
What is Quality Assurance (QA) in Pharmaceuticals
Quality Policy, Quality Objectives, Quality Manual and Validation Master Plan
Periodic Monitoring of Quality Objectives
Ensures that all changes impacting the product and the established systems are documented and reviewed to analyze the impact
Ensures that all deviations, OOS/OOT & Market complaints are logged, investigated to identify the root cause so as to take CAPA to prevent recurrence
Review of related batch manufacturing records and QC testing data prior to release of any batch
Who Will Benefit
Study Directors
Research Veterinarian/Clinical Veterinarian
Quality Assurance Personnel
Regulatory Compliance Personnel
cGMP lab personnel and Facility Management
Contract Research Organization (CRO) Person
Speaker Profile
Dr. Bernadette Alisantosa obtained her MPVM degree from the University of CA, Davis, School of Veterinary Medicine in 1996. She is ACLAM Diplomate since 2009. Currently, she is currently a Consulting Veterinarian with Biomedical Research Consulting. Her interests are focused on food-producing animals and their health related to human health and zoonoses impact on public health.