The Role of Quality Assurance in the Pharmaceutical Industry
Date : 29 January 2019
Time : 01 : 00 PM EST
Duration : 60 Minutes
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 working as the Attending Veterinarian for George Mason University in Fairfax, VA.
Her interests are focused on food-producing animals and their health related to human health and zoonoses impact on public health. She is the first and co-authors on several papers on scientific journals on Pathogenicity of environmental origin salmonella in specific pathogen-free and broiler chicks.
Dr. Alisantosa has been serving as a Veterinary reviewer for JoVE Scientific Video journal since 2010.
What is Quality Assurance (QA) in Pharmaceuticals?
Quality Assurance (Or Quality Management) is a wide-range concept covering all matters that individually or collectively influence the quality of a product. It is the totality of the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for their intended use (WHO). Quality Management, therefore, incorporate Good Manufacturing Practice.
To understand Quality Assurance role in Pharmaceutical Industry: which is to ensure:
- Raw materials used in the manufacturing are approved and procured from an approved vendor
- All data’s are recorded as per cGMP and is reviewed for accuracy and traceability
- Procedures are in place for performing the activities, operating and calibrating the equipment
- Quality is built up in the plant, process, and product. That a Robust Quality system is in place
- Training like induction, On the job, Scheduled and after any changes are conducted to respective individuals on time
- To prepare and approve Quality Policy, Quality Objectives, Quality Manual and Validation Master Plan
- Periodic Monitoring of the Quality Objectives
- Monitors all validation & stability activities are completed as per the schedule
- 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
- Preparation of Annual product quality reports, trending of data, determining product and process performance
- To arrange and conduct the self-inspection, identify gaps and take CAPA
- Review of related batch manufacturing records and QC testing data Prior to the release of any batch
Who Should Attend
- Study Directors
- Research Veterinarian/Clinical Veterinarian
- Quality Assurance Personnel
- Regulatory Compliance Personnel
- cGMP lab personnel and Facility Management
- Contract Research Organization (CRO) personnel
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
- Speaker: BERNADETTE ALISANTOSA
- Webinar Code: ALIS-0005