The Role of Quality Assurance in the Pharmaceutical Industry

Duration 60 Mins
Level Basic & Intermediate
Webinar ID IQW19D0454

  • 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

Overview of the webinar

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

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

Why should you attend?

To understand Quality Assurance role in the 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

Faculty - Dr.Bernadette Alisantosa

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. 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.
 

For group or any booking support, contact: