Quality Assurance: The Role of the Quality Assurance (QA) Professional in The Manufacture of Medical Products (ePub)

Quality Assurance: The Role of the Quality Assurance (QA) Professional in The Manufacture of Medical Products, presents an introduction to the role of the QA personnel in the biomedical industry, focused on the manufacture of pharmaceuticals and medical devices. The content is intended for those interested to work in the Industry and seek guidance about employment alternatives.

The book provides an introduction of the organizational structure and dynamics of working in a regulated manufacturing environment, under quality systems. In general, we present the important elements you need to know about the quality role in the industry. You will gain basic knowledge about quality, quality systems, quality audits, and how to handle non-compliance events.

You will also have an overview of the business and regulatory aspects of the sector.

The e-book content includes an introduction to the following topics:

Introduction to the Biomedical Industry
. Medical Devices and Products
. Pharmaceutical Industry
. Manufacturing

Quality
. Quality Assurance (QA)
. Quality Control
. Quality Unit
. Cost of Quality

Regulatory Environment
. Quality
. Quality Systems
. International Quality Standard: ISO
. Quality audits
. Regulatory Agencies
. Food and Drug Administration (FDA)
. What are GMP's?
. Why do we follow GMP?
. Inspection

Quality Systems Elements
. Design Control
. Materials Control
. Record Control
. Change Control
. Customer Complaints
. Process Performance

Documentation
. Procedures
. Records
. Good Documentation Practices

Quality Audits
. Responses to audits

Roles of the Quality Department
. Quality Assurance (QA)
. Operational Quality
. New Products
. Quality Control
. Laboratories
. Audits
. CAPA
. Documentation
. Training

Additional Roles
. Quality Assurance Professional (QA)
. QA versus QC
. Investigation
. Approval
. Product or Materials Disposition
. Audits
. Metrics and Trends
. Continuous improvement
. Failure investigation
. Training
. Document review

Skills and Knowledge

Conclusion