Elements of Quality Control and Quality Assurance; How to Create an Audit - Ready Quality Management System (QMS)

Location: Raleigh-Durham, NC,USA      Duration: 2 days

Date: August 16 - 17, 2018 from 830 AM - 430 PM edt

Presenter: Joy McElroy

The quality of a Pharmaceutical product has several definitions. Quality means the product is fit for its’ intended use, the product is free from defects, and the product meets or exceeds customer expectations.  The general public assumes manufactured pharmaceutical products are safe, efficacious, and have the correct identity.  The Quality Control and Quality Assurance units within our manufacturing facilities are responsible for ensuring pharmaceutical companies manufacture quality products. The questions become; What are the expected roles of Quality Control and Quality Assurance? How are these roles related? How are these roles different? What is the expectation from the FDA for these two entities? Finally, how is the perfect QMS created? This seminar will discuss these questions and provide pertinent information on how to create an audit ready QMS.

Areas Covered:                                       

  • FDA Expectations of Quality Control and Quality Assurance

  • Common FDA findings with Quality Control and Quality Assurance Departments

  • Requirements for a Sound Quality Management System

  • Applying GMP concepts to Quality Control and Quality Assurance

  • Implementing the QMS

Key Learning Objectives:

  • The FDA expectations for Quality Control and Quality Assurance

  • The role of Quality Control in your facility

  • The role of Quality Assurance in your facility

  • How to avoid receiving 483s for Quality Control and Quality Assurance issues

  • The requirements for a Sound QMS

  • How to implement and apply GMP concepts to your Quality Control and Quality Assurance roles

  • How to implement an effective audit ready QMS.

Who will be benefited?

  • Quality Control professionals

  • Quality Assurance professionals

  • Validation professionals

  • Management and Supervisory Personnel

  • Regulatory Personnel

 

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