Equipment Qualification and Validation of Processes
Joy McElroy entered the pharmaceutical industry in 1992 shortly after earning a Bachelor of Science degree at North Carolina State University. She began at Pharmacia & UpJohn performing environmental monitoring and sterility testing. From there she moved into a supervisory role at Abbott Laboratories where she oversaw the quality control lab. In 1998, Ms. McElroy moved to Wyeth Lederle and worked in quality assurance, performing GMP compliance audits, batch record reviews, and holding annual GMP training for new employees. After working in quality assurance for a few years, she moved into equipment qualification and cleaning validation at Mallinckrodt. She has worked all around the United States performing GMP compliance audits, writing and executing cleaning validations, equipment qualifications, and performing technical writing.
With over 30 years total experience in the pharmaceutical and biologics industries, Ms. McElroy has gained extensive knowledge of quality assurance, process and cleaning validation, environmental monitoring, equipment qualification, sterilization, GMP compliance auditing, and technical writing. Joy currently works for Actalent Services, LLC as the Validation Manager for sciences where she works with a team of highly qualified technical individuals to provide managed services to pharmaceutical, medical device and biologics companies around the world.
The course will examine best practices to provide thoughts and ideas to develop or improve the performance of your current system. This course will provide discussion on European and FDA regulations as well as global harmonization and expectations. The course will also cover specific aspects of equipment qualification and process validation, such as protocol writing, methodology and performance, report writing, and support.
Areas Covered
- Regulatory Requirements and Expectations for Equipment Qualification
o Europe
o FDA
- Global harmonization and expectations
- Management of Documents, Documents Required
o Validation policy
- Validation Master Plan (VMP)
- Documents equipment qualification
- SOPs
- Responsibilities
- Validation team
o Presumption for qualification/validation - General Aspects of Qualification
o Qualification phases, DQ, IQ, OQ, PQ
o Qualification of existing systems and equipment
o Requalification/validation - Performance Qualification
o SOPs
o Writing a qualification protocol, content
o Executing a qualification
o Tests and data
o Documents
o Writing a qualification final report - Questions
- Performance of a Process Validation
o SOPs
o Writing a process validation protocol
o Guidelines on Validating Analytical Methods
o Content and execution
o SOPs
o Writing the validation plan
o Methodology and performance
o Report writing for method validation
o Presumption for validation
o Support of Equipment Qualification and Process Validation
- Quality management system
- Risk analysis
- Calibration/maintenance
- Change control
- Auditing equipment qualification and process validation
Who Should Attend
- Senior quality managers
- Quality professionals
- Regulatory professionals
- Compliance professionals
- Production supervisors
- Validation engineers
- Manufacturing engineers
- Production engineers
- Design engineers
- Process owners
- Quality engineers
- Quality auditors
- Document control specialists
Why Should You Attend
In this webinar, participants will learn the different global agencies expectations of equipment qualification along with the development of a sound process validation program in order to develop and implement bulletproof solutions that are accepted, effective, and efficient.
Topic Background
Regulatory agencies have expectations that pharmaceutical, medical device, and biologics manufacturers will demonstrate control over their manufacturing processes. Therefore, equipment qualification and validation of processes is a critical component to consistently producing high-quality products.
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$200.00
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