2-days workshop on
Equipment Qualification and Validation of Processes
By: Joy McElroy
Coming soon.. Please contact customer care for new schedule at +1-510-857-5896
The FDA’s Quality System Regulation (QSR) is clear on the importance of equipment controls - you must have and follow procedures for installing, operating and maintaining all equipment used in your manufacturing processes. And that includes any ancillary equipment that affects production, such as environmental systems and contamination controls.
This training program will list the documents required for equipment qualification and process validation and discuss how to manage documents appropriately. Attendees will gain insight into best practices for writing and maintaining a Validation Master Plan (VMP). The course will also discuss best practices for writing and executing sound protocols for equipment qualification (IQ, OQ, PQ) and process validation.
Why Should you Attend
Participants will gain;
Regulatory Requirements and Expectations for Equipment Qualification
This training program will list the documents required for equipment qualification and process validation and discuss how to manage documents appropriately. Attendees will gain insight into best practices for writing and maintaining a Validation Master Plan (VMP). The course will also discuss best practices for writing and executing sound protocols for equipment qualification (IQ, OQ, PQ) and process validation.
Why Should you Attend
Participants will gain;
- An understanding of what the global expectations are for equipment qualification and validation
- An understanding of the documents required for equipment qualification and process validation and how to manage documents appropriately
- Understand and know how to write and maintain a Validation Master Plan
- Better writing and execution skills for sound protocols for equipment qualification (IQ, OQ, PQ) and process validation
- Ability to qualify already existing systems more effectively and efficiently and to execute requalification’s more effectively
- Ability to collect data, conduct tests, and obtain all necessary documents
- An understanding of the different types of validation
- An understanding of performance validation
- Knowledge of the guidelines on validating analytical methods and processes
- Ability to support equipment qualification and validation through the quality management system, risk analysis, calibration and maintenance, and change control
- An understanding and knowledge of the principles of auditing the equipment qualification and validation
- An understanding of external qualifications and validations from a contract manufacturer, and qualifications and validations by a supplier
- Ability to investigate true root causes of problems and to evaluate and prioritize solutions
- Ability to develop effective problem solving methods to help you asses which is best for your situation
- Ability to develop successful implementation plans
- Ability to perform risk assessments effectively
Regulatory Requirements and Expectations for Equipment Qualification
- Europe
- FDA
- Global harmonization and expectations
- Management of Documents, Documents Required
- Validation policy
- Validation Master Plan (VMP)
- Documents equipment qualification
- SOPs
- Responsibilities
- Validation team
- Presumption for qualification/validation
- Qualification phases, DQ, IQ, OQ, PQ
- Qualification of existing systems and equipment
- Requalification/validation
- SOPs
- Writing a qualification protocol, content
- Executing a qualification
- Tests and data
- Documents
- Writing a qualification final report
- Senior quality managers
- Quality professionals
- Regulatory professionals
- Compliance professionals
- Production supervisors
- Validation engineers
- Manufacturing engineers
- Production engineers
- Design engineers
- Process owners
- Quality engineers
Agenda
Day One:(8:30 a.m - 4:30 p.m)
(8:30 a.m. - 9:00 a.m.: Registration and Breakfast)
Speaker and Participant Introductions(9:00 a.m. - 9:15 a.m.)
Regulatory Requirements and Expectations for Equipment Qualification(9:15a.m. - 9:45a.m.)
General Aspects of Qualification(10:45a.m. - 11:00a.m.)
Qualification phases, DQ, IQ, OQ, PQ(11:00 a.m. - 12:00 p.m.)
Lunch and networking(12:00p.m. - 1:00p.m.)
Design Qualification (1:00 p.m. - 1:30 p.m.)
Installation Qualification(1:30 p.m. - 2:00 p.m.)
Operational Qualification(2:00 p.m. - 2:30 p.m.)
Process Qualification(2:30p.m. - 3:00p.m.)
Break/networking(3:00p.m. - 3:15p.m.)
Performance Qualification(3:15p.m. - 4:15p.m.)
Final questions/ Comments/Discussion(4:15p.m. - 4:30p.m.)
(8:30 a.m. - 9:00 a.m.: Registration and Breakfast)
Speaker and Participant Introductions(9:00 a.m. - 9:15 a.m.)
Regulatory Requirements and Expectations for Equipment Qualification(9:15a.m. - 9:45a.m.)
- Europe
- FDA
- Global harmonization and expectations
- Management of Documents, Documents Required
- Validation Master Plan (VMP)
- Documents equipment qualification
- SOPs
- Responsibilities
- Validation team
General Aspects of Qualification(10:45a.m. - 11:00a.m.)
Qualification phases, DQ, IQ, OQ, PQ(11:00 a.m. - 12:00 p.m.)
Lunch and networking(12:00p.m. - 1:00p.m.)
Design Qualification (1:00 p.m. - 1:30 p.m.)
Installation Qualification(1:30 p.m. - 2:00 p.m.)
Operational Qualification(2:00 p.m. - 2:30 p.m.)
Process Qualification(2:30p.m. - 3:00p.m.)
Break/networking(3:00p.m. - 3:15p.m.)
Performance Qualification(3:15p.m. - 4:15p.m.)
Final questions/ Comments/Discussion(4:15p.m. - 4:30p.m.)
Day Two:(8:30 a.m - 4:30 p.m)
(8:30 a.m. - 9:00 a.m.: Networking and Breakfast)
Operational Qualificationof existing systems and equipment(9:00a.m. - 10:00a.m.)
Performance Qualification and Process Validation(10:15a.m. - 11:15a.m.)
(11:15a.m. - 12:0p.m.)
Executing a qualification(1:00p.m. - 2:00p.m.)
Tests and data(2:00p.m. - 3:00p.m.)
(3:00pm - 3:15pm)Break and networking
Documents and writing a qualification report(3:15p.m. - 4:15p.m.)
Final questions/Comments/Discussion(4:15p.m. - 4:30p.m.)
(8:30 a.m. - 9:00 a.m.: Networking and Breakfast)
Operational Qualificationof existing systems and equipment(9:00a.m. - 10:00a.m.)
- Requalification/validation
Performance Qualification and Process Validation(10:15a.m. - 11:15a.m.)
(11:15a.m. - 12:0p.m.)
- Writing SOPs
- Writing a qualification protocol, content
Executing a qualification(1:00p.m. - 2:00p.m.)
Tests and data(2:00p.m. - 3:00p.m.)
(3:00pm - 3:15pm)Break and networking
Documents and writing a qualification report(3:15p.m. - 4:15p.m.)
Final questions/Comments/Discussion(4:15p.m. - 4:30p.m.)
Joy McElroy - Principle Consultant, Maynard Consulting Company
Upon earning a degree in Zoology from North Carolina State University, Joy McElroy made her debut in the pharmaceutical industry in 1992 at Pharmacia & UpJohn performing environmental monitoring and sterility testing. Her hard work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw their 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.
With over 20 years of total experience in the pharmaceutical and biotech industries, Ms. McElroy has gained extensive knowledge of quality assurance, process and cleaning validation, equipment qualification, sterilization, and GMP compliance auditing. Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries.
In 2013, Ms. McElroy started her own company, Maynard Consulting Company, which provides top engineers, auditors, and validation specialist to pharmaceutical, biotech and medical device clients across the United States, Canada, and the world.
With over 20 years of total experience in the pharmaceutical and biotech industries, Ms. McElroy has gained extensive knowledge of quality assurance, process and cleaning validation, equipment qualification, sterilization, and GMP compliance auditing. Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries.
In 2013, Ms. McElroy started her own company, Maynard Consulting Company, which provides top engineers, auditors, and validation specialist to pharmaceutical, biotech and medical device clients across the United States, Canada, and the world.