2-days workshop on
Elements of Quality Control and Quality Assurance; How to Create an Audit - Ready Quality Management System (QMS)
Coming soon.. Please contact customer care for new schedule at +1-510-857-5896
Course Description
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.

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
Why Should you Attend
Participants will know what the FDA expects from Quality Control and from Quality Assurance. Participants will gain a thorough understanding of the differences between QC and QA and how they work together with management to develop the perfect Quality Management System. By attending this 2 day workshop, participants will gain knowledge of current FDA findings with Quality Control and Quality Assurance. They will also know the requirements for a Quality Management System. This workshop will also enable participants to apply GMP concepts to their own QC and QA units within their facility. They will be equipped with the understanding and knowledge to implement an audit ready QMS.

Who will Benefit
  • Quality Control professionals
  • Quality Assurance professionals
  • Validation professionals
  • Management and Supervisory Personnel
  • Regulatory Personnel
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.)

FDA Expectation for Quality Control and Quality Assurance((9:15a.m. – 9:45a.m.)
  • Differences between QC and QA
  • How QC and QA work together to create a QMS
  • Role of Management
The different roles of QC and QA in the manufacturing facility(9:45a.m. – 10:30a.m.)

Break/networking(10:30a.m. – 10:45a.m.)

Common FDA findings from Quality Control and Quality Assurance(10:45a.m. – 12:00p.m.)

Lunch and networking(12:00p.m. – 1:00p.m.)

Avoid receiving 483s and warning letters for QC and QA issues(1:00 p.m. - 2:00 p.m.)

Requirements for a sound Quality Management System(2:00p.m. – 3:00p.m.)
  • Manufacturing
  • Management
Break/networking(3:00p.m. – 3:15p.m.)

Requirements for a sound Quality Management System cont'd(3:15p.m. – 4:15p.m.)
  • SOPs
  • Resources
  • Personnel Development
  • Training
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)

Implementing and applying GMP concepts to your Quality Control Unit(9:00a.m. – 10:00a.m.)

(10:00a.m. – 10:15a.m.)Break

Implementing and applying GMP concepts to your Quality Assurance Unit(10:15a.m. – 11:15a.m.)

Tying QC, QA, Manufacturing, and Management together for a sound QMS(11:15a.m. – 12:00p.m.)

(12:00p.m.– 1:00p.m.)Lunch

Implementing an effective Internal Audit System(1:00p.m. – 3:00p.m.)
  • SOPs
  • Frequency of Audits
  • Audit Conduct
  • Internal Audit observations
  • Mock FDA Audits
(3:00pm – 3:15pm)Break and networking

Implementing an Audit Ready QMS(3:15p.m. – 4:15p.m.)
  • Change Control
  • Analyzing Data Trends
  • Trending
  • CAPAs
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.