FDA Inspections: What Regulations Expect
Instructor:
Joy McElroy
Product ID: 705346
- Duration: 90 Min
Why Should You Attend:
In this 90 minute webinar attendees will gain an understanding of the parameters, approaches, and concerns of FDA inspectors, and the tools for preparing, coping, and managing those inspections in the pharmaceutical, biologics, and medical device facilities. Other objectives include inspection authorities and processes including 483s, warning letters, recalls, and other potential actions, inspection processes, use of mock audits required documentation, formats, archiving, as well as how to respond to inspection and audit results.
Areas Covered in the Webinar:
The Inspection Process
- Legal Issues
- Inspection Checklists
- Part 11 Signatures
- Archiving
- Audit Trails
- Mock Audits
- Documentation
- Report Writing
- Responding to FDA 483’s
Who Will Benefit:
- Quality Assurance Managers and Supervisors
- Validation Managers and Supervisors
- Engineering Managers and Supervisors
- Regulatory Affairs Managers and Supervisors
- Manufacturing and Operations Managers and Supervisors
- Laboratory Managers, Supervisors and Analysts
- IT Managers and Staff
- Consultants
- Senior Quality Managers
- Validation Engineers
- Manufacturing Engineers
- Production Engineers
- Design Engineers
- Process Owners
- Quality Engineers
- Quality Auditors
Joy McElroy
Principle Consultant, Maynard Consulting Company
Upon earning a degree in Zoology at 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 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.
More Training By Experts
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- Practicing Laboratory Safety in the Workplace
- Auditing and Qualifying Suppliers and Vendors - An Effective Risk Based Approach
- Best Practices for an Effective Cleaning Validation Program
- FDA Regulations for Environmental Monitoring (EM) Program
Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
