Ms. Joy L. McElroy

Area Of Expertise : Clinical Diagnositics; Pharma and Drugs; Biotech
20 Years Of Experience
Training Industry : Life Sciences

Upon earning a degree in Zoology at North Carolina State University, I began working in the pharmaceutical industry in 1992 at Pharmacia & Upjohn performing Environmental Monitoring and Sterility Testing.  My work allowed me to move into a supervisory role at Abbott Laboratories where I oversaw the Quality Control Lab. In 1998 I moved to Wyeth Lederle and worked in Quality Assurance, performing GMP Compliance audits, batch record reviews, holding annual GMP training for new employees, and writing audit report, and SOPs. After working in Quality Assurance for a few years, I moved into Equipment Qualification and Cleaning Validation at Mallinckrodt.

With 12 years of experience as a consultant, and over 20 years total experience in the pharmaceutical and biotech industries, I have gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification, and Technical writing. I have written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Phillips Medisize. I also develop and deliver webinars, on-site training, and seminars for training in areas such as Technical Writing, Equipment Qualification, Cleaning Validations, FDA Audit Preparation and more.

In 2013 I started my 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. 

 

9 results Found
Live Webinar

Auditing and Qualifying Suppliers and Vendors - An Effective Risk Based Approach

The various regulatory agencies have expectations that suppliers and vendors will demonstrate control over their manufacturing processes, validations, and documentation. Quality auditing is the process of checking whether these organization ...

  • Basic & Intermediate & Advanced
  • 90 Mins
  • Jun 25, 2019
Recorded Webinar

Process Validation for Drugs and Biologics

This course will provide participants with a thorough understanding of the requirements of process validation for both small molecule (pharmaceuticals) and Biologic products. Attendees will learn how to establish an effective process valida ...

  • Basic & Intermediate & Advanced
  • 90 Mins
Recorded Webinar

Writing Validation Master Plans:Best Practices for Writing a Compliant Document

This webinar will discuss the major components of Validation Master Plans. It will discuss how the VMP is different from Validation SOPs. Various regulatory requirements for Validation Master Plans will be discussed as well as effective gu ...

  • Basic & Intermediate
  • 90 Mins
Recorded Webinar

Environmental Monitoring for Pharmaceutical Clean Rooms

This webinar will discuss various broad and critical aspects of an effective EM program such as the Phases of a cleanroom EM Program, Pre-Monitoring of a Cleanroom prior to Facility Validation, Facility Validation, Implementation of Routine ...

  • Basic & Intermediate & Advanced
  • 90 Mins
Recorded Webinar

Risk Based Approach to Auditing Quality Suppliers and Vendors

The various regulatory agencies have expectations that pharmaceutical manufacturers will demonstrate control over their manufacturing processes, validations, and documentation. Quality auditing is the process of checking whether these organ ...

  • Basic & Intermediate & Advanced
  • 90 Mins
Recorded Webinar

FDA Adverse Event Reporting

This training program will provide the regulatory requirements for complaint handling in the pharmaceutical & medical device industries. The course will touch on complaint sources and details will be furnished on the interrelationships ...

  • Basic & Intermediate & Advanced
  • 90 Mins
Recorded Webinar

Analytical Instrument and Equipment Qualification

Analytical instruments should be qualified and systems should be validated to demonstrate suitability for the intended use. This 90 minute webinar will provide attendees the regulatory background and guidance through the complete process from plan ...

  • Basic & Intermediate
  • 90 Mins
On-Demand Webinar

FDA Adverse Event Reporting

This training program will provide the regulatory requirements for complaint handling in the pharmaceutical & medical device industries.The course will touch on complaint sources and details will be furnished on the interrelationships regarding co ...

  • Basic & Intermediate
  • 90 Mins
Recorded Webinar

Environmental Monitoring (EM) Program

This 90-minute webinar will discuss various broad and critical aspects of an effective EM program such as the Phases of a cleanroom EM Program–Pre-Monitoring of a Cleanroom prior to Facility Validation, Facility Validation, Implementation of Routi ...

  • Basic
  • 90 Mins