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.

Upcoming Webinar
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Recorded Webinar
Key Factors to Write an Effective Standard Operating Procedures (SOP) and Work Instructions (WI)
This course addresses how to write effective SOPs, and work instructions in support of your company's activities. This webinar is designed to outline the characteristic of an effective work instruction, and Standard operating procedure. The instructor will also help to differentiate Work Instructions from Standard operating procedures.
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Effective and Practical use of FMEA For Risk-Based Approach to Computer Systems Validation
Validation of computer systems is a regulatory requirement within the life sciences. "How much to validate" is one of the biggest challenges validation teams face. The struggle to balance time and available resources with compliance requirements often leads to insufficient testing and/or project overruns, which in turn can lead to significant regulatory and safety risks. One way to avoid these issues is to employ a common risk-prevention tool called Failure Mode and Effects Analysis (FMEA). FMEA will help you focus on your most significant risks, allowing you to more efficiently and effectively validate your computer systems.
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FDA Compliant QC and QA Practices: Creating a Perfect, Audit-Ready QMS
In the pharmaceutical world, the term "quality" has several definitions. Generally speaking, quality means the product is fit for its’ intended use, is free from defects, and 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. Within those functions, some common questions arise…
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Problem Solving - Root Cause Analysis in Pharma Manufacturing
This topic will touch on investigations whether they are post-Audit, Deviation related, Complaints, etc. It will transition into determination of RCA, the many tools used during RCA & what they really are and how to use them to greater effect.
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Writing Effective SOP’s for Quality Professionals: Best Practices for Life Science Companies
This training program will guide attendees in writing effective Standard Operating Procedures and Work Instructions. It will also discuss how to assess and write to the audience and how to review and revise SOPs and Work Instructions.
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QSR-Compliant Equipment Control & Validation of Processes in the Manufacturing Environment
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.
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FDA Regulations for Analytical Instrument Qualification and Validation Processes
In this webinar you will learn the different global agencies expectations of analytical 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. Through case study analysis we will examine best practices to provide thoughts and ideas to develop or improve the performance of your current system.
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Manufacturing Quality Agreements- Qualifying Suppliers & Managing Quality in FDA-Regulated Industries
Quality agreements are an integral part of outsourced GMP manufacturing and testing. They define the framework for quality expectations between you and your vendors and the responsibilities necessary to demonstrate drug quality, safety, and efficacy. In 2016, the FDA issued dozens of 483 observations relating to topics governed by the quality agreement system. Furthermore, in November 2016, the FDA finalized the "Contract Manufacturing Arrangements for Drugs: Quality Agreements Guidance for Industry" document.
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Understanding and Preventing Cleanroom Contamination: Gaining and Re- establishing Control of your Cleanroom
This webinar will focus on the critical steps in starting up a new cleanroom operation and releasing it for manufacturing. It includes a case study-based approach to dealing with excursion events and establishing control of the cleanroom after a worst case event.
Recorded Session Get life time access for one participant with download option!

Advanced Auditing Strategies to Detect and Mitigate Data Integrity Risks
Any successful records management plan will start with a benchmark assessment of your current state followed by a data integrity audit. This training program will teach attendees best practices on how to perform audits for data integrity within their organization. Attendees will also learn how to centralize management and eliminate silos.
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Auditing and Qualifying Suppliers and Vendors - An Effective Risk Based Approach
This 90-minute training program is designed for people tasked with performing external audits for their organizations. It is also for those tasked with developing, maintaining and/or improving programs for manufacturing facilities. This includes individuals that have quality management system responsibilities for making general improvements in their organization's performance specifically related to equipment, processes and documentation.
Recorded Session Get life time access for one participant with download option!

Total Organic Carbon Analysis for Cleaning Validation in Pharmaceutical Manufacturing
Total Organic Carbon (TOC) is a useful analytical method for cleaning validation studies, including design, qualification and routine monitoring. While there may be some confusion with the industry and regulatory bodies about the use of this analytical technique, it is widely used because of certain benefits. The basis of TOC as an analytical technique will be covered, involving the various technologies currently utilized. Cautions in sampling and analyses will be discussed, including the appropriate use of blank and controls.
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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 organizations have implemented what they have stated in written procedures and whether their people are doing what the organizations procedures state they will do.
Recorded Session Get life time access for one participant with download option!

Good Laboratory Practices (GLPs) - Comparing and Contrasting with Good Manufacturing Practices (GMPs)
Attend the webinar to get a proper contrast and comparison of GMP and Good Laboratory Practices (GLPs), CFR part 58, for conducting nonclinical laboratory studies that support applications for research or marketing permits for products such as food and color additives, human and animal drugs, medical devices for human use, biological products and electronic products that are regulated by the FDA.
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Gaining and Re-establishing Control of your Cleanroom
This webinar will focus on starting up a new cleanroom operation covering everything from utilities to environmental monitoring. The speaker will discuss about routine cleaning and disinfection, and how to address contamination and bring up the cleanroom after a worst case event. Cases studies on bringing up the site after a worst case event will be detailed and excursion investigations and troubleshooting parameters and suggestions will also be discussed.
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Equipment Qualification and Validation of Processes in the Manufacturing Environment
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.
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Technical Writing for the Pharmaceutical, Medical Device and Biotech Industries
This technical writing training program will offer attendees an understanding of how the reporting process supports products in research, development, and in the marketplace. This virtual session will highlight the mandates for documentation set forth by the regulators, such as the FDA, the ISO, and other governing bodies. The program will train attendees on effectively reviewing and revising documents and assessing your audience, in effect producing effective written correspondence.
Recorded Session Get life time access for one participant with download option!

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