Joy L McElroy
Principle Consultant, Maynard Consulting Company
Upon earning a degree in Zoology at North Carolina State University, Joy began working in the pharmaceutical and biotech industries in 1992 at Pharmacia & UpJohn performing Environmental Monitoring and Sterility Testing. Her work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw the Quality Control Lab. In 1998 Joy 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, Joy moved into Equipment Qualification and Cleaning Validation at Mallinckrodt.

With 19 years of experience as a consultant, and over 25 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Technical Writing, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualifications and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Biotest.

Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer, technical writer, and trainer in both the pharmaceutical and biotech industries. Joy specializes in Equipment Qualification, Cleaning Validation, and GMP Compliance Auditing, and technical writing.

In 2013 Joy started, Maynard Consulting Company, which provided engineers, auditors, and validation specialist to pharmaceutical, biotech and medical device clients across the United States.

In 2019 she opened her own company, McElroy Training and Consultancy, LLC which provides consultants for various projects as well as on and off site training to pharmaceutical and biotech companies throughout the United States, Canada, and the world.

Joy also spends her time mentoring and speaking as an Empowerment Speaker. Her goal is to empower people all over the world to live their dreams though implementing 5 simple techniques she has learned and applied through the years.
Upcoming Webinar
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.
Live Session Wednesday, 11 December 2019, 10:00 AM PDT | 01:00 PM EDT, Duration: 75 Minutes

Equipment Qualification and Process Validation
This equipment qualification and validation webinar will help you to understand the various processes of equipment qualifications (IQ, OQ & PQ) and process validation steps (when, what and how to test) in a manufacturing process. It will also highlight all the requirements of FDA cGMP regulations that all equipment to be qualified and all manufacturing processes be validated if problems are encountered changes have to make and periodically as necessary.
Live Session Monday, 16 December 2019, 12:00 PM PDT | 03:00 PM EDT, Duration: 90 Minutes

Recorded Webinar
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. Due to this guidance, you can be sure that your firm's quality agreement will receive increased scrutiny, leaving you vulnerable to the risk of non-compliant GMP products and services if your agreements aren't clear and enforced.
Recorded Session Get life time access for one participant with download option!

Writing Validation Master Plans: Best Practices for Authoring 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 guidelines for authoring a VMP and a team writing approach to authoring a Validation Master Plans will be discussed. Various types and examples of VMPs will be given and discussed. Participants will learn how to effectively write a VMP most appropriate for their manufacturing organization.
Recorded Session Get life time access for one participant with download option!

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.
Recorded Session Get life time access for one participant with download option!

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!

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.
Recorded Session Get life time access for one participant with download option!

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…
Recorded Session Get life time access for one participant with download option!

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.
Recorded Session Get life time access for one participant with download option!

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.
Recorded Session Get life time access for one participant with download option!

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.
Recorded Session Get life time access for one participant with download option!

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.
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.
Recorded Session Get life time access for one participant with download option!

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.
Recorded Session Get life time access for one participant with download option!

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.
Recorded Session Get life time access for one participant with download option!

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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