Joy McElroy
Joy McElroy
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 and Computer System Validation and Part 11 Compliance. She has written and executed Equipment Qualifications and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Biotest, Novartis, Imprimis, Cody Laboratories, and Xceilence.
Her knowledge, experience, 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, and GMP, Audit Preparation, and SOP writing training, Computer System Validation and Part Compliance.
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.
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.
-
6-Hour Virtual Seminar on Qualification (IQ, OQ, PQ) and Validation of Laboratory Equipment and Systems for Regulated Industries
Pharmaceutical and Biotech laboratories use a multiple array of various gadgets, devices, analytical instruments and computerized systems on a daily basis. Qualification of equipment or ancillary systems are necessary to prove that all critical requirements work as intended and... -
3-Hour Virtual Seminar on Qualification (IQ, OQ, PQ) and Validation of Laboratory Equipment and Systems for Regulated Industries
Pharmaceutical and Biotech laboratories use a multiple array of various gadgets, devices, analytical instruments and computerized systems on a daily basis. Qualification of equipment or ancillary systems are necessary to prove that all critical requirements work as intended and... -
3-Hour Virtual Seminar on Ensuring Your Foreign Vendors are FDA Compliant – Conducting Vendor Audits, Monitoring, and Using Checklists
Vendor selection is a serious process. Manufacturers are responsible for compliance with their selected vendors. Any violations from the vendors can cause serious problems for the manufacturers. Choosing a foreign vendor is no different than choosing a domestic vendor.... -
Total Organic Carbon Analysis for Cleaning Validation in Pharmaceutical Manufacturing
One of the most useful analytical methods for cleaning validation studies is Total Organic Carbon (TOC). This includes the design, qualification and routine monitoring of the manufacturing process. While there does exist some confusion within the industry and regulatory... -
Auditing and Qualifying Suppliers and Vendors – An Effective Risk Based Approach
This 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... -
4-Hour Virtual Seminar on Good Laboratory Practices (GLPs) vs GMPs – Comparison and Contrasts
Nonclinical laboratory studies must comply with the Good Laboratory Practice (GLP) regulations prescribed in Title 21 CFR part 58. This has been crafted to ensure data quality and integrity. These studies support or are intended to support applications for... -
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... -
4-Hour Virtual Seminar on Analytical Instrument Qualification and Validation – Understanding Use of Excel and FDA Audit Preparation
Global agencies across the world have varied expectations of analytical equipment qualification which will be discussed in this webinar. You will also learn how to develop a sound process validation program in order to implement invulnerable solutions that are... -
FDA’s Adverse Event Reporting and Product Recalls
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 complaint handling and product recalls.... -
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 guidelines for authoring... -
Good Laboratory Practices (GLPs) vs GMPs – Comparisons and Contrasts
According to the FDA, CFR part 58, good laboratory practices (GLPs) are a set of guidelines for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products such as food... -
Establishing and Regaining Control of Cleanroom
This webinar will focus on starting up a new cleanroom operation covering everything from utilities to environmental monitoring. Routine cleaning and disinfection will also be addressed. Addressing contamination and bringing up the cleanroom after a worst case event will... -
3-Hour Virtual Seminar on Effective Cleaning Validation Procedures – Best Practices
This training program will be beneficial to personnel directly involved in the development of cleaning procedures, cleaning validation programs and plans. Additionally, those responsible for cleaning validation protocols and execution activities, including validation and laboratory personnel, as well as,... -
Sale!
-
Sale!
-
Sale!
-
Laboratory Safety – All You Need to Know
In this training program, attendees will gain an understanding of general laboratory safety and common lab operation procedures. The course will also instruct on what PPE to provide such as safety goggles, aprons, gloves, eyewash stations, fire extinguishers, first... -
Sale!
-
Sale!
-
3-Hours Virtual Seminar – Technical Writing for the Regulated 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... -
FDA Regulations for Analytical Instrument Qualification and Validation – Comprehensive Best Practices
The US Food and Drug Administration (FDA) expect that pharmaceutical manufacturers will demonstrate control over their manufacturing equipment. FDA’s findings of deficiencies concerning equipment validation indicate the agency expects definitive evidence that the equipment qualification and validation schedules of... -
FDA Regulations for Environmental Monitoring (EM) Program
Upon completion of this training, you will be able to Describe how Clean room Environmental Monitoring (EM) Program fits into the Regulations. Explain the basis of the Four (4) Phases of Clean room transitional monitoring (Pre-qualification through post-qualification EM)... -
How to Ensure Your Foreign Vendors are FDA Compliant – Conducting Vendor Audits, Monitoring, and Using Checklists
This webinar will give information on auditing foreign vendors for FDA compliance. It will discuss initiating audits, planning and preparing vendor audits, as well as, monitoring foreign vendor compliance. This webinar will provide FDA guidance on foreign vendor expectations,... -
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... -
Key Factors to Write an Effective Standard Operating Procedures (SOP) and Work Instructions (WI) – 4 Hour Virtual Seminar
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. This course... -
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... -
Process Validation Guidance Requirements, FDA, EU Annex 15, Qualification and Validation – 4 Hours Virtual Seminar
This training program will illustrate how these two different concepts are integrated (Phase 1, 2, and 3 vs. Stages 1, 2, and 3) and where do they merge. Attendees will learn if they exist independently of each other or... -
3-Hour Virtual Seminar on Validation and Part 11 Compliance of Computer Systems
This Computer System Validation Training course will explore proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Today, the FDA performs both GxP and Part 11 inspections, the Europeans have released an... -
Technical Writing for the Regulated 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... -
3-Hour Virtual Seminar on 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. They will learn how to establish an effective process validation system and integrate it with other... -
Sale!
-
Effective Cleaning Validation Procedures – Best Practices
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.... -
Sale!
Quality Control Laboratory Compliance – cGMPs and GLPs – 6 Hours Virtual Seminar
Good Laboratory Practices (GLPs), 21 CFR part 58 is a set of guidelines for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products such as food and color additives,... -
Computer System Validation and Part 11 Compliance
This webinar will discuss in detail the requirements of 21 CFR part 11 and updated European Annex 11 regulation including requirements for local, SaaS, and cloud hosting. It will also offer techniques to implement a computer system using risk-based...
