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Speaker Profile
JOY MCELROY

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.


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$179.00
Orphan Drug History – Development and Overview

 Joy Mcelroy
 May 27 2020
 01 : 00 PM EST    
 90 Minutes
 Download Catalog
Orphan Drug History – Development and Overview

This webinar will discuss the history of Orphan drugs, and how the Orphan drug Act of 1983 has helped manufacturers move forward with developing and producing drugs for rare diseases and conditions.This webinar will discuss key issues with Orphan drugs such as clinical testing. Attendees will learn what the Orphan Drug Act is and how it has increased the manufacturer's willingness to develop and manufacture..

Showing 1 to 9 of 9 (1 Pages)
$200.00
Clinical Process Improvement

 Joy Mcelroy
 Recorded Webinar
 90 Minutes
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Clinical Process Improvement

Effective process improvement can be key to reducing delays and improving data accuracy. In clinical trials, turnaround time and data accuracy are critical. Likewise, the contract research organization (CRO) level or the institutional review board (IRB) level can have serious downstream effects, negatively impacting study efficacy and time-to-market. It is essential, therefore, that all participants in cl..

$200.00
Manufacturing Quality Agreements- Qualifying Suppliers and Managing Quality in FDA-Regulated Industries

 Joy Mcelroy
 Recorded Webinar
 90 Minutes
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Manufacturing Quality Agreements- Qualifying Suppliers and 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 finalize..

$200.00
Writing Validation Master Plans: Best Practices for Authoring a Compliant Document

 Joy Mcelroy
 Recorded Webinar
 90 Minutes
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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 dis..

$200.00
Writing and Enforcing Effective Standard Operating Procedures (SOP)

 Joy Mcelroy
 Recorded Webinar
 90 Minutes
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Writing and Enforcing Effective Standard Operating Procedures (SOP)

This course addresses how to write effective SOPs, and work instructions in support of your company's activities.Learning ObjectivesFood and Drug Administration (FDA), the International Organization for Standardization (ISO) requirements for documentationEffective written SOPs and work instructionsMandates for documentation set forth by the regulators, such as the Food and Drug Administration (FDA), the Int..

$200.00
Advanced Auditing Strategies to Detect and Mitigate Data Integrity Risks

 Joy Mcelroy
 Recorded Webinar
 90 Minutes
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Advanced Auditing Strategies to Detect and Mitigate Data Integrity Risks

Auditing is a critical aspect of an overall data integrity assurance plan. To successfully audit the integrity of data, auditors must possess specific knowledge, insights, and skills. A solid audit strategy and plan are critical to providing the highest degree of assurance that no data integrity breaches have occurred, short of 100% verification (which is unfeasible in an industry that generates large volum..

$200.00
Auditing Quality Suppliers and Vendors

 Joy Mcelroy
 Recorded Webinar
 90 Minutes
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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 organizations have implemented what they have stated in written procedures and whether their people are doing what the organizations procedures state they will do.Learning Obj..

$200.00
Effective and Practical use of FMEA for Risk-Based Approach to Computer Systems Validation

 Joy Mcelroy
 Recorded Webinar
 90 Minutes
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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 ..

$200.00
FDA Adverse Event Reporting

 Joy Mcelroy
 Recorded Webinar
 90 Minutes
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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 complaint handling and product recalls. The course will also include timeline requirements associated with adverse event reporting.   Areas Cover..

Showing 1 to 9 of 9 (1 Pages)