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Joy McElroy

Joy L. McElroy is Keynote speaker at Compliance Key. Upon earning a degree in Zoology at North Carolina State University, Joy made her debut in the pharmaceutical industry in 1992 at Pharmacia & UpJohn performing Environmental Monitoring and Sterility Testing. She then moved into a supervisory role at Abbott Laboratories where she oversaw their Quality Control Lab. From there she moved into auditing clinical and GMP laboratories, and manufacturing facilities, then into validation engineering.
Now with 14 years experience as a consultant, and over 20 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, Equipment Qualification, auditing, and GMP and GLP training. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, Phillips Medisize, Xcelience, and Novartis.
In 2013 Joy started her own company, Maynard Consulting Company, which provides consulting services to clients such as BioMerieux, Novartis, and Catalent.
Joy specializes in Equipment Qualification, Cleaning Validation, Sterilization, Environmental Monitoring, GMP Compliance Auditing, Good Documentation Practices, and GMP and GLP training.

 Webinar Id: LSHCJM0019
10:00 AM PT | 01:00 PM ET
 02/06/2019
 Duration 90 mins

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

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.


View Details

                $179
       Single Attendee
(Only for one Participant)
          $368
Multiple Attendee
( 2 - 5 Participants)
          $741
Corporate Attendee
( 6 - 10 Participants)
                   $167
         Recorded
(6 months unlimited access)
 Webinar Id: LSHCJM0020
10:00 AM PT | 01:00 PM ET
 03/20/2019
 Duration 90 mins

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 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 lear........


View Details

                $179
       Single Attendee
(Only for one Participant)
          $368
Multiple Attendee
( 2 - 5 Participants)
          $741
Corporate Attendee
( 6 - 10 Participants)
                   $167
         Recorded
(6 months unlimited access)
 Webinar Id: LSHCFJM003
 6 months unlimited
 Duration 90 mins
Ratings:
No reviews yet!!

FDA Inspections : What Regulations Expect

In this 90 minute webinar attendees will gain an understanding of the parameters, approaches, and concerns of FDA inspectors, and the tools for preparing, coping, and managing those inspections in the pharmaceutical, biologics, and med device facilities. Other objectives include inspection authorities and processes including 483s, warning letters, recalls, and other potential actions, inspection processes, use of mock audits required do........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCTJM001
 6 months unlimited
 Duration 90 mins
Ratings:
No reviews yet!!

Technical Writing for the Pharma, Biologics, and Medical Device Industry

This course addresses how to write effective correspondence ,reports, SOPs, and protocols in support of your company's activities.

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCJME003
 6 months unlimited
 Duration 90 mins
Ratings:
No reviews yet!!

Validation and Part 11 Compliance

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 updated Annex 11 regulation that expands Part 11 requirements and companies must update their systems and processes to maintain compliance. Many companies o........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCJM0001
 6 months unlimited
 Duration 90 mins
Ratings:
No reviews yet!!

FDA Inspections: What Regulations Expect

In this 90 minute webinar attendees will gain an understanding of the parameters, approaches, and concerns of FDA inspectors, and the tools for preparing, coping, and managing those inspections in the pharmaceutical, biologics, and med device facilities. Other objectives include inspection authorities and processes including 483s, warning letters, recalls, and other potential actions, inspection processes, use of mock audits required do........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCJM002
 6 months unlimited
 Duration 90 mins
Ratings:
No reviews yet!!

Process Validation for Pharma and Biologics Industries

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 systems such as Risk Management, Corrective and Preventive Action and Supplier Management. Participants will learn how to develop rigorous protocols and reports, as ........

$167 Recorded (6 months unlimited access)


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