ComplianceOnline

Expert Profile


Joy McElroy
Principle Consultant, Maynard Consulting Company

Joy McElroy entered the pharmaceutical industry in 1992 shortly after earning a Bachelor of Science degree at North Carolina State University. She began at Pharmacia & UpJohn performing environmental monitoring and sterility testing. From there she moved into a supervisory role at Abbott Laboratories where she oversaw the 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. She has worked all around the United States performing GMP compliance audits, writing and executing cleaning validations, equipment qualifications, and performing technical writing.

With over 30 years total experience in the pharmaceutical and biologics industries, Ms. McElroy has gained extensive knowledge of quality assurance, process and cleaning validation, environmental monitoring, equipment qualification, sterilization, GMP compliance auditing, and technical writing. Joy currently works for Actalent Services, LLC as the Validation Manager for sciences where she works with a team of highly qualified technical individuals to provide managed services to pharmaceutical, medical device and biologics companies around the world.

Trainings by Expert

Good Laboratory Practices (GLPs) - Comparing and Contrasting with Good Manufacturing Practices (GMPs)
Category: Drugs and Chemicals (Pharma) , Biotechnology , Laboratory Compliance , All FDA Regulated Industry , FDA Audit and Inspection , FDA Validation , Testing and Validation , Quality and Safety , Audits & Inspections , Laboratory , Drug Development , Quality & Safety , Drugs Regulations , Biotech Regulations , Audit & Inspection-Role , Internal Audit , Lab Audit , Drugs Inspections , Life sciences QA/QC , Research & Development , Drug R & D , Regulations & Guidances , Life Sciences , Regulatory Affairs , QA/QC

Practicing Laboratory Safety in the Workplace
Category: Drugs and Chemicals (Pharma) , Laboratory Compliance , HR Compliance , OSHA Compliance , Quality and Safety , GLP & Other Best practices , Regulatory Requirements , Workplace Safety , Health and Safety , Audit & Inspection-Role , Lab Audit , Documentation and Policy Management , Lifescience process & Procedures , Life sciences QA/QC , Regulations & Guidances , Regulatory Affairs , Documentation and Data Management , QA/QC , EH&S, Green Compliance

Auditing and Qualifying Suppliers and Vendors - An Effective Risk Based Approach
Category: Drugs and Chemicals (Pharma) , Medical Devices , Clinical Research , Biotechnology , All FDA Regulated Industry , FDA Validation , Testing and Validation , Quality and Safety , Audits & Inspections , QMS, ISO 13485, CAPA , Supply Chain and Manufacturing , Laboratory , Quality & Safety , Drugs Regulations , Clinical Trial Regulations , Biotech Regulations , Audit & Inspection-Role , Medical Device Inspection , Lab Audit , Drugs Inspections , Clinical Research Audit , Documentation and Policy Management , Lifescience process & Procedures , Life sciences QA/QC , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management , QA/QC

Best Practices for an Effective Cleaning Validation Program
Category: Drugs and Chemicals (Pharma) , All FDA Regulated Industry , FDA Audit and Inspection , GXP Pharmaceutical , FDA Validation , Testing and Validation , Quality and Safety , Audits & Inspections , Laboratory , Audit & Inspection-Role , All FDA Reg. based Audit , Life sciences QA/QC , Regulations & Guidances , Best Practices & GXPs , Life Sciences , QA/QC

FDA Regulations for Environmental Monitoring (EM) Program
Category: Drugs and Chemicals (Pharma) , Medical Devices , Clinical Research , Biotechnology , Laboratory Compliance , All FDA Regulated Industry , Quality Management , GXP Pharmaceutical , GXP Medical Devices , Quality and Safety , Supply Chain and Manufacturing , R & D , Laboratory , Contamination Control , Quality & Safety , Best practices , Audits, CAPA , Drugs Regulations , Clinical Trial Regulations , Biotech Regulations , Risk Management & Controls , All FDA Regulated Functions , Audit & Inspection-Role , Quality Audit , All FDA Reg. based Audit , Medical Device Inspection , Lab Audit , Drugs Inspections , Clinical Research Audit , Documentation and Policy Management , Lifescience process & Procedures , Manufacturing Quality , Quality management tools , Life sciences QA/QC , Research & Development , Drug R & D , Device R & D , Supply chain & Procurement , Regulations & Guidances , Best Practices & GXPs , Life Sciences , Regulatory Affairs , Common FDA Regulations , QA/QC

Equipment Qualification Basics
Category: Drugs and Chemicals (Pharma) , GXP Pharmaceutical , Drug and Device Approvals , FDA Validation , Documentation and IT , Quality and Safety , Crisis Management , Drug Development , Drugs Regulations , Risk Management & Controls , All FDA Regulated Functions , Audit & Inspection-Role , Drugs Inspections , Research & Development , Drug R & D , Regulations & Guidances , Best Practices & GXPs , Life Sciences , Regulatory Affairs , Documentation and Data Management , Common FDA Regulations

Technical Writing for the Pharmaceutical, Medical Device and Biotech Industries
Category: Drugs and Chemicals (Pharma) , Medical Devices , Biotechnology , All FDA Regulated Industry , GXP Pharmaceutical , GXP Medical Devices , Documentation and IT , Quality and Safety , QMS, ISO 13485, CAPA , Quality & Safety , Technologies and Processes , Drugs Regulations , Biotech Regulations , Risk Management & Controls , All FDA Regulated Functions , Life sciences QA/QC , Research & Development , Drug R & D , Device R & D , Regulations & Guidances , Life Sciences , Regulatory Affairs , Common FDA Regulations , QA/QC

4-Hr Virtual Training: How to Respond to an FDA Investigation
Category: Drugs and Chemicals (Pharma) , Medical Devices , Biotechnology , All FDA Regulated Industry , All FDA Regulated Industry , FDA Audit and Inspection , GXP Pharmaceutical , GXP Medical Devices , Documentation and IT , Quality and Safety , Audits & Inspections , QMS, ISO 13485, CAPA , Supply Chain and Manufacturing , Quality & Safety , Risk Management & Controls , All FDA Regulated Functions , Audit & Inspection-Role , All FDA Reg. based Audit , Documentation and Policy Management , Lifescience process & Procedures , Life sciences QA/QC , Regulations & Guidances , Best Practices & GXPs , Life Sciences , Documentation and Data Management , QA/QC

Process Validation Guidance Requirements, FDA, EU Annex 15; Qualification and Validation
Category: Drugs and Chemicals (Pharma) , Medical Devices , Biotechnology , All FDA Regulated Industry , FDA Audit and Inspection , GXP Pharmaceutical , GXP Medical Devices , FDA Validation , Testing and Validation , Quality and Safety , Audits & Inspections , QMS, ISO 13485, CAPA , Supply Chain and Manufacturing , Quality & Safety , Technologies and Processes , Drugs Regulations , Biotech Regulations , Audit & Inspection-Role , All FDA Reg. based Audit , Life sciences QA/QC , Regulations & Guidances , Best Practices & GXPs , Life Sciences , Regulatory Affairs , Documentation and Data Management , Common FDA Regulations , QA/QC

4-Hr Virtual Training: Key Factors to Write an Effective Standard Operating Procedure and Work Instructions
Category: Drugs and Chemicals (Pharma) , Medical Devices , Biotechnology , All FDA Regulated Industry , GXP Pharmaceutical , GXP Medical Devices , Documentation and IT , Quality and Safety , QMS, ISO 13485, CAPA , Supply Chain and Manufacturing , R & D , Drug Development , Quality & Safety , Technologies and Processes , Drugs Regulations , Biotech Regulations , Life sciences QA/QC , Research & Development , Drug R & D , Device R & D , Regulations & Guidances , Life Sciences , Regulatory Affairs , Common FDA Regulations , QA/QC