This seminar will aim at understanding and scoping out various phases of
Qualification activities that will be integrated with the perspectives
of Instrument Control, System Suitability Test (SST), Analytical Methods
Validation and ensuring Data Integrity for Regulatory Compliance.
Why you should attend
is an area of growing concern, sometimes ridden with uncertainty as to
what needs to be done at each of stages of the Product Lifecycle. In
modern Pharmaceutical and Biotech laboratories, a composite array of
various gadgets, devices, analytical instruments and computerized
systems are used daily.
Who Will Benefit
- R&D Personnel
- Quality Assurance / Quality Control Staff
- Validation Managers
- Validation Coordinators
- Production and Process Development Personnel
- Regulatory/Compliance Managers
- Technicians Study Directors(GLP)
- Qualified Persons (EMEA)
- Pharmaceutical Development
- CRO Staff
- CRO Managers, Accredited Laboratories in general
- Any one engaged with Test Methods
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.
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.
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
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Time: 08:00 AM EDT | 11:00 AM PDT
- Quality Systems, Paradigm Shift, Global Perspectives
- QA/QC Validation
- Risk Assessment
- Measurement, Resolution, Errors, and Uncertainty
- Regulatory and QS Requirements
- The Product Life Cycle Concept
- USP chapter 1058
- Examples of Various Systems
- Strategies for Validation
- Documentation /Master Validation Plan
- Training Requirements
- Examples of Various Systems
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