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Validity : 13th Apr'24 to 23rd Apr'24
Process Validation for Drugs and Biologics
- Introduction to Process Validation
- Implementing a Process Validation System
- Process Validation Requirements
- Executing a Validation
- Supplier Process Validation
- Process Validation Lifecycle
- Process Validation Compliance
Overview of the webinar
This course will provide participants with a thorough understanding of the requirements of process validation for both small molecule (pharmaceuticals) and Biologic products. Attendees 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 well as create monitoring programs to ensure that defined critical parameters remain in control. The course will also review validation requirements for systems that generate electronic signatures and records as most new processes have this capability.
Who should attend?
- QA and QC managers
- Quality Engineers
- Validation managers
- Validation Engineers and Specialist
- Operations managers
- Regulatory compliance managers and personnel
Why should you attend?
One should attend this webinar to gain an understanding of .The new FDA perspective of a "Process Validation Life-Cycle" that starts at the Process Design phase (Process/Product Development) and continues through Process Qualification (Confirmation) and Continued Process Verification (Monitoring and Assessment of the process effectiveness) as stated by the FDA's new Guideline on Process Validation and its impact on how process validation activities are carried out. Participants will understand the perspective of the EMEA, ICH, WHO and PIC/S on process validation and how they can be incorporated into a single process validation system. Participants will be able to set up process validation programs and corresponding documentation including protocols and reports that meet current FDA, WHO, PIC/S and EU regulations. Finally participants will understand how to prepare and defend your own process validation approach/program and avoid costly delays and rejections by regulatory agencies.
Faculty - Ms.Joy L. 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.