Process Validation for Pharma and Biologics Industries


Joy L. McElroy is Keynote speaker at ComplianceKey. 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 ........

Overview

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 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.

Why should you attend this webinar?

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

Areas Covered in the Session:

Who can Benefit:



Webinar Id: LSHCJM002

Training Options:

Duration: 90 mins

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 Recorded: [Six month unlimited access]

 $167 (Single Attendee)  $599 (Unlimited Attendee)

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