Equipment Qualification and Process Validation


Dr. Loren Gelber is a keynote speaker at ComplianceKey and she has more than 40 years in the pharmaceutical industry. She spent her first ten years at FDA, followed by 20 years in Regulatory Affairs and Compliance at various pharmaceutical companies, and the last ten years as a Regulatory Compliance Consultant. During this time she was a member of various groups and committees that worked on many compliance issues. She has published a number of papers and delivered various seminars and talks. Dr. Gelber holds a BA in Biology from Brandeis University, an MS in Chemistry from Brooklyn Polytechni........

Overview

FDA current Good Manufacturing Practice (GMP) regulations require that all equipment be qualified and all manufacturing processes, including equipment cleaning processes, be validated. These qualifications and validations must be repeated if changes are made or if problems are encountered, and periodically as necessary. FDA requirements for qualification and validation will be discussed.

Why should you attend this webinar?

Lack of adequate qualification or validation is a common FDA inspectional observation and FDA Warning Letter violation. Those involved in equipment qualification, including information technology (IT) and manufacturing and cleaning process validation will benefit from a review of the relevant FDA rules, written and unwritten. Those involved in hosting FDA inspections will also benefit.

Areas Covered in the Session:

Who can Benefit:




Webinar Id: LSHCLG0012

Training Options:

Duration: 60 mins

 01/30/2019

 12:30 PM PT | 03:30 PM ET

 Single Attendee: [Only for one participant]

$179 (Live)                    $319 (Live + Recorded)

 Multiple Attendee: [For a group of 2-5 participants]

$368 (Live)                    $495 (Live + Recorded)

 Corporate Attendee: [For a group of 6-10 Participants]

$741 (Live)                    $1157 (Live + Recorded)

 Recorded: [Six month unlimited access]

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

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