Managing SOP Compliance per FDA Regulations


Danielle DeLucy, MS, is Keynote speaker at ComplianceKey. She is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 15 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations. Danielle began her QA career as a Quality Control Pharmaceutical Microbiolo........

Overview

Standard Operating Procedures (SOPs) are a regulatory requirement for industries that are governed by the FDA and other world health authorities. Currently, there is no guidance on how to develop or manage the SOP creation or the SOP quality system.

Why should you attend this webinar?

Consequently, SOPs are frequently written in a way that makes compliance difficult or downright impossible. In many cases, this sometimes leads to subpar documents that come to light during a regulatory inspection. In this webinar you will learn how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is reproducible and easy to follow.

Areas Covered in the Session:

Why written procedures are beneficial
FDA expectations for written documents and Regulatory Requirements
Developing an effective review and approval process compliant with regulatory requirements.
How to implement a training program for document creation and review
A system for the control, archival, and disposal of written procedures.

Who can Benefit:



Webinar Id: LSHCDD004

Training Options:

Duration: 60 mins

 Stop, pause, and rewind: learn at your own place.

Ratings:
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 Recorded: [Six month unlimited access]

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

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