How much does Successfully Investigating Deviations cost?

Registration options: Recording – 1 Viewer: $390; Recording – Unlimited Viewers: $1400.

Do I receive a certificate after completing Successfully Investigating Deviations?

Yes, a certificate of completion is included with your registration.

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Recorded WebinarNew

Successfully Investigating Deviations

Master the fundamental steps of deviation investigation — use objective evidence to determine root cause, develop effective CAPA, and avoid FDA 483 observations.

4.8(0 reviews)

1.5 hours

Instructor

Danielle DeLucy

Pharmaceutical Quality & Microbiology Consultant

Quantity

Recording – 1 Viewer

$390.00

Buy Now

Secure payment via Stripe

Certificate of completion

What You'll Learn

FDA and regulatory requirements for deviation investigations

Definitions and types of deviations and how to identify them

Conducting interviews — dos and don'ts during investigations

Using source documents and evidence to support root cause determination

Determining root cause and developing effective, sustainable CAPA

Key elements of the investigation report to avoid 483 observations

About This Event

This webinar will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA. The focus is on how to avoid the pitfalls that may occur during FDA inspections and help eliminate 483 observations. Topics include FDA and regulatory requirements for investigations, types of deviations, how to conduct interviews, using source documents and evidence, determining root cause, and writing effective CAPA to avoid 483 observations. Code: FDB2462

Curriculum

FDA Requirements and Types of Deviations

12 min

Conducting Investigations — Interviews and Evidence Collection

15 min

Root Cause Determination with Objective Evidence

12 min

Requirements

Deviation investigators, reviewers, and approvers in pharmaceutical or regulated industries
Applicable to QA, Regulatory Affairs, QC, and compliance auditors

Meet Your Instructor

Danielle DeLucy

Pharmaceutical Quality & Microbiology Consultant

Danielle DeLucy, MS, 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 Microbiologist at a contract laboratory where she performed various tests for clients. In the years after, she held positions in quality management while increasing her responsibility. She has helped lead many Regulatory Health Inspections and was instrumental in coaching peers prior to inspections. Currently, Danielle assists companies faced with warning letters, consent decrees and those wishing to improve compliance and establish more robust quality systems.

MS Microbiology15+ Years QA/QC LeadershipDirector of Product QualitySterility Assurance Expert

Quantity

Recording – 1 Viewer

$390.00

Buy Now

Secure payment via Stripe

Certificate of completion

Event Details

Format

Recorded Webinar

Duration

1.5 hours

Certificate

Included

Access

Lifetime

Topics

Deviations Investigation Root Cause CAPA FDA 483 GMP Pharmaceutical

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