Live Webinar Capturing Justifications in Change Control, Risk Assessment, Validations, and Investigations

11:00 AM ET | 08:00 AM PDT | 10:00 AM CDT Duration 90 Minute

Webinar Includes : All the training handouts , Certificate ,Q/A and 90 Min Live Webinar

"Hear By 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."

undertake the planned investigation, change control, risk assessment or validation

Description

When there is a need to make some change to an environment and/or resolve a problem, we must think about a project that could implement the necessary change and address the problem. But we can’t just run our project without proper justification. Justifying the project is a great mechanism to confirm that our project really addresses the need and paves the way for improvement. It helps us assure interested parties or stakeholders that the project implements a particular solution to the problem and explains why this solution is best, as compared to other alternative solutions.
But how do we do a project justification? In this webinar, you will learn about analyses which are regarded as compliant and convenient ways to justify and confirm projects such as Change Controls, Risk Assessments, Validations, and Investigations.

Why You Should Attend:

As regulations change and become more stringent, one aspect of compliance has not changed, and that is ensuring changes, deviations, validations and risk assessments are done properly and have a proper justification and rationale.    It is easy to document what process has been performed, what has been investigated or changed or why something is a risk, but the difficult part is knowing how to explain or justify why it should be done or why a product should be released or rejected as a result.  In this webinar, you will learn efficient and complaint ways to justify the validations, changes or deviations in a manner that will explicitly demonstrate to the reader why the process was performed the way it was.

Areas Covered

•       How to propose a solution to the problem related to the deviation, change control, risk assessment or validation study
•       Determine alternatives or options to the proposed solution
•       Analyze costs, benefits, impacts, and risks of the proposed solution
•       Validate the solution, assess product impact to the market
•       Determine impact to the patient, system or firm as a result of your findings

Who will Benefit

•        Quality Assurance/Quality Control Directors, Managers, and Specialists 
•        Regulatory Affairs/Regulatory Compliance Directors, Managers, and Specialists 
•        Engineering/Development Directors, Managers, and Specialists

Industries who can attend

This 90-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.


Speaker Profile

Danielle DeLucy

Danielle DeLucy, MS, is currently an independent consultant to the biologics and pharmaceutical industries specializing in the areas of quality assurance and quality systems. Prior to this role, Ms. DeLucy 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.

Ms. DeLucy began her QA career as a quality control pharmaceutical microbiologist at Lancaster Laboratories, a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the quality management arena while increasing her responsibility. She has helped lead many regulatory health inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, she assists companies who are faced with warning letters and consent decrees establish more robust quality systems so that the company can succeed.

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