Live Webinar Implementing a Change Control Quality System Successfully

01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Webinar Includes : All the training handouts , certificate by the speaker ,Q/A and 60 mins 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."

Description

This 60-minute accredited online training course will help attendees understand the fundamental change control steps and processes. It will focus on change proposals, assessments, execution and final implementation. The importance of proper planning, critical thinking skills, and coordination of all change activities will also be discussed.

Who Should Attend?

This online training course is intended for all Pharmaceutical professionals involved in the manufacture of drugs and drug products. It will be beneficial for all levels of management along with quality professionals.

Areas Covered

Course Outline

• Overview of Change Control Regulatory Requirements
o What is Change Control?/Why Change Control?
o Types of Changes Subject to Change Control
o Like for Like
o Specification changes
o Facility Changes
o Equipment Changes
o Emergency Changes
• Change Control Proposal
o Proper documentation
o Elements to be included
• Change Assessment (Risk, Impact) and Approval to Execute
o Impact to products
o Impact to facility
o Impact to Regulatory Filings
o Change Control Board Development
o Areas of Responsibilities for Board Members
o Establishing Action Items
o Establishing Deadlines
o Final Implementation of Change
• How to close out a change
o Effectiveness of the change
o Change Control Documentation
• Hard copy systems
• Electronic systems

Who will Benefit

Pharmaceutical professionals involved in the manufacture of products
All levels of management
Quality professionals

Industries who can attend

This online training course is intended for all Pharmaceutical professionals involved in the manufacture of drugs and drug products. It will be beneficial for all levels of management along with quality professionals


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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