VIRTUAL
DATE
October 5–6, 2020
LOCATION
Virtual Training Platform
VIRTUAL
DATE
December 1–2, 2020
LOCATION
Virtual Training Platform
YOUR PARTICIPANT BENEFITS:
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Understand the elements of the and how each subsystem is interconnected to the rest in order to meet GMP requirements |
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Conduct internal audits to monitor quality and apply corrective actions when appropriate |
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Evaluate SOPs, design controls, and validation protocols from a quality perspective and make revisions or improvements as needed |
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Organize and manage evaluation data to improve product quality and address customer complaints |
ORGANIZATION BENEFITS:
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Operate a GMP compliant manufacturing operation that supports changes to facilities, equipment, and processes to support product improvement |
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Save money and ensure product quality by encouraging “quality by design” |
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Improve product safety and integrity through increased quality monitoring at all stages of the manufacturing process |
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Prepare for the FDA’s systems based inspection |
AFTER THIS TRAINING COURSE,
YOU WILL BE ABLE TO:
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Track and organize data efficiently to improve the evaluation process |
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Apply effective documentation techniques through the product life-cycle to avoid confusion and manage changes |
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Integrate risk assessment activities into the product design process to meet expectations of “quality by design” |
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Identify crucial training issues to address job-specific compliance responsibilities |
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Demonstrate a proactive approach to quality and improve operational efficiency |
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Anticipate and meet FDA expectations for a compliant quality system |
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Incorporate risk-management strategy to quality systems application |
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Build a quality-focused culture and facilitate management support for quality systems processes |
MEET THE INSTRUCTOR
JIM INGRAM
INGRAM CONSULTING SERVICES
Jim has over 20 years of management experience in manufacturing and packaging of pharmaceutical, food and cosmetic products, including over 10 years with GlaxoSmithKline. Throughout his career, he has had direct responsibility for compliance with government agencies such as FDA, EPA, DEA and DA. Over the past 15 years as an independent consultant, Jim has developed a range of processes and training programs, resulting in improved FDA audits and relief from Consent Decrees.
Jim received his Associates Degree in Engineering from Central Carolina Technical College and attended Campbell University Business School. He has numerous patents to his credit and is a Certified Packaging Professional with the Institute of Packaging Professionals.