2 Regions to choose from
February 17-18, 2020
LOCATION
Edison, NJ
TRAINING FACILITY
(COMING SOON)
HOTEL
TBD
DISCOUNTED ROOM RATE
TBD
TO MAKE RESERVATIONS
By phone: Call 714.750.8000
Online: Click Register Button Below
EAST
DATE
February 17-18, 2020
LOCATION
Edison, NJ
TRAINING FACILITY
(COMING SOON)
HOTEL
TBD
DISCOUNTED ROOM RATE
TBD
TO MAKE RESERVATIONS
By phone: Call 714.750.8000
Online: Click Register Button Below
WEST
DATE
COMING SOON
LOCATION
COMING SOON
HOTEL
INFO COMING SOON
DISCOUNTED ROOM RATE
INFO COMING SOON
TO MAKE RESERVATIONS
By phone: Call 732.692.1506
Online: Click Register Button Below
YOUR PARTICIPANT BENEFITS:
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Streamline and improve the process for managing customer complaints, recalls, field alerts and agency responses. |
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Gain knowledge of the processes and tools that can be used to improve your ability to manage and maintain and insure consistent compliance with agency requirements. |
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Improve your understanding of the impact that comes with complaints, recalls and field alerts and insure that risk of reoccurrence is less likely. |
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Learn ways to conduct internal improvement audits that will reduce the risk of issues that would result in future complaints, recalls and the need for field alerts. |
ORGANIZATION BENEFITS:
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Reduce the resources needed to manage and process complaints, recalls and field alerts. |
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Minimize the risk of major issues with product safety that would have an effect on complaints and recalls that could lead to field alerts or patient deaths. |
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Improve processing times to insure that response times show a since of urgency by the company and organization that will have a positive result on future audits and inspections. |
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Insure that there is better understanding and utilization of information gathered from complaints, recalls, audits and agency feedback that needs to be utilized during Annual Product Reviews. |
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.