Complying with FDA requirements for Deviation Investigations2019-10-29T20:21:24+00:00

2 Regions to choose from

DATE
February 6-7, 2020

LOCATION
San Francisco, CA

TRAINING FACILITY
MicroTek
655 Montgomery St. Suite 400
San Francisco, CA 94111

HOTEL
Hotel Zeppelin
545 Post Street
San Francisco, CA 94102

DISCOUNTED ROOM RATE
$240 – $319

TO MAKE RESERVATIONS
By phone: Call 415 563 0303
Online: Click Register Button Below
Cutoff date December 23rd

WEST

DATE
February 6-7, 2020

LOCATION
San Francisco, CA

TRAINING FACILITY
MicroTek
655 Montgomery St. Suite 400
San Francisco, CA 94111

HOTEL
TBD

DISCOUNTED ROOM RATE
TBD

TO MAKE RESERVATIONS
By phone: Call 714.750.8000
Online: Click Register Button Below

EAST

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:
Establish an investigation process flow that will insure consistency and thoroughness of the investigation and provide a better guidance document for remediation.
Provide a better understanding of how the components of the investigation work in conjunction with each other and the value that they provide. Such as: Root Cause Analysis,Corrective and Preventive Action, Interviews, Risk and Impact Assessments, Change Controls and Results Assessments.
Reduce the amount of time required by the Investigator in conducting the search for information needed in order to compile the investigation report./td>
Improve investigator confidence in the accuracy of the information being provided to determine the true root cause/causes of the deviation.
ORGANIZATION BENEFITS:
Improve timely processing and reduction of deviation investigation back logs and insure that
compliance requirements are being met.
Reduction of resources required for conducting deviation investigations and reduce
associated costs.
Insure that product safety requirements are consistently being met and that identified
deviations are not repeated.
Reduce the potential of violations associated with product/process deviations that might be
identified during agency inspections.
AFTER THIS TRAINING COURSE,
YOU WILL BE ABLE TO:
Track and organize data efficiently to improve the evaluation process
Apply effective documentation techniques through the product life-cycle to avoid confusion and manage changes
Integrate risk assessment activities into the product design process to meet expectations of “quality by design”
Identify crucial training issues to address job-specific compliance responsibilities
Demonstrate a proactive approach to quality and improve operational efficiency
Anticipate and meet FDA expectations for a compliant quality system
Incorporate risk-management strategy to quality systems application
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.