Assure compliance before an inspection,and prepare your organization for the future of regulation.
Within the Packaging and Labeling Quality Management System Training participants will receive a fresh view of new regulations, as well as standardized practices that need to be implemented in order to comply with FDA quality standards. Over the course of the two day training attendees will gain insight on a large scope of packaging and labeling topics including qualifications for personnel, control systems, records and documentation, monitoring devices and FDA expectations. The negative consequences of not being prepared for an FDA inspection can be extremely danger-ous and expensive. This course offers your organization the opportunity to feel secure in your packaging and labeling system, and will reformulate your processes to comply with the standards of a heavily regulated industry.
Reasons to Attend the Packaging and Labeling Training:
Learn best practices for implementing changes in packaging and labeling operations
Interact with instructor and attendees to assure system and regulation under standing
Define the components of a packaging and labeling system-based inspection
Establish maintenance standards for documentation and reporting
Determine validation standards
Mitigate risk by addressing compliance before inspection
Communicate, train and set qualifications for personnel
Assess development and manufacturing practices that will be targeted
Provide controls to assure no negative impact on your products quality
Understand current legislation and trends set by FDA regulations
Meet the Instructor:
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Jim Ingram
Ingram Consulting Services
Jim has over 20 years of management experience in the Manufacturing and Packaging of Pharmaceutical, Food and Cosmetic
Products (Including over10 years with GlaxoSmithKline). He has had direct responsibility for compliance with government
agencies such as FDA, EPA, DEA and DA throughout his career. Processes and training programs developed by Jim have resulted
in improved FDA audits and relief from Consent Decrees over the pass 9 years as an independent consultant.
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.
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Training Benefits Include:
Leverage risk with compliance to prepare yourself for the future of regulation
Establish packaging and labeling standards prior to inspection
Discuss SOP and GMP that will assure FDA compliance
Learn best practices and controls for your packaging and labeling system