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Validity : 25th Sep'23 to 05th Oct'23
Occupying a critical position in the success or failure of any pharmaceutical product launch or revision, Packaging and Labeling form a bridge between the conception of a product and its realization and distribution. Their activities are also crucial for compliance with regulatory agency requirements. The importance of Packaging and Labeling is often underestimated, especially in the planning phases of product and package development, which leads to unnecessary increases in cycle time, costly errors, and delays in product availability, or product recalls due to noncompliance. Many packaging and labeling errors are possible because the information that appears on each package comes from different sources and is subject to frequent changes, often in the middle of the packaging development process. The process thus requires diligence and attention to detail by packaging and labeling employees. These considerations become even more important during a product launch because of the criticality of meeting the launch date and the uncertainties surrounding regulatory agency approval or last-minute requests for changes.
After completing this course, you will be able to:
Pharmaceutical and life sciences companies are under an extreme amount of pressure to maintain an ever-increasing amount of regulation and legislation. With this pressure, they still need to increase efficiencies, bring new products to the market faster, reduce prices, deliver innovation, ensure patient compliance, and maintain business compliance. Understanding the packaging and labeling process in the larger product development process will provide you an advantage in achieving success because your knowledge of the processes and ability to articulate them to your colleagues will give you the leverage to resolve potential and actual roadblocks and enable you to advocate for attention to detail while respecting schedules.
Michael Esposito has over 30 years experience in the pharmaceutical industry and 17 years experience in GMP training and document management. He has worked for Wyeth Pharmaceuticals, Pfizer and Johnson & Johnson's McNeil Consumer Healthcare Division in a variety of areas including Packaging, project administration, Quality Assurance, Government Contracts, translations, systems training, and international operations. He collaborated in the development and implementation of the training portion of the Consent Decree workplan for McNeil and revised their introductory GMP course. He is a member of the training organizations GMP Training Educators Association and Association for GXP Excellence and is fully fluent in Spanish. His areas of interest include systems training, training effectiveness, post-training user support, process improvement, and sustainable packaging.