Packaging and Labeling in Pharmaceutical Production

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1 Packaging and Labeling in Pharmaceutical Production *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY! Seminar to help you understand compliant packaging and labeling process in the larger product development from conception of a product to its realization and distribution. Get equipped to reduce cycle time, avoid costly errors and delays, or product recalls. 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, r educe prices, deliver innovation, ensure patient compliance, and maintain business compliance. Packaging and Labeling activities are crucial. They should comply with regulatory agency requirements. They form a bridge between the conception of a product and its realization and distribution. Still, their importance is often underestimated, especially in the planning phases, which leads to unnecessary increases in cycle time, costly errors, and delays in product availability, or product recalls due to noncompliance. Understanding the packaging and labeling process in the larger product development process will provide you an advantage in achieving success. Learning Objectives: Articulate Packaging and Labeling s role in product development Ensure adherence to regulatory agency requirements Anticipate potential obstacles in marketing, medical affairs, regulatory, legal or quality assurance Work effectively with contract manufacturers or packagers Manage labeling in foreign languages Avoid unnecessary production costs, back orders and recalls, especially during product launches Seminar Fee Includes: Lunch AM-PM Tea/Coffee Seminar Material USB with seminar presentation Hard copy of presentation Attendance Certificate $100 Gift Cert for next seminar Areas Covered : Regulatory Agency Requirements SOPs and Change Control considerations related to packaging Packaging and Labeling Interactions Creation of the Package Codes Packaging Errors Labeling Errors Supply Chain Issues Special Considerations (e.g. product launches, clinical vs. commercial packaging)

2 Knowledge assessment Who will Benefit: Pharmaceutical industry, particularly those areas that develop packaging for the manufacturing of pharmaceutical products (Product Development, Production Planning, Manufacturing, Quality Assurance) This course will be of benefit to anyone who is a stakeholder in product launches, revisions to pharmaceutical labeling and packaging, or timely delivery of product, including Marketing Project Management Operations Regulatory Affairs Labeling and Packaging Quality Assurance Production Control Packaging Technology Labeling Coordination Package Engineers Packaging Operations Sales and Marketing Quality Assurance AGENDA Day 01(8:30 AM - 4:30 PM) 8:30-8:59 Registration Meet & Greet. 9:00 AM -10:00 AM: Seminar objectives review, expectations and scope. nterview attendees re their specific responsibilities and needs Agreement on focus 10:00 AM -11:00 AM: Regulatory requirements for packaging and labeling: FDA packaging regulations, FDA labeling regulations, FDA packaging regulatory requirements, FDA labeling regulatory requirements SOPs and Change Control considerations related to packaging: What commitments you make when you put your process in writing Consequences of noncompliance 11:00 AM -12:00 PM: Packaging and Labeling Interactions Packaging and Labeling workflows Review/knowledge check 12:00 PM -01:00 PM: Lunch 01:00 PM -02:00 PM: Creation of the Package: bill of materials, packaging component specifications, CAD drawings, materials, dimensions, folds, quiet areas, packaging line trials Unique identifiers (package, component numbers) 02:00 PM -03:00 PM: Codes - introduction Customer codes - types, positioning on components Company codes - types, positioning on components 03:00 PM -04:00 PM:

3 Verification of codes on packaging equipment Product security considerations 04:00 PM -04:30 PM: Knowledge check for day Day 02(8:30 AM - 4:30 PM) 8:30-8:59 Registration Meet & Greet. 9:00 AM -10:00 AM: Seminar objectives review, expectations and scope Review of Day 1 topics, feedback and conclusions 10:00 AM -11:00 AM: Labeling creation process Printed component types and considerations Serialization requirements Interaction with printers 11:00 AM -12:00 PM: Effects of Packaging and Labeling on: Production Warehousing and distribution Consumer use of product Knowledge check 12:00 PM -01:00 PM: Lunch 01:00 PM -02:00 PM: Packaging and Labeling errors Level of gravity of error depending on when it occurs Packaging and Labeling review of errors 02:00 PM -03:00 PM: Supply Chain issues Product launches Clinical vs. commercial packaging Role play for a product launch 03:00 PM -04:00 PM: Course review: overall impact of Packaging and Labeling in pharmaceutical production Questions and feedback 04:00 PM -04:30 PM: Knowledge assessment SPEAKER Michael Esposito Principal, TrainReach Consulting, LLC 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 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

4 Consent Decree workplan for Johnson & Johnson Consumer Healthcare 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, posttraining user support, process improvement, product security, and sustainable packaging. Please contact the event manager Marilyn ) below for: - Multiple participant discounts - Price quotations or visa invitation letters - Payment by alternate channels (PayPal, check, Western Union, wire transfers etc) - Event sponsorships NO REFUNDS ALLOWED ON REGISTRATIONS Service fees included in this listing Metricstream Inc- New York Events List JOA190514CEV