Strategies To Prevent Manufacture And Distribution Of Substandard Medications

Description:

Substandard product can exist even if the product itself is manufactured according to quality standards. Harm to patients and damage to a company’s reputation are the two most obvious consequences of substandard product. Yet, many companies pay too little attention to these problems, preferring short-term gain over long-term reputation and profitability. Within companies, it is common to hear the argument that quality is a cost center and does not directly contribute to the company’s profits. While the quality function is obviously not the same as sales and marketing, prevention of losses due to quality issues (e.g., product recalls) or remediation (e.g., addressing lawsuits or FDA enforcement actions) affects the bottom line every bit as much as sales. In this webinar we provide you with best practices that have been proven effective and equip you with the means to advocate for these ideas within your organization.

Why Should You Attend:

If a legitimate product is not manufactured according to quality standards or becomes degraded as it travels through its supply chain, it can be ineffective at best or deadly at worst. Examples of potential dangers that can occur include temperature excursions, inappropriate use, and unsafe ingredients inadvertently added to the product. In terms of effect, substandard pharmaceutical product is a worldwide issue on a par with counterfeiting.

Areas Covered in the Webinar:

• The problem
• Poisons
• Temperature excursions
• Risks to patients
• Risks to companies
• Solutions
• Maintain a robust quality system
• Supplier quality
• Product testing
• Monitoring temperature
• Join industry and governmental efforts to improve product quality worldwide
• Current initiatives
• Benefits to Pharma companies
• Explore new technologies to bolster product integrity
• Blockchain
• Portable testing devices
• Make a hardheaded assessment of risk and reward when assessing cost reduction initiatives
• Identify most vulnerable areas
• Cost-benefit considerations
• Review of learning objectives

Who Will Benefit:

Pharmaceutical industry, particularly those employees in the Supply Chain, including: Quality Assurance, Packaging and Labeling, Manufacturing, and Warehousing and Distribution.

Michael Esposito
Principal, TrainReach Consulting, LLC

Michael Esposito has 30 years’ experience in the pharmaceutical industry and 13 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 work plan for McNeil and revised their introductory GMP course. He is a member of the training organization GMP TEA and is fully fluent in Spanish. His areas of interest include systems training, training effectiveness, post-training user support, process improvement, and sustainable packaging.

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