These requirements include the required education, training and experience for employees whose activities affect the quality of drug products. Among those educational requirements are a course in Introductory GMP upon employment at a pharmaceutical company, and annual refresher GMP training. The goal of this webinar is to enable you to:
The subject of introductory GMP includes a discussion of the pivotal events that have shaped US laws on food, drugs and cosmetics; use of the terms GMP and cGMP (Current Good Manufacturing Practices); key sections in the US Code of Federal Regulations that impact drug manufacture; and how an organization can remain compliant with these regulations in their day-to-day operations.
- Demonstrate a basic knowledge of GMP requirements
- Interpret these requirements for your day-to-day operations
- Avoid the negative consequences of noncompliance
- Instill a culture of compliance in your organization
Why should you Attend
The laws that govern Good Manufacturing Practices (GMP) are a cornerstone of pharmaceutical production. Still, many companies fall short of the requirements that are written into US, UK, European and other laws, which can have disastrous consequences for patient health and a company's reputation, not to mention the resultant losses in revenue due to fines, declining sales and withdrawal of products from the market.
It is expected that all employees who are involved in pharmaceutical production will attend GMP-related training on a regular basis.
Areas Covered in the Session
- Food and drug oversight
- Pivotal events that shaped laws in US and scope of FDA actions
- GMP vs. cGMP
- Consequences of noncompliance
- Building a culture of compliance
- Emphasis on education and decision-making
- Training, memory retention, and accountability
- Avoiding over-reliance on metrics
Who Will Benefit
- This course will be of benefit to anyone whose responsibilities fall under the umbrella of manufacturingPackaging or Distribution of Pharmaceutical products (e.g. Quality Assurance, Packaging, Operations, Planning)
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 (AGXPE) and is fully fluent in Spanish. His areas of interest include systems training, training effectiveness, post-training user support, process improvement, and sustainable packaging.