Overview
Good Manufacturing Practices (GMP) describe the requirements for manufacturing drug products in a given country or region and cover areas such as facility design and sanitation, product testing, product identification, equipment, packaging, warehousing and distribution, and recordkeeping.
These requirements include the required education, training, and
experience for employees whose activities affect the quality of drug
products. Among those educational requirements is 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:
- Demonstrate 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
The
subject of introductory GMP includes a discussion of the pivotal events
that have shaped US laws on food, drugs, and cosmetics; the 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.
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 the US and the 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 manufacturing Packaging or Distribution of
Pharmaceutical products (e.g. Quality Assurance, Packaging, Operations,
Planning)
Speaker Profile
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.
Instructor
Michael Esposito
