3-Hour Certification Course on Good Manufacturing Practices (GMP) – An Introduction

Good Manufacturing Practices (GMP) are a cornerstone of life sciences production. In fact, this decades-old regulation is so important that nearly everyone from discovery through product production should have a working knowledge of it. Despite this, even those directly responsible for GMP compliance fall short of the requirements that are written into law for the US, Europe and other markets, which can have disastrous consequences for patient health and lost revenues.

If you work in a GMP-related environment, or work with those who do, this 3-Hour primer is a perfect way to introduce yourself to manufacturing in the life sciences. Many regulatory bodies observe a certification course on GMP as a mandatory activity every year. This program includes successful completion of post-course assessment and evaluation, to obtain certification of course completion.

Learning Objectives:

• Demonstrate a basic knowledge of GMP requirements
• State the pivotal events that have shaped US laws on food, drugs and cosmetics
• Describe how the terms GMP and cGMP are used
• Identify key sections in the Code of Federal Regulations that impact drug manufacture
• Interpret these requirements for day-to-day operations
• Avoid the negative consequences of noncompliance
• Articulate how the organization can remain compliant with the regulations
• Instill a culture of compliance in the organization

Seminar Agenda:

PART 1 (11 AM – 12.30 PM)

• Food and drug oversight
• Pivotal events that shaped laws in US and scope of FDA actions
• Key sections in the Code of Federal Regulations (CFR) – 21 CFR 211
• GMP vs. cGMP
• Approaches to GMP (e.g. risk based approach)
• Consequences of noncompliance
  • What FDA inspects
  • FDA enforcement actions: Form 483, Warning Letter, Consent Decree, others
  • Pressures toward noncompliance
  • Scenarios and questions 
  • Substandard product: challenges and examples
• Notes on Labeling
• Review of good documentation practices
• Training responsibilities and appropriate training levels

PART 2 (12.45 PM – 2 PM)

• Building a culture of compliance
  • Quality infrastructure elements
  • Emphasis on education and decision-making
  • Training, memory retention, and accountability
  • Avoiding over-reliance on metrics
  • Stuff to watch out for
• Cost centers and profit centers: making a hardheaded assessment of risk and reward when assessing cost reduction initiatives
• Industry and governmental efforts to improve product quality worldwide
• New technologies, e.g. blockchain
• Conclusions, Q&A and Assessment

Who Should Attend:

• Quality Assurance Departments
• Quality Control Departments
• Research and Development Departments
• Regulatory Affairs Departments
• Manufacturing Departments
• Engineering Departments
• Operations Departments
• Production Departments
• Compliance Departments
• Packaging Departments
• Documentation Departments
• Training Departments

Course Director: Michael Esposito

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 workplan 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.