GMP master class – get it right to avoid compliance issues 

Overview

CGMPs or Current Good Manufacturing Practices is a general encompassing term for the regulations that the control of all facets of life sciences manufacturing processes and facilities particularly pharmaceutical products.

It is crucial, for any entity to be compliant, that every individual within the organization fully understand and adhere to these regulations in the course of

Adherence to those regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories. This formal system of controls if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors. This assures that drug and medical device products meet their quality standards.

The CGMP requirements were established to be flexible in order to allow each manufacturer to decide individually how to best implement the necessary controls by using scientifically sound design, processing methods, and testing procedures. The flexibility in these regulations allows companies to use modern technologies and innovative approaches to achieve higher quality through continual improvement. Accordingly, the "C" in CGMP stands for "current," requiring companies to use technologies and systems that are up-to-date in order to comply with the regulations. Systems and equipment that may have been "top-of-the-line" to prevent contamination, mix-ups, and errors 10 or 20 years ago are less than adequate by today's standards.

It is important to note that CGMPs are minimum requirements. Many manufacturers are already implementing comprehensive, modern quality systems and risk management approaches that exceed these minimum standards.

Why Should You Attend

Understanding GMP requirements, refreshed on a yearly basis is critical to maintain high-GMP standards in your company. Knowledge and skill surrounding the application and practice of GMPs is fundamental to avoiding regulatory issues. It’s simple – you have to do it and you and your team must comply. You cannot assume that once taught, the content associated with GMPs will be retained from year to year. As human beings, we tend to forget over time and as we forget, we also get careless. In the health sciences there is no margin for error or tolerance for carelessness. This training will provide foundation to your GMP training.  

Agenda

GMPs – Government Regulations

• What are the regulations governing Good Manufacturing Practices?
• Your responsibilities
• Pertinent GMP topics as per the code of Federal Regulations
• Quality Management
• Personnel
• Premises and equipment
• Documentation
• Production
• Quality Assurance
• Materials management
• Production and in-process controls
• Packaging and labeling
• Storage and distribution
• Laboratory controls
• Validation
• Change control
• Rejection and re-use of material
• Complaints and recalls
• Supplier controls

GMP Inspections

• Preparing for a GMP Inspection
• The consequences of not being ready
• The specific areas that are inspected during a GMP inspection

FDA Inspection Tips and Recommendations

• The FDA Inspection – how is it structured and conducted
• Responding and organizing for the FDA Inspection
• Importance of truthfulness
• Importance of knowledgeability and confidence
• FDA Tricks to elicit information
• Arguing and challenging
• Behavior during the inspection
• Importance and role of documentation
• Effective communication skills
• Being deceptive
• Opinion versus fact
• Phrases never to say
• Handling adverse findings during the inspection

Who will Benefit

Virtually everyone in the health sciences, everyone within the organization, can benefit and in most cases, is required to attend periodic GMP training.

• Compliance
• Quality
• Marketing
• Engineering
• Operations