Recording
Recording

Duration: 3 Days | Course Director: Charles H. Paul


$1900 
  • SKU: SEM3560

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PRE-REGISTRATION AVAILABLE 

If you want to have this training scheduled Live and Exclusively for your company, we will arrange it for you.

Pre-Register now and pay only once the training is scheduled on your preferred days.


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.


SEMINAR OBJECTIVES
WHO SHOULD ATTEND
  • List and describe the regulations governing Good Manufacturing Practices
  • State the personal responsibilities as they relate to GMPs.
  • List and describe the regulations in the 21 CFR regulations that pertain to GMPs.
  • Explain how to prepare for a GMP inspection
  • List and describe the consequences of not being prepared for an FDA inspection
  • Explain how the FDA inspection is structured and conducted
  • Explain how the organization should be structured for the FDA Inspection
  • Explain the importance of truthfulness when interacting with FDA inspectors
  • List and describe the tricks inspectors use to elicit information
  • Explain how employees should behave during an inspection
  • Explain how organizations should handling adverse findings at the completion of an inspection



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

  • Quality Departments
  • Production Departments
  • Compliance Departments
  • Engineering Departments
  • Manufacturing Departments
  • Operations Departments




AGENDA

DAY 1 (11 AM to 3 PM)

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



 


DAY 2 (11 AM to 3 PM)

GMP Inspections

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


DAY 3 (11 AM to 3 PM)

GMP Inspections

- 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


Course Director: CHARLES H. PAUL

Charles Paul is an instructional designer and management consultant with over 30 years’ experience providing training and consulting services to regulated industries. He has installed quality systems and designed and developed GMP and operational documentation and training programs for foods and beverage, pharmaceuticals, biotech, cosmetics, and consumer product – OTC industries.