3 Day GMP (Good Manufacturing Practices) Virtual Master Class: Get it Right to Avoid Compliance Issues

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Nov 17, 2023, 21:45 ET

DUBLIN, Nov. 17, 2023 /PRNewswire/ -- The "GMP Master Class - Get it Right to Avoid Compliance Issues" training has been added to ResearchAndMarkets.com's offering.

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.

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.

RAPS - This course has been pre-approved by RAPS as eligible for up to 8 credits towards a participant's RAC recertification upon full completion.

Who Should Attend:

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

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

Speakers:

Charles H. Paul
President
C. H. Paul Consulting, Inc.

Charles H. Paul is the President of C. H. Paul Consulting, Inc. - a regulatory, manufacturing, training, and technical documentation consulting firm - celebrating its twentieth year in business in 2017. He has been a regulatory and management consultant and an Instructional Technologist for 30 years and has published numerous white papers on various regulatory and training subjects. The firm works with both domestic and international clients designing solutions for complex training and documentation issues.

He has held senior positions in consulting and in corporate training development prior to forming C. H. Paul Consulting, Inc.. He also worked for several years in government contracting managing the development of significant Army-wide training development contracts impacting virtually all of the active Army and changing the training paradigm throughout the military.

He has dedicated his entire professional career explaining the benefits of performance-based training

For more information about this training visit https://www.researchandmarkets.com/r/6vpo6m

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SOURCE Research and Markets