Fundamentals of Good Manufacturing Practices (GMP): Developing a Compliance Mindset Webinar

MP3 Download / Online On Demand Duration 75 Mins

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Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

Training Overview

A discussion of the basic principles and requirements for Good Manufacturing Practices. Presentation provides:

  • a brief history of GMPs
  • and basis in law and regulations for the existence of GMPs,
  • a detailed discussion of what they cover
  • a discussion of what they mean, e.g., segregated into appropriate operations – several examples of how companies have segregated their operations.
  • examples of real-life situations along with a discussion of possible responses and the reasons one or more responses may be appropriate or not.

The fundamental goal of the presentation is to not just list all the regulations, but discuss what they mean, how a compliance mindset changes your perspective from just following the law to understanding the reasons for the regulations and how to make GMP a part of your day to day thinking

Why Should You Attend

Working in a regulated industry requires a specific mindset. Too often personnel don’t understand the necessary mindset or don’t follow the necessary mindset either out of ignorance or other factors. Add value to your resume, ensure you have the right mindset.

Webinar Takeaway

  • Good Manufacturing Practice fundamentals
  • GMP principles
  • Data Integrity Principals found in GMPs
  • Summary of specific areas covered throughout GMPs
  • Organization and Personnel
  • Building and Facility requirements
  • Equipment Management
  • Material Handling
  • Production and Packaging Controls
  • Laboratory Operations
  • Case Study example scenarios with discussion of best answers

Key Learning Objectives

  • Fundamental requirements of Good Manufacturing Practices (FDA based)
  • Law
  • Regulations
  • Guidance
  • Basic Principles the GMPs require – go beyond if it’s not written down it didn’t happen
  • Linkage to Data Integrity – principles of ALCOA
  • Brief history of the evolution of the GMPs worldwide
  • Learning how to approach operations from a compliance mindset to ensure success in any situation
  • Understand how to choose the right answer when several alternatives are available

Who Will Benefit

  • Regulated industries – Pharma
  • Bio-pharma
  • Medical Device – all aspecs from clinical to commercial.

David W. Husman, Ph.D., ASQ CPGP, RAC

Experienced Consultant in Pharmaceutical and Medical Device Industries |Trainer | Based in Greenville |Open to Traveling

Taylors, South Carolina

Over 30 years of diverse international industry experience in Quality Assurance, Quality Control and Regulatory Affairs. Last 20 years as a consultant to biopharma, pharma and device industries.

Experience has spanned from R&D to Commercial Manufacture

Background includes, but not limited to, parenteral products, human tissue products, blood products, biotech products, solid dosage, vaccines, implantable devices, and in vitro diagnostic products for both human and animal species.

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Our Participants Testimonial

The presentation by Carolyn Troiana today was fantastic, both I and the QA Manager (Aaron Neighbour) loved it and had extensive conversation afterward about it. ( FDA Compliance and Mobile Applications Webinar )

Robert Friedland ( IT Manager) NUTEK BRAVO, LLC.

Thank you for providing the information in such detail. It was helpful to gain the perspective of somebody that has implemented these regulations in a working lab. Virtual Seminar on ( Training on Life cycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines )

Tracey Kessler ( Director of R&D) CEL-SCI Corporation

I felt the seminar was very helpful and provided good insight for DataIntegrity and what the FDA is looking for per the regulations. ( Current Regulatory Thinking on Data Integrity 2 Days Virtual Seminar )

Margaret A. Clifton ( Manager, Quality Systems) CSL Plasma

The presenters subject matter knowledge is extensive which enables information to be shared in detail. (Training Attended on Risk Based Verification and Validation Planning to Meed US FDA and ISO 13485 Requirements )

Stuart Chisholm (Sr. Principal Device Engineer) Teva Pharmaceuticals

About World Compliance Seminars (WCS)

World Compliance Seminars (WCS) is one stop solution for all your pharmaceuticalbiotechnology and medical device certification program needs. The pharmaceutical and medical device training requirements are set forth by the FDA (Food and Drug Administration) and other major regulatory bodies like NIHEMA, as well as numerous European based national regulatory bodies.

These requirements are important to the training of pharmaceutical reps who are responsible for the education, professional development, and on-the-job training. The training is broken down into different sections to cover a wide variety of topics, including pharmaceutical formulation, pharmaceutical transfer processes , GLP, GMP, Clinical ComplianceProcess Validation, Global Regulatory Affairs, Document Management,GMP (Good manufacturing practice) QSR and CMC and many more.

The pharmaceutical and medical device requirements that the FDA has set forth are designed to protect the public's health and safety. Pharmaceutical reps must adhere to all of the regulations and education courses provided by the FDA in order to be considered one of the best in their field. They also must complete ongoing educational opportunities and maintenance programs in order to maintain relevance and career enhancement.

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