cGMP Application for Design & Operation

Event Information
Product Format
Prerecorded Event
Conference Date
Thu, Nov 05, 2015
90 minutes
Product Description

Get Expert Advice on Meeting FDA’s Current GMP Regulation Requirements with an Effective Quality Management System

Good Manufacturing Practices (GMP) were established by the pharmaceutical industry in the 60s and 70s as requirements for the manufacturing of food, drugs, and medical devices to ensure their quality and minimize risk to patients or consumers. Current Good Manufacturing Practices (cGMP) regulations require a quality management system, including documentation of each step of manufacture and analysis of potential risks to patients or consumers from adulterated or non-conforming products. It is further required that test results prove that the product is ready and acceptable to be distributed with little to no patient risk.

This session by expert speaker Jerry Dalfors will help manufacturers implement cGMP quality systems and risk management approaches during commercial operations and development, after the initial preclinical studies. Jerry will provide you expert advice on cGMP quality systems and risk management so that you’re able to meet FDA’s current good manufacturing practice (cGMP) regulation requirements. The program will explain how manufacturers can implement good manufacturing practices with quality management systems that are compliant with parts 210 and 211.

Session Highlights:

  • Understand the concept of CGMPs and current quality systems – which include risk management, change control, quality by design and development, CAPA, manufacturing, management responsibilities, resources and evaluation activities.
  • Review terms and definitions related to cGMP– with related acronyms.
  • Discover how good QMSs are structured to make quality match with profitability.
  • Understand documentation requirements – entering data, reviewing comments, and making corrections.
  • Learn the relationship between management responsibility and GMP/quality commitments.
  • Consider how to implement a quality policy on the job, both for general elements of the manual and individual training needs for every job description.
  • Learn how to present cGMP requirements to HR so they can vet incoming employees and design training programs around cGMP/QMS compliance.
  • Get step-by-step guidance on implementing best practices via cGMP.
  • Understand purchasing, incoming control and raw material release.
  • Understand gowning, environmental control and monitoring.
  • Best practices for product testing, inspection and document review for final product release.
  • Get an in-depth knowledge of incident tracking, change control, CAPA and annual quality review.

Who Should Attend

  • FDA, ISO, PDA, ISPE, ASQ related employees
  • Any part of the industry involved in the manufacture of Food, Drugs and Medical Devices or any other product regulated by government agencies

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

Order Below or Call 1-866-458-2965 Today

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About Our Speaker

Jerry Dalfors

Mr. Jerry Dalfors has extensive (40+ years) of business administration, consultative, technical and managerial experience in the development and manufacture of highly regulated biopharmaceutical products including injectables, biologics, medical devices and oral dosages. He has held permanent employee, temporary employee and company representative management positions with a multitude of the major pharmaceutical and biotechnology companies in the US.

He has worked with or...   More Info
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