Good Manufacturing Practices (GMP) – 2019 and Beyond Training

Course Details:

  • Changes to former requirements
  • Best practices on how to achieve compliance.
  • manufacturer license holders
  • wholesale dealer license holders
  • blood establishment authorization holders
  • non-UK sites employed by UK MA holders
  • Inspections under the risk-based compliance program
  • compliance report
  • internal information about previous inspection history
  • organizational changes
  • Committee for Human Medicinal products (CHMp)
  • Co-ordination group for Mutual Recognition and Decentralised Procedures

 

What you will learn:

  • (GxP) inspections and coronavirus COVID-19)
  • Overview
  • Types of inspection
  • Complete a compliance report
  • The inspection
  • Grading of inspection findings
  • Actions after the inspection
  • Feedback from GMP inspections
  • Suspension of your licence
  • Transitional Qualified Persons (QPs) for investigational medicinal products (IMPs)
  • Fees for inspection
  • Contact
  • GxP inspections from 1 January 2021

 

Requirements & who can attend:

  • Operations
  • Quality Control Personnel
  • Anyone who may be inspected by a regulatory body FDA or third party auditors

 

Learn by doing:

 

Able to-

  • Understand the components and requirements of cGMP within the food and beverage industry.
  • Implement cGMP through the organization to ensure sanitary and processing requirements are being met.
  • The participants will learn and understand the revised (cGMP’s) – according to the final rule for “Preventive Controls for Human Food”, released on September 17th, 2015.
  • Participants will learn how to handle FDA and third party Good Manufacturing Practice (GMP) inspections

Course at a Glance

Price:

Starting and Ending Date

Last Date of Registration

Class Schedule

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