- 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)
- 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
- GxP inspections from 1 January 2021
Requirements & who can attend:
- Quality Control Personnel
- Anyone who may be inspected by a regulatory body FDA or third party auditors
Learn by doing:
- 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