RSS Newsfeed  Your shopping cart.
ECA Academy - Your GMP/GDP Information Source
SEARCH

Search in

Keyword

 

In-house Training Programme

 
 

Basic GMP Course
Regulatory and GMP Requirements for Pharmaceutical Companies

 
     
 
When What
8.00 - 8.30 Welcome, Introduction, Presentation of the Speaker
8.30 - 9.30

Regulations in Europe

  • Directives
  • Guidelines
  • Notices

Regulations in the USA

  • CFR
  • Guidances
  • FOI

Harmonised Regulations

  • WHO
  • PIC
  • ICH
  • GHTF
  • ISO
9.30 - 10.45

GMP in Manufacturing

  • Quality of Starting Material
  • Production Process
  • Packaging and Storage
  • Contract Manufacturing
  • Responsibility
10.45 - 11.00 Break
11.00 - 12.15

GMP in Quality Control

  • Duties of Quality Control
  • Differences Between Europe And USA
  • Qualified Person
  • Validation of Analytical Methods
  • Performance of Analytical Methods
12.15 - 13.15 Lunch
13.15 - 14.30

Documentation

  • SOPs
  • Batch Documentation
  • Quality Control Documentation
  • GMP-Based Documentation
  • GMP Relevant Documents
  • Archiving
14.30 - 14.45 Break
14.45 - 15.45 

Qualification and Validation

  • Definition and Differences
  • Validation Master Plan
  • Validation Team/Performance of Validation
  • Responsibilities
15.45 - 16.45

Change Management

  • Deviation
  • Change
  • Definition and Differences
  • Out of Specification
  • SOP
16.45 - 17.15

Training and Self-Inspection

  • Performance of Training
  • Performance of Self-Inspections
  • SOP
  • Documentation
 
 
GMP in-house Training Courses are an ideal solution for ten or more people and are very cost-effective. We come to you at a time and date to suit your organisation.

Please contact us if you are interested in a detailed offer.

The above agenda proposal has been developed for an in-house training course (group of participants). If you are interested to participate as an individual person please check our list of GMP training courses and conferences.

 

 GMP Conferences by Topics
 Quality Assurance
 GMP in Biotechnology
 Microbiology
 Regulatory Affairs
 GMP in Pharmaceutical Development
 Quality Control
 Storage, Distribution, Transportation
 Sterile / Aseptic Manufacturing
 Computer Validation
 Technical Operations
 GMP for APIs and Excipients
 Validation
 Medical Devices
 GMP Basic Training Courses
 Packaging