Programmes

Training & Consultancy
 Good Manufacturing Practice Training

Training Good Manufacturing Practice Guidelines

Setax offers Training and Consultancy services. 

A) TRAINING DIVISION

With over 10 years of training experience in the Pharmaceutical Industry, we   provide quality Good Manufacturing Practice (GMP) training services to satisfy and meet your training requirements to GMP compliance.

We make available the necessary resources to ensure we fully comprehend your training requirements using our in-house training analysis process. It is absolutely vital that the training needs of our clients are fully attained   and comply with Good Manufacturing Practice guidelines as this adds absolute value to the training, ensuring you get value for money.

Courses for the Pharmaceutical Industry

  • Principles of Good Manufacturing Practice
  • Deviation Management /Corrective Actions & Preventative Corrections Management
  • Developing a Compliant Quality Management System
  • Change Control
  • Equipment Qualification & Validation
  • Concept of Technology Transfer
  • Good Documentation Practice
  • GMP Audits
  • The Importance of Data Integrity in Pharmaceutical Quality Management System
  • Understanding of the False Medicines Directive (FMD)  and its Impact on the Pharmaceutical Supply Chain
  • Comprehension and the Application of the Principles of Quality Risk Management
  • Principles of Good Distribution Practice
  • Equipment & Premises Management
  • Internal Audits Management
  • Documentation Management
  • Writing Standard Operating Procedures
  • Product Quality Complaints
  • Recall Management
  • Computer System Validation

Course materials

Participants will receive a copy of the presentation(s), relevant notes and workshop materials.

A certificate of completion will be issued to participants who successfully complete the assessment.

Assessment

A written assessment is conducted at the end of all  courses.

Course Format

The course is a combination of lecture-style learning and active workshops with participants working in small groups on assigned tasks.

Cost of Course: Enquire for details

You just do not complete feedback forms and wave “goodbye and walk away. We establish an effective follow-up strategy for a defined period to ensure the agreed learning  outcomes are implemented and achieved.

Where required we can assist with writing standard operating procedures around the subject matter.

For a free consultation on understanding your training requirements.  contact ibelemaemeh@setaxtrainingconsultancy.com

 

B) CONSULTANCY DIVISION

With over 20 years of experience in the Pharmaceutical Industry working to GMP compliance.   We have worked with various pharmaceutical companies viz: Shire, GlaxoSmithKline, Roche, and Celltech. You can be completely confident and assured that we possess all the experience and knowledge of the working of the Quality Management System Environment ensuring compliance to Good Manufacturing Practice guidelines.

Setax can provide interim support (ranging from 1 day to 12 weeks or more as per your requirements) for your QMS in the following areas:

·       Closing out overdue deviations/CAPAs and Change Controls, ensuring the application of the appropriate      Corrective actions/Preventative actions and Effective checks.

·       Self –Inspections (Internal Audits).

·       Data Integrity

·       External Audits

·       Supplier management activities/audits

·       Review of QA documentation

·       Writing SOPS

·       QA training

·       Regulatory inspections

·       Review of QMS from a GMP perspective

·       Completing Product Quality Reviews

·       Other QA activities

·       Provide support for regulatory inspections

Our consultants ensure they are kept up to date with current GMP regulations by attending the yearly MHRA GMP/GDP Conferences and participating in various QA forums in LinkedIn.

Where applicable, we apply project management principles and tools to manage your projects.