Who should attend?

WHO SHOULD ATTENDS?

This course is specifically designed for people who staff their company's booth at

Trade fairs.

  Objectives                

The objective of the program is to coach participants in the fundamentals of GMP.

 The three days training program, has been devised specifically as a Foundation Course. Participants will have the opportunity to obtain the optimum understanding of the different elements that make up GMP.

The training opens and develops in such a way to bring the participants together and put them at ease with the trainer and, of course, the other way round to form a relaxed and informal climate

  Contents:

Module 1: International GMPs and Principles of Quality Management

Describe the historical developments of cGMPs (FDA, PIC/S, and ICH) and their evolution into international compliance programs.

Explain the differences between regulations, codes of practice & guidance.

Review fundamental requirements for GMPs & the obligations of manufacturers and managers.

Interpret the requirements of different regulatory agencies

Module 2: Documentation Systems and Practices - GMP Requirements & Control

Explain the structure of GMP documentation, expected format & control.

Explain the relationship between Manuals, Policies, specifications, SOPs, Work Instructions, Records & other supporting documentation.

Specific case study on Ideal batch record will be presented in this course.

Develop a model hierarchical documentation system based on ISO 9001.

Link training plans and strategies to compliant documents

Describe the importance of documents & records during GMP audits.

Module 3: HVAC and Controlled Environments - control and qualification

Explain key design requirements for controlled manufacturing environments

Develop regulatory requirements for HVAC systems & environmental monitoring

Successfully manage the validation of HVAC systems

Explain the theory of particle filtration

Module 4: Pharmaceutical Water Systems: Design, Control & Validation

Understand the requirements for design, validation & control of pharmaceutical water systems according to current cGMPs.

Be familiar with water system validation guidelines, IQ, OQ & PQ requirements, BP/USP standards & microbiological controls.

Module 5: Cleaning Validation

Interpret regulatory requirements and guidelines.

Establish residue limits and calculate sample acceptance criteria to define clean.

Select sampling and analytical methods to measure cleaning.

Prepare cleaning validation protocols

Module 6: Handling Laboratory Out of Specification (OOS) Conditions

Explain the origin of out of specification rules

Interpret accurately the FDA guidance for OOS situations

Develop SOPs and records for OOS management

Explain category 1 - 4 OOS conditions

Effectively investigate OOS conditions