TRAINING TOPICS

LABORATORY GMP/GLP

·          WHY GLP/GMP?

·          WHO APPLIED?

·          RESPONSIBILITIES

·          TRAINING

·          LAB. GENERAL

EQUIPMENT

·          LABEL KNOWLEDGE

·          LOGBOOKS

·          WHICH EQUIPMENT SHOULD BE CALIBRATED?

cGMP

 

·          COMPARISON OF EU AND  FDA cGMP REQUIREMENTS

·          CONSENSUS AREAS

·          CRITICAL DIFFERENCES

DOCUMENTATION OF GDP

·          HOW MUCH DATA SHOULD BE RECORDED?

·          RECORD OF LOGBOOKS OR FORMS?

·          EVALUATION OF DEVIATIONS

·          RAW DATA

QUALITY SYSTEMS APPROACH TO cGMP REQUIREMENTS

·          RISK -BASED APPROACH

·          QUALITY SYSTEMS AND cGMP RELATIONSHIP

·          QUALITY DESIGN

·          CAPA

·          QUALITY RISK MANAGEMENT

·          CHANGE CONTROL

·          QUALITY UNIT

HYGIENE

·          DIFFERENCE BETWEEN CLEANING AND HYGIENE

·          EMPLOYEE HYGIENE PRACTICES

·          THE IMPORTANCE OF THE CHOICE OF DISINFECTANT

·          DETERMINATION OF DISINFECTANT EFFICACY

RISK MANAGEMENT

·          RISKS AND HAZARDS

·          RISK MEASURES

·          PROACTIVE APPROACH TO RISK

·          PROCESS PLANNING

·          TYPICAL PRODUCTION PROCESSES

·          POTENTIAL HAZARD ANALYSIS

·          EVENT TREE AND FAULT TREE ANALYSIS

·          HAZOP

·          FME(C)A

·          HACCP

PROBLEM SOLVING TECHNIQUES

·          TOTAL QUALITY, CONTINUOUS IMPROVEMENT

·          DEFINITION OF THE PROBLEM, METHODOLOGY OF PROBLEM SOLVING

·          WORKING METHODOLOGY OF IMPROVEMENT TEAMS

·          WH QUESTIONS

·          BRAIN STORMING

·          CAUSE AND EFFECT DIAGRAM

·          PARETO ANALYSIS

·          DATA COLLECTION TECHNIQUES

·          PROCESS FLOW MAPS

·          FISHBONE DIAGRAM

·          PYSU

STANDARTS AND SAMPLES

·          HOW TO CLASSIFICATION ?

·          WHICH INFORMATIONS SHOULD BE RECORDED?

·          LAB. STUDIES

·          RECORDS AND REPORTS

·          EVALUATION OF OOS

·          WHAT IS OOS?

·          RESEARCH PRINCIPLES

·          RESPONSIBILITIES

·          IF FINDS  VALID REASONS?

·          IF DO NOT FIND VALID REASONS?

·          RE-TEST?

·          RE-SAMPLING?

·          OUTLIER TEST?

·          DECISION

·          HOW TO AVOID OOS?

GMP TRAINING

 

COMING TO YOU!

WHERE YOU ARE IN THE WORLD!

 

Where you are in the world, İpsum Validation brings all GMP trainings to your doors! We offer to you  price / effective solutions because of  travel expenses of whole your staff. This training designed to reflect whole current WHO, PIC/S,FDA and EU GMP regulations to your staff.

 

WHAT WİLLYOU LEARN?

·          cGMP history and current GMP major titles

·          cGMP 's  basics and documentation structure

·          How to integrated cGMP requirements into the daily work?

·          How to access quickly  to cGMP informations?

·          Understanding the importance of  roles  for cGMP Compliance

·          Understanding the contamination and microorganisms

·          How do cleanrooms work?

·           Appropriate behavior in GMP  facilities

·           Relationship between  GMP,  Quality Assurance  and  Quality Control

·           Minimizing of GMP documentation errors and GMP requirements in the documentation system