Training

GBH Group has the tools & experience to meet our clients’ needs for cGMPs and validation training.

Training of personnel is not only a regulatory requirement but also a prerequisite to functional and efficient operations in every life sciences company. GBH Group offers on-site training sessions adapted to your activities and needs. We take into account and use in our training sessions, when needed, your tools and documents, with the ultimate goal of making these training sessions concrete and useful in your daily activities.

As training is essential part of GMP compliance, GBH Group provides these main training programs:

• GMP and Quality assurance :

·  GMP (Good Manufacturing Practices) Introduction

·  Basics Of  cGMPs)

·  Sanitation and Hygiene

·  Good Documentation Practices

·  GMP of Sterile Production

·  GMP For Engineers

·  Pest Control and Management

·  GMPs for Quality Control Laboratories

·  Standard Operating Procedures (SOP)

·  Quality Assurance and Quality Control

·  Change Control

·  Working in Clean rooms

·  Recall and Traceability Systems

• Validation:

·  Streamlining Validation

·  (An integrated approach to validation)

·  Validation Master Plan

·  Validation of sterilization processes

·  Validation and Engineering

·  Validation of analytical methods

• Engineering

·  Design of clean rooms

·  Major elements of purified water systems

·  Ventilation systems in the pharmaceutical industry

• Product Development:

Effect of particle size on manufacturing process, particle size trouble shooting and how to avoid problems related to API.

How to avoid the effect of Physical properties of API (Flow ability, Density, compressibility, crystallinity, polymorphism) on manufacturing process and effect of RM forms on drug stability and how to distinguish between polymorphism by using Modulated Temperature Differential scan calorimeter.

Analytical Standards, types, handling, preparation, and disposing  

Pre-formulation Studies for APIs

Selection of polymorphism and how does it affect  the dissolution and stability results of finished product

Laser particle size analyzer operation, theory applications for micronized particles, and results analysis    

API Suppliers evaluation, selection and dealing with new supplier

API GMP Guidance Q7A

Common Technical Drug master files preparation (CTD format)