Qualiculture

Phama Biotech Services

TRAINING AND CAPABILITY BUILDING

We offer comprehensive training programs designed to develop the knowledge and skills needed to perform day to data activities complying to meet the challenges of a global and complex pharmaceutical industry. Our programs are frequently global in scope and may be tailored to a local language and culture along with knowledge assessment.

OUR KEY TRAININGS INCLUDE

Pharmaceutical Regulations – An Introduction
Current Good Manufacturing Practices (cGMP – ICHQ7)
Good Documentation practices
Aseptic processing / Sterility Assurance
Environmental Monitoring
Quality Culture – Data Integrity
Cleaning, Sanitization, and Disinfection
Sterilization Processes
Interventions Execution and Clean room Behaviour
Inspection readiness
Performing Effective Investigations (Deviations, OOS, and Market Complaints)
Good Documentation Review Practices – Batch Manufacturing Records and Analytical Test Records

These training courses concentrate on an overview of the comprehensive national and international regulations, relevant GMP guidance, and case studies.

CAPABILITY BUILDING

QualiCulture also assists the firms in capability building through specialized protocol-based exercises. The key capability Building Programs include:

Investigators Qualification
Internal Auditors Qualification
Aseptic  Operator’s  Practices and Techniques Qualification

By answering these questions we facilitate applying GMP on a day-to-day basis, promote understanding of GMP regulations, and foster a positive attitude towards GMP.

The workshops and group discussions on current issues also make the trainees become aware of GMP regulations and solve actual problems.

Our onsite training differentiates Basic and Special Training. While Basic Training provides fundamentals, Special Training help to advance knowledge or gain knowledge in one specific area.