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 IntroductionCurrent Good Manufacturing Practices (cGMP – ICHQ7)Good Documentation practicesAseptic processing / Sterility AssuranceEnvironmental MonitoringQuality Culture – Data IntegrityCleaning, Sanitization, and DisinfectionSterilization ProcessesInterventions Execution and Clean room BehaviourInspection readinessPerforming Effective Investigations (Deviations, OOS, and Market Complaints)Good Documentation Review Practices – Batch Manufacturing Records and Analytical Test RecordsThese 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 QualificationInternal Auditors QualificationAseptic Operator’s Practices and Techniques QualificationBy 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.