GMP Training – Institute of Fundamentals in Quality

100 % Placement Assistance

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Mentor’s Profile

Name of Mentor : Kumar Kurle

Qualification and certification

• Masters in Microbiology with strong subjective background of Chemistry, Biochemistry, biotechnology, molecular biology and Microbiology. And

certified GMP professional and six sigma black belt form American society of quality (ASQ)

❖ Profession

• 22 years of experience in pharmaceutical and biopharmaceutical industries like Cipla, Wockhardt, Emcure, Piramal and Dr. Reddy’s laboratories. Pharmaceutical quality consultant and a passionate trainer.

❖ Skills

• Problem solving, Training, mentoring, Risk assessment, Six Sigma

❖ Experience and Expertise

• Rich experience in quality systems implementation, regulatory audits and compliance, technology transfer, process development & scale up of

pharmaceuticals and bio-pharmaceuticals APIs and finished products. He is adept in Equipment validation, computer system validation, Process

and cleaning validation, specifications and Analytical Method Development and validation involving Chemistry, Biochemistry, Molecular Biology and Microbiology.

• Expertise includes management of diverse business processes with implementation of latest Quality Management Tools; preparing the Quality

Assurance Plans, handling customer complaints, deviations, Change and CAPA management.

• Deep understanding of pharmaceutical manufacturing and quality control processes including API synthesis, fermentation, protein purification,

sterile and non-sterile fill finish operations.

• Deep understanding, interpretation and implementation skills of national and international regulatory requirements and guidelines.

Training and Services offered

 1) GMP Training for graduates and entry level candidates in pharma industries

2) Advanced GMP training for experienced pharma professionals

o Improving documentation skill

o Deviation investigation and report writing

o CAPA management

o Process validation and Continuous process performance verification

o Analytical method validation and Continuous method performance verification

o Risk management

o Change management

o Equipment validation and life cycle management

o Use of statistical tools in trending and conducting product reviews

o Design and maintenance of quality system

1. GMP Training for graduates and entry level candidates in pharma industries

Who should attend

• Fresh Graduates (MSc Chemistry, microbiology, biotechnology, Pharmacy and
engineering graduates/ post graduates) seeking jobs in
pharmaceutical industry
• Fresh graduates joined within 1 to 2 years in pharmaceutical
industry.
 

Why take this course

 • Clarifying your purpose of pursuing career in pharmaceutical
industry
• Understanding Good Manufacturing Practice (GMP) and
expectations of pharma industries form buddies.
• Understand pharmaceutical product life cycle
• Understanding different processes in GMP
• Understanding of Glossary of GMP terminologies
 
• Gain quick adaptability to the industrial environment with pre-
equipped knowledge and skills
 
• Improve documentation skills and data integrity expectations
• Improve job performance and career growth
 

Course Content

• Introduction to GMP
• Introduction to various functions in pharma industry
• Quality System (QC & QA)
• Phases of product development
• Different manufacturing processes utilized
• Quality control processes
• Material control
• Personnel, Premises and Facility requirements
• Equipment controls
• Validation requirement
• Documentation preparation skills for GMP (SOPs, Specifications, protocols, reports, batch records)
• Developing product and process know-hows
• GMP expectations form major regulations (drugs and cosmetics act, US-FDA and EU-GMP)
• Examination and Certification from IFQ
 

Duration of course :

 5 days – 9am to 5pm per batch
 

2. Advanced GMP training for experienced pharma  professionals

Who should attend

• Quality assurance professionals
• QA, QC, manufacturing, Engineering staff involved in validation
and maintenance
• Staff involved in quality audit and compliance
 

Course topics offered in Advanced GMP training

Standard as well as customized course content as per organization and personnel requirements
o Improving documentation skill
o Deviation investigation and report writing
o CAPA management
o Process validation and Continuous process performance verification
o Analytical method validation and Continuous method performance verification
o Risk management
o Change management
o Equipment validation and life cycle management
o Use of statistical tools in trending and conducting product reviews
o Design and maintenance of quality system
o Application of Six-Sigma in pharmaceutical quality assurance and engineering services
o Guidance on ASQ-GMP professional certification (CPGP).


Duration of course

• 2 days – 9am to 5pm per batch
 

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