API manufacturing companies

Research and Development

❏ Process development

❏ API

❏ Analytical methods development and validations

❏ Technology transfers

Manufacturing

❏ SOP, documentation procedures

❏ Unit operations

❏ Equipment and facility Validations

❏ Risk assessment of processes of pharma manufacturing

❏ Contamination control

❏ Cleaning of area, equipment

❏ Water system (Pre-treatment, Purified water)

Quality Control

❏ Chromatography

❏ Spectroscopy

❏ Titrations

❏ Sampling Techniques

❏ Particle Size distribution

❏ Polymorphism

❏ Stability Studies

Quality Assurance

❏ Drugs and cosmetic Act / Schedule M

❏ Pharma management, code of conduct and ethics and Best Practices

❏ Basic GMPs

❏ Review of Raw data and Audit trail review

❏ Annual Product Quality Review

❏ Failure Investigations

❏ Data Integrity

❏ 21 CFR part 11

❏ Vendor Management

❏ Warehousing procedures

Regulatory affairs

❏ Introduction to procedures of various regulatory agencies for DMF filing.

❏ Regulatory inspections and readiness

❏ Expectations from the regulatory agencies on compliance

Training Titles

Formulations manufacturing companies

Research and Development

❏ Process development

❏ Formulations

❏ Analytical methods development and validations

❏ Technology transfers

Manufacturing

❏ SOP, documentation procedures

❏ Unit operation

❏ Environmental monitoring and area qualifications

❏ Validations of facility and equipment

❏ Risk assessment of processes of pharma manufacturing

❏ Contamination control

❏ Cleaning and sanitization of area, equipment

❏ Aseptic gowning and conventional gowning, design

❏ Visual inspections

❏ Hand disinfection and Aseptic behaviors

❏ Water system (Pre-treatment, PW, WFI and pure steam generation, distribution)

❏ Air velocity monitoring

❏ Smoke study

Quality Control

❏ Chromatography

❏ Dissolution analysis with HPLC

❏ Spectroscopy

❏ Titrations

❏ Sampling Techniques

❏ Particle Size distribution

❏ Stability Studies

Quality Assurance

❏ Drugs and cosmetic Act / Schedule M

❏ Pharma management, code of conduct and ethics and Best Practices

❏ Statistical tools

❏ Basic GMPs

❏ Review of Raw data and Audit trail review

❏ Annual Product Quality Review

❏ Failure Investigations

❏ Data Integrity

❏ 21 CFR part 11

❏ Vendor Management

❏ Warehousing procedures

Regulatory affairs

❏ Introduction to procedures of various regulatory agencies for ANDA filing

❏ Regulatory inspections and readiness

❏ Expectations from the regulatory agencies on compliance