Overview of basic skills and importance of a Chemist- Production (Pharma, Cosmetics & Biologics) in a Non-Sterile product manufacturing processCopy

Introduction of functional and cross-functional stakeholders for Chemist – Production (Pharma, Cosmetics & Biologics)Copy

Various communication methods (verbal and written) for reporting incidents/ deviations.  Strategies for manpower management and optimization of team productivityCopy

Introduction of various type of audits in the life sciences sector for the manufacturing operations.Copy

Introduction of the Sexual Harassment of Women at Workplace (Prevention, Prohibition, and Redressed) Act and the provided penalties for violation at workplaceCopy

Importance of Standard operating procedures, equipment master list, and equipment qualification plan for production process.Copy

Process of calibration and validation of the equipment and balances used in the manufacturing area.Copy

Different types of pre-production checks performed in a production unit.Copy

Various troubleshooting methods and solutions for guidance to operators during production activities in consideration of critical process parameters and critical quality attributes.Copy

Role of assay and Quantity effect in biopharmaceutical formulation.Copy

Various method of reporting and documentation as per Good Documentation Practices (GDP) and other regulatory guidelines.Copy

Introduction of Attributable, Legible, Contemporaneous, Original, and Accurate Plus (ALCOA PLUS) principle and its importance.Copy

Overview and introduction of Drug Master File (DMF), Batch Manufacturing Record (BMR) and Batch Packaging Record (BPR).Copy

Industrial practices for generation of electronic and manual records in the log-books and other documentation required as per GMP and GDP.Copy

Management of Batch Manufacturing Record (BMR) and Batch Packaging Record (BPR) for each intermediate and finished non-sterile product.Copy

Introduction to working principle of machines and equipment used for various non-sterile product manufacturing process like tablet, capsule, liquid oral and their calibration and validation process.Copy

Introduction of ICH Q7 GMP guidelines for non-sterile product manufacturing.Copy

Application of various pharmaceutical and engineering concepts for troubleshooting in manufacturing process related to machines and equipment for tablet, capsule, and liquid orals.Copy

Process of cleaning validation for a non-sterile production area and equipment.Copy

Concept and procedure of root cause analysis for out-of-specification (OOS) and out-of-trend (OOT) products in case of deviations in production process.Copy