Training

Expert-Led Training for Regulatory and Operational Success

Comprehensive Coverage – Trainings in cGMP, Quality, Validation, Automation, and Professional Skills.
Regulatory Aligned – Programs based on USFDA, EU GMP, WHO, ICH, and ISO guidelines.
Practical & Industry-Focused – Delivered by experts with hands-on experience and real- world case studies.
Customized Solutions – Tailored modules for pharma, biotech, API, food, and cosmetics industries.

Overview of the Pharmaceutical and Biopharmaceutical Industries – Covers drug development, manufacturing processes, market segments, and global regulatory landscape.
Auditing Authorities – Explains international and national regulatory bodies such as USFDA, EMA, WHO, and their roles in compliance.
Regulations – Provides insights into the evolution of pharmaceutical regulations and GMP standards, key global regulatory requirements including USFDA, EU GMP, WHO, and ICH guidelines.
Drugs & Cosmetics Act and Schedule M – Explains Indian regulatory requirements for pharmaceuticals and GMP standards.
GxP – Introduces Good Practices (GMP, GLP, GCP) and their relevance in regulated industries.

Introduction to QMS – Explains the structure and components of a Quality Management System for compliance and efficiency.
ISO Modules – Introduces ISO standards relevant to pharma and biopharma, emphasizing quality and safety.
Data Integrity, Audits, Quality, Validation, and Compliance – Key compliance and operational topics.
Quality Management – Introduces QMS principles, policies, and best practices for maintaining quality standards.
Quality Risk Management – Risk assessment and mitigation strategies as per ICH Q9.
Laboratory Controls and Compliance Practices – Explains lab operations, testing controls, and compliance with regulatory expectations.
Document Control – Focuses on controlled document management and lifecycle to ensure compliance and traceability.
Records and Reports – Explains proper creation, maintenance, and control of GMP-compliant records and reports.
Self-Inspection and Quality Audit – Covers internal auditing and self-inspection methods to ensure compliance readiness.
Independent trainings on QA concepts such as Deviations, Change Controls, CAPA, Incidents, Internal Audits and so on.
483 and Warning Letters – Discusses FDA 483 observations, warning letters, and their impact on pharmaceutical operations.

Current Good Manufacturing Practices (cGMP) – Introduces current Good Manufacturing Practices essential for compliant pharmaceutical production.
Safety in Pharmaceuticals – Emphasizes workplace and product safety measures in manufacturing facilities.
Sanitation and Hygiene – Covers practices for maintaining a clean and contamination-free production environment.
Organisation and Personnel – Covers organizational structure, roles, and responsibilities to meet GMP requirements.
Packing and Labelling Control – Details procedures for packaging, labeling, and avoiding mix- ups or errors.
Product Manufacturing Process – Explains the stepwise manufacturing process for various dosage forms.
Distribution, Complaints, and Product Recall – Covers complaint handling, deviation management, and recall procedures.
Quality of Biotechnological Products – Focuses on regulatory and quality aspects of biotech and biologic products.
Pharmaceutical Quality System (PQS) – Based on ICH Q10, ensures a robust and sustainable quality framework.

5W 1H – Teaches the problem-solving approach of What, Why, Where, When, Who, and How for root cause analysis.
System Validation (GAMP 5) – Covers risk-based validation of computerized systems as per ISPE GAMP 5 guidelines.
Validation and Qualification Training – Covers lifecycle approaches for facility, equipment, and process qualification.
Facility, Equipment, Process, and Analytical Method Validation – Explains validation strategies ensuring systems are fit for intended use.
Computer Systems Validation (CSV) – Provides guidance on validating computerized systems to meet 21 CFR Part 11 and GAMP 5 requirements.
Good Documentation Practices – Highlights GDP principles to ensure data integrity, traceability, and compliance.
Periodic Reviews – Explains the methodology of scheduled system and process evaluations for ongoing compliance.
Equipment Calibration – Explains proper calibration practices for reliable and compliant equipment performance.
HVAC – Provides understanding of HVAC systems, cleanroom classifications, and environmental control.

Soft Skills – Enhances communication, teamwork, and interpersonal effectiveness for workplace success.
Behavioral Skills – Focuses on positive work habits, emotional intelligence, and professional conduct.
Self-Development – Encourages personal growth, time management, and productivity improvement.
Email Etiquette – Teaches professional communication through structured and effective email writing.
Representing Self and Company – Develops confidence and professionalism in corporate interactions.