Key Training Areas

GMP / cGMP Trainings

Focus: Implementation and continual improvement of Good Manufacturing Practices as per:

• 1. WHO-GMP (World Health Organization)
• 2. EU-GMP (European Union)
• 3. USFDA cGMP (21 CFR Part 210/211 – United States)
• 4. PIC/S GMP (Pharmaceutical Inspection Co-operation Scheme)

Topics include:

• 1. GMP principles & QMS integration
• 2. GMP documentation control
• 3. GMP deviations and CAPA systems

Data Integrity (DI) Trainings

Focus: Ensuring compliance with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available)

• 1. MHRA GxP Data Integrity Guidelines
• 2. WHO TRS 996 Annex 5
• 3. USFDA Data Integrity Guidance

Topics include:

• 1. Electronic records & audit trails (21 CFR Part 11)
• 2. Risk-based DI assessment
• 3. Investigation of data manipulation

Documentation Management Trainings

Focus: Development, control, and maintenance of GxP-compliant documents, including:

• 1. SOPs (Standard Operating Procedures)
• 2. BMRs/BPRs (Batch Manufacturing/Production Records)
• 3. Validation protocols, reports, and summary documents

Regulatory & Audit Preparedness Trainings

Focus: Preparation for inspections and audits by international regulatory bodies such as:

• 1. USFDA
• 2. EMA
• 3. TGA (Australia)
• 4. WHO PQ
• 5. CDSCO (India)

Topics include:

• 1. Mock audit handling
• 2. 483 & Warning Letter response strategies
• 3. Audit observations trend analysis

Compliance Management Trainings

Focus: Enterprise-wide compliance alignment with GxP (GMP, GLP, GCP), QMS, and risk-based approaches.

Topics include:

• 1. Quality risk management (ICH Q9)
• 2. CAPA system effectiveness
• 3. Self-inspection programs

Advanced cGMP Trainings

Focus: Industry-specific modules tailored to current regulatory expectations, including:

• 1. ICH Guidelines (Q8–Q12)
• 2. Validation lifecycle (Process/Analytical/Cleaning)
• 3. Quality Metrics & Quality Culture

Training Formats Offered

• 1. On-site Classroom Sessions
• 2. Virtual/Online Interactive Workshops
• 3. Customized Department-Specific Programs
• 4. Certification-Based Modular Courses

Who Should Attend?

• 1. QA/QC Professionals
• 2. Regulatory Affairs Executives
• 3. Production & Manufacturing Personnel
• 4. Site Heads and Plant Managers
• 5. Validation & Documentation Teams