We conduct Custom Trainings depending on customer needs to employees at all levels who are engaged in the manufacture / storage / distribution of Pharmaceutical / Biotech / Medical devices / Ayurvedic & Homoeopathic / Food / Dietary Supplementary Products.
GMP guidelines as per Schedule M, USFDA , Pharmaceutical Inspection Co-operation Scheme ( PIC/S ), WHO and EMEA. Change Management/ Change Control. Deviations, Out of Specifications (OOS), Out of Trend (OOT), Complaints - CAPA, Returns and Recalls, Vendor Qualification, Annual Product Reviews, Batch Review and Batch Release, Stability Studies . Concept of IPQC, Area clearance/ Line clearance etc
Quality assurance unit, protocol for conduct of non clinical testing, control on animal house, report preparation and documentation. CPCSEA guidelines USFDA GLP Regulations (Subpart A to Subpart K), Controlling the GLP inspection process, Documentation, Audit, goals of Laboratory Quality Audit, Audit tools, Future of GLP regulations, relevant ISO and Quality Council of India(QCI) Standards
Three tier documentation, Policy, Procedures and Work instructions, and records (Formats),
How to maintain, retention and retrieval etc. Standard operating procedures (How to write), Master Batch Record, Batch Manufacturing Record, Quality audit plan and reports.
Specification and test procedures, Protocols and reports. Distribution records.
Electronic data handling. Concepts of controlled and uncontrolled documents.
Submission documents for regulators DMFs, as Common Technical Document and Electronic Common Technical Documentation (CTD, eCTD). Concept of regulated and no Developing clinical trial protocols. & Data Integrity
Introduction to GDP, Legal GDP requirements , Principles, Personnel, Documentation, Premises and Equipment, Deliveries to Customers, Returns, Self-Inspection, Provision of information, WHO GDP, USP GDP (Supply chain integrity), relevant CDSCO guidance and ISO standards
Facility Qualification. Qualification of Manufacturing equipment, Analytical instruments, Laboratory equipment. HVAC Validation. Purified Water Validation. Compressed Air Validation, Process Validation, Analytical Method Validation ,Cleaning Validation ,Media fill simulation studies, Validation & Calibration Master Plan, Computer System Validation, Vendor Qualification, ICH, WHO / FDA / EU / PIC/S Guidelines for Validation
Pharmaceutical Chemicals and packaging material Vendor audit, Auditing of Microbiological laboratory, Auditing the manufacturing process, Auditing of Quality Assurance and engineering department ,Pre-approval inspections, Inspection of pharmaceutical manufacturers, Inspection of drug distribution channels, Quality systems requirements for national good manufacturing practice inspectorates, inspection report, model certificate of good manufacturing practices, Root cause analysis, Corrective and Preventive action (CAPA).
Pilot plant & technology transfer & scale up techniques for different dosage forms Pilot plant scale up: Concept, Significance, design, layout of pilot plant, scale up study, operations, large scale manufacturing techniques (formula, equipment, process, stability and quality control) of solids, liquids, semisolid and parenteral dosage forms.