ISO 9001- Quality management system
ICH Q9- Quality risks management
GMP –Good manufacturing practices
ISO 14001- Environmental management system
ISO 31000 –Risks Management system
OHSAS 18001- Occupational health and safety management system
USFDA/MHRA/WHO GMP : Consultancy/Training/Audits
ISO 10002- Quality management- Customer Satisfaction- Guidelines for Complaints handling in organizations
Internal Audits- ISO 9001
A Three Days Training Programme on Internal Audits include Training on Auditing concepts, methodologies, auditing skills, development of audit checklists; objective type questions on various clauses followed by field audits and examination and release of training certificate.
ISO 31000 Risks Management System
Risks management system aims to identify risks faced by the organization in the environment it operates. A 3 days training programme focuses on objectives, concepts, objectives, methodologies, various kinds of risks and their relationship with the business goals of the organization and how to plan,control and review significant risks.
Handling of Customer Complaints and Measurement of Customer Satisfaction
Prompt and satisfactory resolution of customer complaints is one of the key objectives of all organizations. Each organization always to measure and improve the level of customer satisfaction. A training programme of 3 days duration based on ISO 10002-Quality Management- Customer Satisfaction- Guidelines for Complaints Handling in Organization shall focus on multiple aspects of customer complaints resolution processes and analysis of internal data plus feedback systems for measuring and improving customer satisfaction.
DQ IQ OQ PQ -Qualification of the Equipments
DQ,IQ,OQ,PQ Design qualification, installation qualification, operating qualification and performance qualification of equipments and systems are very critical requirements for API and pharmaceuticals manufacturing. A two days training programme focusses on concepts, definitions, protocols and methodologies for qualifications of equipments and systems and case studies.
Cleaning and Process Validation
For APIs, pharmaceutical formulations and processed foods, cleaning validation and process validation fundamental requirements. Inadequate cleaning and process validation ensure quality risks and potential regulatory non compliances risks. A 2-3 days training programme on cleaning validation and process validation discusses all aspects of validations including protocols, SOPs, formats, plans, under various conditions of same products,product change over, equipment idle conditions, expired cleaning frequencies, product failures etc and ensuring the cleaning and process validations are as per approved GMP guidelines.
Statistical Quality Control ( SQC) and Statistical Process Control (SPC)
The growth and review of an organization depends on the Quality of Its Management Information Systems Reports and the use of statistical quality control and statistical process control methods. A Three Days training programme on Statistical Quality Control and Statistical Process Control can be planned and organized as per customized needs of the organization. The tools like graphs, Gantt Chart, sampling methods, Delphi method, trend analysis, root cause analysis, risks analysis, control chart and process capability studies; the use of check sheets etc. shall be part of the training provided with a focus on the use of internal data for case studies during training.
Training on ICH Q9
ICH Q9 are established Quality risks management system for active pharmaceutical ingredients and pharmaceutical formulations. This is a preventive management system. A three days training programme shall detail on quality risks relating equipments, systems, utilities, concepts and definitions, how to identify risks, prioritize risks and suggest a preventive actions for bringing permanent changes in the systems. Identification of Quality risks methods shall be elaborated with suitable case studies of the products, processes and systems of the organization.
Training on ICH Q7
ICH Q7 are comprehensive guiding document - Good manufacturing practice guide for active pharmaceutical ingredients. A 3 days training programme shall focus on concepts, quality management, personnel, buildings and premises, process equipment, documentation and records, materials management, production and in process controls, out of specifications, change control, packaging and identification labelling of APIs and intermediates, storage and distribution, laboratory controls,validation, rejection and re use of materials, complaints, recalls, contract manufacturing including laboratories and other related aspects. Powerpoint slides, handouts and case studies shall be done.
Software Validation as per CFR 21
Software and related hardware namely DCS, PLC etc and softwares- mother software and application software need thorough design, installation and operation and validation. A two days training programme shall discuss several aspects relating software validation as per regulatory requirements with examples of checklists, DQ,IQ,OQ and PQ of software with password management, user log book, change controls, calibrations, training and competence aspects with contents of the software validation reports.