Your Trusted Partners for Quality Assurance and Regulatory Services…
SPECIALISED PHARMACEUTICAL TRAINING PROGRAMS:
  • Pharmaceutical Quality Management System (PQMS) - This programme is aimed at providing complete understanding of the Quality concepts that ensure the delivery of a Quality Product from a manufacturing facility. This will cover the selection criteria of starting materials (Packaging Materials and ingredients/components of the Formulation), testing and specifications for the starting Packaging & ingredients materials, Selection of a suitable Manufacturing Process, Process controls and its validation, Testing method and specification for In-Process and Finished Product by the Quality control ( Method suitability, Selection & Validation status), suitable Packaging & Storage of the product ( during manufacturing and in the Ware house), Maintenance of required quality of the environment in the manufacturing area, Training of Personnel involved in the manufacturing Process, SOPs for performing a particular operation during the manufacturing, storage and testing of the product.
  • Product Development - This programme is aimed at providing complete over view of the activities involved during the development of a new product. This includes concepts like, how new drugs are developed, how drugs are different from chemicals, Pre-formulation studies, Analytical method development , Pre-clinical studies, stability studies, Manufacturing process design and development, BA/BE Studies, clinical studies ( including establishing safety & effectiveness of the New product before marketing), Post-marketing studies and Pharmacovigilance, Intellectual property.
  • cGMP – This programme is aimed at providing the understanding of importance of cGMP in pharmaceutical product manufacture and marketing. This includes complete overview of the fundamental cGMP concepts which is mandatory to follow to put a product into the market. This covers the complete manufacturing process and its relevance in achieving the cGMP compliance.
  • Regulatory Affairs – This program is aimed at providing the relevance of Regulatory Affairs in pharmaceutical product development and marketing. This will cover the role of various regulatory bodies in controlling the quality of a pharmaceutical product available in the market for human consumption, like ICH, USFDA, MHRA, etc., details required by the regulatory authorities about the product, manufacturer of the starting material ( API), Primary Packaging materials, Finished product, label, various declarations from the manufacturer, fee for the registration of products ,etc. This also covers the discussion on various major regulatory authorities across the globe.
  • Training - Training to your people on any Quality topic as per your Training Calendar and Training Matter. This service will save your valuable Resources/Time towards Regulatory Compliance towards the Employee Training requirements. PQMS can take up Annual / Long-Term Contract for this Service.
  • Site Quality Audit - This programme will cover the significance of site audit in achieving compliance towards the prescribed quality of a pharmaceutical product. The site audit is a mechanism to ensure Quality of a manufactured batch at a site. This will include the audit of critical manufacturing functions performed at a site/manufacturing facility like, Storage of Ingredients, Finished Product & Packaging components, Manufacturing Process and controls, In-process and Finished product testing/Release by Quality control, Stability Programme, Market complaint for any other product manufactured at that site, Personnel Training, QMS like SOPs for various critical functions.
What's New
CRQA is looking for
qualified and Independent
Pharmacvovigilance Auditor
- experience essential in
Pharmacovigilance Audits.
Interested Professionals
may apply to bd@crqa.in
CRQA is looking for
qualified and Independent
Pharmacvovigilance Auditor
- experience essential in
Pharmacovigilance Audits.
Interested Professionals
may apply to bd@crqa.in
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