Experienced in preparation and handling of International Regulatory audits for example US FDA, MHRA, TPD ( Health Canada ), MCC etc. Training personnel to face International Auditors especially with answering questions, retrieval of documents, presentation of documents, internal audits and responses to audit findings. Conducting Vendor Qualification Audits for our customers both for API’s and Packaging Materials, and conducting FAT for equipment etc.

cGMP training would include entry and gowning procedures, Working as per Sop’s, Cleaning of area, equipment, personnel hygiene, safety, use of personal protection equipment, working as per the quality systems, recording in the BMR & BPR’s, labeling, equipment and process controls. Reporting of any deviations.

The Quality Management System design would include tech transfer, ( plant, HVAC, equipment, process, analytical systems,& cleaning) validation, Supply chain management including vendor qualification, APQR, Internal audits, handling customer complaints, investigations, deviations, OOS, change control

We have a rich experience in the pharma industry in Projects, scale-up technology, tech transfer, ( plant, HVAC, equipment, process, analytical systems,& cleaning) validation, QMS, Supply chain management including vendor qualification, as well as development and manufacturing of SVP’s OSD’s topical preparations, liquids and veterinary products. Technical skills include formulations, as well as process engineering, package development, clinical supplies documentation for the various submissions like ANDA NDA COS etc..