Training on the topic: Handling of OOS investigations
Venue- Hotel Satkar Residency, Thane
Date of Training: July 2022
Number of participant – 20
Number of companies participated – 08
Training on the topic: QMS with focus on Handling / investigations of deviations
Venue- A reputed Pharma (API & formulations) company based in Vadodara
Date of Training: December 2022
Number of participants – 30
Number of companies participated – In-house training at the company’s manufacturing site
Gap analysis in Quality Control (Chemical, instrumentation, and Microbiology labs) from data integrity and systems compliance perspective
Performed in: January 2023
Company – An USFDA / EU approved API company
Number of days of gap analysis: 3 days of 4
Outcome of gap analysis – The gap analysis was completed. Recommendations were given for the improvements in the identified gaps.
Support in EUGMP inspection readiness: Gap analysis in Quality Control and QMS records from data integrity and systems compliance perspective
Performed in:March 2023
Company –An EU registered API company based in Dehradun
Number of days of gap analysis:4 days of 1 consultant / SME
Outcome of gap analysis – The gaps analysis was completed. Recommendations were given for the improvements in the identified gaps. The inspection was successful with few minor observations
Support in USFDA inspection readiness: Training in Quality Control and QA systems
Performed in:April 2023
Company –An USFDA /EU approved API company based in Bangalore
Number of trainings: 3 days of 1 consultant / SME
Outcome of gap analysis – The inspection was successful with few minor observations
Training on the topic: Quality Management Systems and Qualification of GMP trainer
Venue – A reputed Pharma (API & formulations) company based in Bangalore
Date of Training: May 2023 (4 days)
Number of participants – about 120 (total 4 batches)
Number of companies participated – In-house training at the company’s manufacturing site
Training on the topic: Good manufacturing practices.
Training conducted at an Indian Medical device and IVD manufacturing company based in Thane – Mumbai on the topic, “Good manufacturing practices”.
Date of Training: August 2023