SIMco Pharma Consultancy has ready available modules for trainings and workshop. Also team of Subject Matter Experts (SMEs) are available for preparing on site customized audio and video trainings for people. Our Mission and Moto is to make people knowledgeable and cGMP known people to support pharma industry and contribute growth of industry, themself and nation pride.
Today Data integrity (DI) is one of the serious and very frequent observation of auditors from various regulatory bodies and people are not coming up understanding of consequences. Our SMEs are experts to understand the requirements of client and make customize training module for the issues and bring good understanding of subject to the user and making implementation for CAPA for the same as well as to make realization on peripheral issues too the people were things can go wrong if not attended on time. Our intentions are to give assurance to the client, people working with them shall be good to understand cGMP (Current Good Manufacturing Practices) to make Safe, Effective and Quality product for the patients.
Modules available for the training:
* Data integrity of Microbiology Lab - Under Microscope of Regulators
* Validation of Sterilizer and Dry Heat Sterilizer - What Regulator want to See?
* cGMP / cGxP
* CSV (Computer System Validation) and Data Integrity
* Media Fill - What goes wrong with failure of Media Fill?
* Water System for Pharmaceutical uses - New requirements of EU guidelines
* How to prepare an effective SOP - Workshop with case study
* What USP Chapter 1116 and EU Annex 1 guide for Clean area working?
* Basic GMP / cGxP modules for the beginners in Pharmaceuticals
* Scientific process of interaction with Inspectors during FDA inspection
* Challenges in Analytical Method Transfer
* Good Laboratory Practices
* Schedule M-GMP requirements of Pharmaceutical Products in India
* Essentials of Quality Assurance and Quality Management System
* How to Prevent Data Integrity in Laboratories (QC and Microbiology)
* Quality Metrics an informative tool for compliance
* Handling of Investigations
* Quality Risk Management - A process
* Recent trends of regulatory inspections- Compliance by design
* A fundamental approach to Cleaning Validation
* Data Integrity and Good Documentation Practices
* Effectiveness of CAPA
* Process enhancement through Quality by design
* Handling of Out of Specifications
* An overview on Pharmaceutical Industry
* Computer System Validation- GAMP5 and 21 CFR Part 11/ EU Annexure 11
* Pharmaceutical Water-Generation,Distribution ,Monitoring and Compliance
* Clean Room and HVAC System- As per GMP regulations
* CSV and Data Integrity
* Proficiency Matrix- Skills and Knowledge assessment
