Get 50% off with the coupon code COUPON50Good Auditing Practices
- Thursday
- September
- 18
- 2025
Hitendrakumar Shah Overview:
Auditing is defined as the on-site or off site verification activity, such as inspection or examination, of a process and six systems including quality systems, to ensure compliance to requirements.
An audit can apply to an entire organization or might be specific to a function, process, or production step.
The CGMPs for the 21st Century Initiative steering committee created a Quality System Guidance Development working group (QS working group) to compare the current CGMP regulations, which call for some specific quality management elements, to other existing quality management systems. The QS working group mapped the relationship between CGMP regulations (parts 210 and 211 and the 1978 Preamble to the CGMP regulations 2 ) and various quality system models, such as the Drug Manufacturing Inspections Program (i.e., systems-based inspectional program). The QS working group determined that, although the CGMP regulations do provide great flexibility, they do not incorporate explicitly all of the elements that today constitute most quality management systems.
Why should you Attend:
This training session will help internal auditors and external auditors to upgrade their skills related to the audit.
The training can strengthen the organization internal audit or self-inspection practices
The internal audit or self-inspection will able to identify good quality of observations which will be really helpful to strengthen the compliance on implementation of the CAPA.
Areas Covered in the Session:
- Understanding importance of the topic
- Evaluation of auditing site based on Quality Risk management
- Value added auditing
- How to save the prestigious audit time
- Good practices while auditing facilities for data integrity and data review
- Training and Qualification of staff
- While auditing same site, how to ensure the different audit strategies
- Auditing for regulatory communications in case of serious non-conformity
- Q&A
Who Will Benefit:
- Quality Assurance
- Quality Control
- Pharmaceutical IT compliance
- Global QA
- corporate QA and QC
- IT Personnel working or related to Pharma IT Support
Speaker Profile
Hitendrakumar Shah is a Quality oriented professional with over 23 years of experience in Quality Assurance, Quality Control, Quality engineering, Quality auditor, pharmaceutical regulations and regulatory audit compliance.
The area of expertise is as per the requirement of USFDA, EUGMP, PICS, MHRA, TGA, TPD, ANVISA, WHO & Schedule-M Guidelines.
The key competencies include, Quality Compliance, Supplier Audit, build systems to encourage compliance with the principles of data integrity, computer system validation, Training, Risk assessment, Facing the audits, preparation and review of audit compliance, Qualification & validation, system development for CAPA effectiveness, stability studies & solving preapproval or post approval queries raised by regulatory agencies etc.
Independently handled - Quality assurance and Quality Control department for more than 13 years.
Audits faced- USFDA (8 times), ANVISA, MHRA, MCC, TGA,IDMA excellence, WHO audit, EU regulatory (9 times) , Yemen MOH, Digemid (Peru), Russian Authority audit etc.
Analytical Background: The analytical background includes, physical, chemical, microbiological testing of raw material, finished product & Stability samples. Handled the chromatographic instruments - HPLC, GC, FTIR, UV Visible spectrophotometer, AAS etc.