Written by Good Clinical Laboratory Practices (GCLP)Workshop on International Standards ISO 15189:2022 from 23rd – 25th March 2023
GCLP outline the basic principles and procedures to be followed by clinical/diagnostic laboratories involved in patient care or clinical research so as to provide highly reliable, reproducible and auditable results, which contribute to good patient care and promote a positive attitude from a patient’s perspective.
This GCLP workshop is designed to offer comprehensive guidance for those who are implementing GCLP/ISO 15189:2022 in their medical laboratories and a special session on Quality System and QA/QC in Molecularbiology Laboratory Testing included in this workshop
Only those from accredited (NABL/NABH) medical laboratories or preparing for accreditation or planning to take up a career in medical laboratory accreditation with ISO 15189:2012/2022 and Clinical Research Organization (CRO)’s laboratories (human clinical trials), are encouraged to participate in this workshop
Learning Objectives:
- Basic principles of the GCLP and their relation to patient care services or clinical research.
- Implementing GCLP essentials to establish a quality system and its maintenance.
- Gaps between ISO 15189:2012 and ISO 15189:2022, and implementing new standards
Workshop Scope:
- Overview and essentials of ISO 15189:2012.
- Overview and essentials of new standard – ISO 15189:2022.
- Overview and essentials of NABL-112 guidelines document.
- Overview and essentials of ICMR-GCLP 2021 guidelines.
- Special reference to the following key components:
o Quality System Essentials (QSEs).
o Establishment, management and monitoring of quality system.
o Quality indicators and continual improvement.
o Issues with EQAS/PT, Issues with facility operation.
o Internal Quality Audit (IQA) – common NCs and its closures.
o Lab accreditation associated challenges and overcoming the challenges.
o Biosafety and infection control.
o Quality system and basic requirements in Molecularbiology Laboratory Testing/Assays – International standard.
Workshop activities include didactic lectures, interactive sessions, group discussions/exercises and case studies. The faculties from national and international settings will facilitate the program.
Registration:
The participants can register for the program by paying Rs. 3,500/- and the payment can be done by scanning via net-banking or GooglePay to the following bank account: Account No. 1248135000009037, Account Name: SDC Microbiology CME, Bank: Karur Vysya Bank, IFSC Code: KVBL0001248, Branch: PH Road, Chennai-600077
The workshop is restricted to 60 slots and the registration will be done on “first come-first served basis”. For online registration, the following link has to be used: https://forms.gle/yASYBXXqKnp7NmdN8. Out station participants need to book accommodation on their own
Venue: Decennial Hall, Saveetha Dental College and Hospitals Campus, Saveetha Institute of Medical and Technical Sciences (SIMATS), Deemed University, Chennai-600077.
Contact: Dr. Pachamuthu Balakrishnan, Department of Microbiology, Centre for Infectious Diseases, Saveetha Dental College and Hospitals, Saveetha Institute of Medical and Technical Sciences (SIMATS), Deemed University, Chennai-600077. WhatsApp/Mobile: 7667444221, Email: GCLPSAVEETHA@gmail.com