Quality
Auditor Qualification / GMP Auditor, Lead Auditor Training
20th and 21st August, Dubai
Auditing is a critical function within a pharmaceutical company. It provides management with information about how effectively the company controls the quality of their processes and products. Auditors must perform their jobs competently to ensure their company’s compliance with pharmaceutical USFDA GMP regulations and other quality standards like ICH Q10. This Auditor Qualification / GMP Auditor, Lead Auditor Training is specifically designed to address the challenges of GMP auditing for the pharmaceutical industry and present the basic competencies required to effectively perform the auditor's assigned responsibilities.
Date : 20th and 21st August, 2024
Time : 9am to 5pm
Venue : Novotel Bur Dubai
Registration Fee : 2,000 AED
Early Bird Registration Fee : 1700 AED, registartion should be compeleted on or before 31st July
Training Highlights:
Training approach will be more practical using video clips and audio clips of actual audits.
Participants will be expected to actively involve in Group Discussions
Case Studies
Practical exercises/ demonstration for most of the training topics will be included.
This training and certificate is not associated with registered bodies, however our training will help you to pass any audit qualifying exam without hurdle.
Please send your name, company designation, contact number to admin@scientiabio.com to register and call us at +91 804169 2453 / +91 9945318216 for any query or registration help.
Know us more at www.scientiabio.com
Please send the filled up registration form to admin@scientiabio.com to register and call us or whatsapp at +91 9945318216 / +91 804169 2453 for any query or registration help.
Training agenda:
Day 1
Regulatory expectations for Internal audits,
Principles of Auditing - ISO 19011
Risk based approach for audits
Requirements for Internal audits
Importance of self-Inspection
Auditing for continuous Quality improvements – Case studies
What Makes a good Auditor – 5 Ps
How you roll out an effective Internal Audit and Vendor Audit - system/ Program - Top 10 tips
Regulatory citations on audits
Q&A Session on topics discussed
Skills and Knowledge requirements
Audit Behaviours
Questioning methods
Six Key steps and Auditing Process
Audit Preparation
Developing checklist
Conducting the Opening meeting,
Audit Performance – during site rounds
Data review, data gathering, identifying good practices and also non conformances
Q&A Session on topics discussed
Day 2
Audit Performance
How to do document reviews
How to identifying Data Integrity issues during audits
Case studies – Identify non conformances during a mock audit or identify non-conformances in Photographs/your own site
Q&A Session on topics discussed
Conducting a closing meeting
Writing an audit report
Reviewing the responses and CAPAs shared
Close out of audit.
Questions/Feedback/ Close out of the training session
About the trainer Ms Vasundhara Iyengar
Ms Vasundhara is result-oriented Pharmaceutical Quality professional consultant, Auditor, Trainer, Lean laboratory consultant, with 30+ years of experience in pharmaceutical companies.
Previously she was with GSK India as Site Quality Head (General Manager), before that she was with Astra Zeneca as Site Quality Director.
She had led Quality teams comprising of Quality assurance, Quality Control, Analytical Development, QMS implementation and compliance, Auditing, Training, Site Quality Remediation, Corporate Quality, Risk Management, External Quality (Contract Manufacturing and API supplier management), Regulatory compliance, Product Life cycle management (Process Validation).
Experienced in Laboratory designing and setting up of laboratory and QMS in Green Field Projects.
An IRCA Certified Global Quality/GMP Auditor, with valuable supplier global auditing experience in APIs, Formulations, excipient, chemical, Packing material industries (manufacturing & packaging).
Certified trainer, conducted training to global auditors, Asia PAC sites and Pharmaceutical Companies.
Have conducted Audits across Asia Pac (India, China, Singapore, Indonesia, South Korea, Japan, Australia and New Zealand) and Europe.
ScientiaBio has trained more than 500 pharma professionals in lead auditor training.
Feedback of our virtual LIVE GMP Auditor / Lead Auditor training
Very well explained auditing aspects and GMP elements with real time examples and case study. Tremendous knowledge about the regulatory and statutory requirements. Very good reference/study materials shared for the course - Mr Ratish Acharya, Head of Function - Quality Assurance, IDRS Labs
The learning material was useful and easy to understand. The idea - to have multiple short sessions is also very nice, because the materials are divided and easier perceived each day. I also received answers to the important questions, that I had. The examples, which the lector was giving, were really helpful. Thank you for your hard work! - Viktoriia, Auditor of Quality Systems, Yuria Pharm
1. Provide guidance for career growth and professional development opportunities
2. Good to understand with practical examples.
3. Clear all the queries raised during the session.
4. Elaborative & knowledgeable session
------ Sagar, Assistant Manager, Zoetis Pharma
The content and examples from mentor so useful and easily comprehensive. Explanation so deeply. - Huynh Loan, Ofi Vietnam
Please send your name, company designation, contact number to admin@scientiabio.com to register and call us or whatsapp us at +91 9945318216 / +91 804169 2453 for any query or registration help.
Know us more at www.scientiabio.com
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