Internal and External Auditors Certification for Pharmaceutical Industry
Gstudy > Courses and seminars > Internal and External Auditors Certification for Pharmaceutical Industry
Quality Assurance
Audits
Location: Online/Frontal
Starts at: 09:00
Duration: 2 Days
Language: Hebrew
A comprehensive training program designed to provide pharmaceutical quality assurance professionals
with the theoretical knowledge and practical skills required for conducting internal audits and supplier assessment audits.
The course combines regulatory theory, industry examples, and hands-on practice.
When? 08/06/2026 + 15/06/2026 | 9:00-16:00
Where? Gstudy Training Center , Haifa
How will I benefit?
- Acquire theoretical knowledge required for conducting internal audits and supplier assessment audits
- Learn audit phases and processes
- How to prepare to perform an audit
- Write audit reports and classify findings
- Gain specialized focus on API manufacturers audits, laboratory audits, and Storage & Distribution audits (GDP)
Target Audience:
Quality assurance professionals, quality managers, and supplier quality specialists. The course is also suitable for employees and managers from other departments who are planning to conduct internal audits or supplier audits.Basic Requirements
Basic knowledge of GMP principles and pharmaceutical quality system. Minimum 1-2 years experience in pharmaceutical quality assurance or related field recommendedApplicable standards and Guidelines
- ISO 19011:2018 Guidelines for auditing management systems
- EudraLex Volume 4 EU Guidelines for Good Manufacturing Practice
- FDA Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations
- ICH Q7A Good Manufacturing Practice for Active Pharmaceutical Ingredients
- PIC/S Guidance on Classification of GMP Deficiencies
About Iris Shamir, M.Sc.
Former GMP inspector at the Pharmaceutical Inspection Division of the Israeli Ministry of Health’s Institute for Standardization and Control (ISCP). She served as a lead inspector in audits of laboratories, active pharmaceutical ingredient (API) manufacturers, dry production, semi-solid and liquid dosage forms, as well as wholesalers and importers.Iris participated as an inspector in audits of aseptic and sterile processes, biotechnological...
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Registration Information
Early Bird Discount: 30 days in advance
Group Rates: Available for 3+ participants
Corporate Training: Custom programs for 8+ participants
Contact: Gstudy@gsap.co.il