Pharma Lead Auditor Certification (Internal, External and Supplier Audits)

A practical, pharma-focused auditor certification course for professionals who are required to plan, conduct, document and follow up internal, external and supplier audits in the pharmaceutical industry.

Unlike general auditor courses, this training is built specifically around the real audit environment of pharma - including GMP, GDP, API manufacturers, finished product manufacturers, QC laboratories and contract service providers.

The course provides participants with practical tools, audit techniques and pharma-relevant examples, based on ISO 19011:2018 and applicable regulatory expectations.

When?     21.6.2026 + 15.6.2026         |   9:00-16:00

Where?   Gstudy Training Center , Haifa 

Why This Course?

• >> Have you attended auditor training where all the examples came from medical devices or other industries?
• >> Are you expected to audit API suppliers, QC laboratories, GDP service providers or pharmaceutical manufacturers - but are not sure what to focus on?
• >> Do you want to learn from professionals who have actually conducted dozens of GMP, GDP and API audits in Israel and internationally?

This course was designed to close exactly that gap.

Until now, there has been a clear need for a dedicated auditor qualification course that speaks the language of pharma - with relevant examples, practical exercises and audit tools that reflect real pharmaceutical quality and compliance challenges.

What Makes This Course Unique?

This course is 100% pharma-focused, with dedicated emphasis on supplier audits, including API manufacturers, finished product manufacturers, QC and contract laboratories, and storage and distribution service providers.

The course is taught by experienced auditors with extensive hands-on experience in GMP, GDP and API audits in Israel and abroad.

The training includes live exercises and simulations, including how to ask challenging audit questions, how to document findings professionally, how to classify audit observations, and how to manage gaps identified during audits of international suppliers.

The course is based on relevant regulatory expectations and on ISO 19011:2018 for auditing management systems.

Who Should Attend?

This course is intended for:

• QA, QC, RA and Validation professionals in the pharmaceutical industry
• Managers and team members required to conduct supplier audits
• Professionals involved in audits of API manufacturers, finished product manufacturers, QC laboratories and contract service providers
• Professionals conducting or preparing to conduct GMP, GDP or QC laboratory audits
• Anyone looking for an auditor course that is specifically aligned with the pharmaceutical industry

Prerequisites

Participants should have a basic understanding of GMP principles and pharmaceutical quality systems.

Minimum experience of 1-2 years in pharmaceutical quality assurance or a related field is recommended.

About the Lead Tutor

Iris Shamir, M.Sc.
VP Pharma Quality and Medical Devices at Gsap

Iris is a former GMP inspector at the Israeli GMP Inspectorate, ISCP, within the Israeli Ministry of Health.

She served as a lead inspector in audits of laboratories, API manufacturers, dry production facilities, semi-solid and liquid dosage form manufacturers, wholesalers and importers. She also participated in inspections of aseptic and sterile processes, biotechnology products and ATMPs.

Iris has more than 25 years of experience in the pharmaceutical and medical device industries, including combination products, with senior roles in quality assurance, quality control and compliance. She has managed large quality organizations, supported multiple manufacturing sites through successful FDA and other regulatory inspections, and conducted dozens of supplier audits of API and finished product manufacturers in India, China, the United States and Europe.