API supplier audit

This September 14th from 3 PM to 4 PM (CET) — 6 AM to 7 AM (PDT) — 9 AM to 10 PM (ET) join us for a very special free online event!

What will I learn?

In accordance with the pharmaceutical law in force in Poland, as well as the requirements contained in the Regulation on Good Manufacturing Practice, the manufacturer of medicinal products is obliged to carry out audits of suppliers of active substances, both manufacturers and distributors.

The purpose of the audit is to assess whether active substances are manufactured in accordance with the GMP requirements for API and distributed in accordance with the GDP requirements for API. Audits must be carried out regularly at intervals determined according to the risk assessment posed by the active substance and its manufacturer for the quality of the product.
The purpose of the webinar is to present the issues that should be paid special attention to when preparing and conducting an audit for suppliers of active substances, it also shows the possibilities and advantages of outsourcing audits to a third party. It does not, however, present the full GMP requirements for the API.
Hosted by
logo PQE Group + payoff-1

Introducing the Team

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Małgorzata Ciszewska
Speaker

PQE Compliance Executive Consultant

PhD in organic chemistry. Over 10 years of experience in the pharmaceutical environment including over 6 years expirence as GMP Inspector for Polish Authority with extensive knowlegde of European legistative requirements and with experience in auditing companies from the pharmaceutical industry, both in Poland and abroad. Wide knowledge of issues related to manufacturing processes of: active substances (including sterile), sterile and non-sterile medicinal products, medical gases, radiopharmaceuticals; Quality assurance; Quality control; CEPs related procedures and inspections; and Quality defects of medicinal products.
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Przemyslaw Porebski
Moderator

Business Development Manager

Over 6 years of experience in business development and sales of medical devices, sterilization and transportation solutions.
3 years of experience with IVD products.
Wide experience with microbiology, room disinfection, and sterilization (hydrogen peroxide and autoclaves).
Skilled in writing technical documentation for sterilization.
Degree in computer science, specializing in computer systems and networks.
Graduated with an engineering degree in computer science engineering thesis on the validation of computerized systems.