Audit and Inspection in the pharmaceutical
- 7-9 May 2024
- Online
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Italian
- 7-9 May 2024
- Online
-
-
Italiano
-
Training overview
The training course “Audit and Inspection in the pharmaceutical” aims to provide participants with useful tools to manage the entire audit lifecycle. In fact, the GMP Audit represents the main tool for the evaluation of a company’s compliance status and for an effective verification and improvement of the Quality Management System. There are two types of Audits: Internal and External, each with a specific purpose; the first, mandated and functional to ascertain and improve the application of GMP within the corporate organization, the second, deputed to the selection, qualification, and maintenance of a specific supplier of goods and/or services. Added to this is the Regulatory Audit or Inspection, carried out by Regulatory Bodies (FDA, AIFA, Ministries etc.) and aimed at maintaining or revoking the company’s GMP certification status for placing products on the market (MAH). The professional figure within the company’s Quality System who is designated to preside over these two types of audits is the Auditor, who represents a key figure in the Quality System.
The training course “Audit and Inspection in the pharmaceutical” will also explain you the inspector’s point of view and the critical aspects for a successful inspection outcome.
Would you like to participate, but you’re not available on this date?
The course will be provided again:
- May 6th and 13th 2025
(*) Contact us via email or phone to enroll.
Interested in Quality & Process training?
Enroll in 3 courses and you’ll get a 15% discount*, while choosing 5 courses will grant you a 20% discount*!
Choose among these titles:
- Technology Transfer nel settore Farmaceutico – English training
- Ispezioni e Audit nel Farmaceutico
- Gestione dei risultati OOS e OOE/OOT
- Risk Analysis nel Farmaceutico
- Il Monitoraggio Ambientale nel Settore Farmaceutico
- Le Good Distribution Practices (GDP)
- La Convalida Analitica secondo ICH Q2
- Metodi Statistici per il Controllo Qualità
- APR, PQR e CAPA System
- Il Campionamento Ambito Farmaceutico
- Qualifica, Convalida di Processo e Cleaning Validation
- Inspection Readiness Documentale
- Investigational Medicinal Products: Aggiornamenti EU sugli IMPS
- La Convalida dei Metodi Microbiologici
- Studi di Stabilità nello Sviluppo Farmaceutico
- Ispezioni e Audit al Laboratorio QC Microbiologia
- RABS e Isolatori nella Produzione dei Farmaci Sterili
- Le Deviazioni Microbiologiche: Come Gestirle?
- Qualified Person: Giornate di Formazione
- Il Controllo Microbiologico nel Settore Farmaceutico
- Pharmaceutical Risk Assessment – English training
(*) discounts apply to the full prices of the courses and cannot be combined with other promotions.
The promotion is limited to enrolling the same person in 3 or 5 courses selected from those offered.
Key points of the training
- Understand the main regulatory requirements that underlie Auditing activities
- Learn the Audit Lifecycle process: objectives, tools and applications for an effective Audit system
- Learn the key points to inspect during an audit to various systems
- Regulatory inspections: trends and the inspector's point of view
09:30 – 12:30 MORNING SESSION
14:00 – 17:00 AFTERNOON SESSION
Program
The course will be carried out through live lectures. Practical examples will be showcased, providing delegates with real life examples to be applied in their daily job life.
For online trainings the access link will be sent 2-3 days before the start of the training.
5% discount for registrations within 1 month before the start of the training, 10% discount for registrations within 2 months before the start of the training. VAT not included. Please inquire for discounts for multiple registrations. Discounts are not cumulative.
Cancellation terms
In order to cancel enrolment to an event, please email info@pharmaeducationcenter.it within 2 weeks before the starting date of the event. Once this term will be expired, the entire fee will be charged.
Participant replacement
It is possible to replace a participant attendance without additional cost, simply by contacting info@pharmaeducationcenter.it. It is asked to notify the participant replacement request within 5 days before the starting date of the course/event, specifying the full name and surname of the enrolled participant as well as the full name and surname of the substitute.
Training cancellation
If the minimum number of participants is not reached, Pharma Education Center reserves the right to cancel or schedule the event for another date. Formal communication will be given within 5 days before the event date. In this case Pharma Education Center will refund the registration fee in full and without additional charges. Alternatively, the participant can request a spendable coupon for participating in another PEC event scheduled in the current year.
Speakers
Lucia Costanzo
GMP Expert, PHARMA D&S
Graduated in Pharmaceutical Chemistry and Technology in 1992 at the University of Siena, she has gained over 16 years of experience within the multinational GlaxoSmithKline, having the opportunity to cover various roles over time such as: Batch release manager in Quality Assurance, head of the chemical analysis/stability laboratory, head of the injectables production department, head of internal auditing activities. Over the years she has had the opportunity to deal with numerous inspections by regulatory bodies (AIFA, FDA, Brazil, China, Japan). She is currently involved in GMP Training activities within Pharma D&S and PEC.
Fernanda Ferrazin
Ex- GMP Senior Inspector
Graduated in Pharmacy in 1978 at the University of Rome La Sapienza, she has gained extensive experience as a GMP Inspector and as a manager in the public sector, first at the Ministry of Health where she served from 1984 to 2004, and subsequently at the Agency Italiana del Farmaco, established in 2004. From 2009 to 2013 she dealt with the safety of medicinal products (as Manager of the AIFA Pharmacovigilance Office and as alternate member of the PRAC – Pharmacovigilance Risk Assessment Committee of the European Medicines Agency EMA in London) and, from 2013 to 2015, she verified the regulatory obligations due for the updating of Registration dossiers and CTDs of medicines by MAH Companies, in particular in cases of withdrawal of GMP certifications of API and semi-finished / finished products production workshops.
Angela Petrigliano
Operational Manager Process & Quality
Graduated in 1992 in Pharmaceutical Chemistry and Technology at the University of Siena, she has 30 years of professional experience in pharmaceutical companies and in the world of pharmaceutical consultancy. She began her career in 1992 in the Research and Development of the Technobiochip. Subsequently she worked in Quality Assurance at A. Menarini Industrie Farmaceutiche Riunite (Florence) and in the Corporate Quality Department of the Menarini Group from 1996 to 2000 where she gained experience in the different sectors of Quality Assurance and in Operations. From 2000 to 2009 she worked at Bayer Biologicals (Rosia – SI) where she assumed roles of increasing responsibility up to Plant Manager and Head of Operations. From 2009 to 2011 she was Qualified Person and Plant Manager at Galenica Senese. Since 2012 she has been Operations Manager Process & Quality at Pharma D&S; she is also involved in training activities within Pharma Education Center.
Register now
1400€
Training materials available for attendees
Certificate of attendance
Senior trainers with hands-on experience
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