Discover the course
Audits and Auditors 4.0 Working According to GxP
Innovative Approaches to Audit and Challenges for Auditors Working on New Requirements and Emerging Technologies
The rapid technological progress and the widespread of advanced tools for the Life Science sector have brought significant advantages to all operators in the field. These also determine the need for the Auditors, and Quality and Compliance Managers to identify innovative approaches and methodologies.
The extensive use of electronic systems, such as:
- Electronic Health Records (EHR)
- Electronic Data Capture (EDC)
- Electronic Patient Reported Outcomes (ePRO)
- Electronic Trial Master File (eTMF)
as well as the implementation of innovative technological and procedural solutions, such as:
- Vendors hosting Data Bases
- Data Transfer and Data Migration
require Quality Assurance professionals and auditors to adopt new auditing techniques and to delve into regulatory requirements, which have become increasingly complex and stringent (e.g. Data Integrity and GDPR).
So what is the impact on Audits? What is the impact on the set-up and conduction of an Audit? What skills are needed?
During this 2-days training we will address the following topics:
- New regulatory requirements and guidelines
- New auditing methods
- Audits and in-depth investigations
- Quality and Audit Management Systems (ISO 9001: 2015 and ISO 19011: 2018)
- Evolution in the GxPs
- Computer System Validation - Gamp 5
- Good eClinical Practice - Data Integrity
- Risk Assessment for Audit Planning and Preparation
- Systems and Technologies: EHR; EDC: ePRO; eTMF; Hosting
- Auditor 4.0
- Q & A
The final Q&A session will be an integral and most relevant part of the program: in this session the training leader will develop on any doubts and answer specific questions that participants may want to share.
The course will be in Italian
With more than 25 years of experience in the Life Sciences, Daniela is currently the Head of QA GCP & GVP in Fidia Farmaceutici SpA, a Pharmaceutical Company with Headquarters in Abano Terme, Padua, Italy.
In her position, she is responsible for ensuring quality and compliance of the GCP and GVP Quality System implemented at Fidia Farmaceutici.
Before joining Fidia, she has been working, as Vice-President Strategic Account Management & Scientific Director, from July 2014 to December 2018, at seQure Life Sciences srl, a niche service provider of Pharmacovigilance, Quality Assurance and Regulatory Compliance Solutions.
Daniela has an extensive experience in leading and managing GxP Quality Systems within the Pharmaceutical Industry having being working in Sigma Tau industrie farmaceutiche riunite S.p.A (now ALFASIGMA SpA) for more than 20 years, with her last Job Position as Head of Corporate R&D Quality Assurance and her main responsibilities for ensuring:
- Regulatory Compliance
- Effectiveness of the implemented Quality Management System for Corporate R&D Area including Affiliates
- Compliance in GVP, GCP, GLP, GMP and Computer System Validation
- Continuous improvement of the organisation and its processes.
She is qualified as Responsible for Quality Management System (ISO 9001 standards) and as “Lead Auditor”.
She is also qualified as “GVP Lead Auditor” in compliance with EU GVP Module IV (IV.B.3.1.2).
She performed multiple GxP Audits, Compliance Assessments and successfully completed GxP Inspections carried out by EMA, FDA, AIFA, Italian Ministry of Health and other European National Competent Authorities. She is an active member of:
- GIQAR (the Italian Group of Quality Assurance in Research)
- SIMEF (Società Italiana di Medicina Farmaceutica)
- AFI (Associazione Farmaceutici Italiani)
- ISOP (International Society of Pharmacovigilance).
She attended multiple national and international events as speaker, trainer, and chairman.
“La sperimentazione Clinica in Italia” and “Pharmacovigilance Audit Manual” written by Daniela, were published as part of SIMEF (previously SSFA) activity.
Auditor, Quality Assurance, Compliance Manager, Quality Manager.
Basic experience in quality assurance within clinical research is needed.
Knowledge base training, hands-on exercises, case studies discussion.
Via Masaccio 19
20149 – Milano
Melia Milano is perfectly located in the most dynamic and fastest-growing district in Milan, a short walk from CityLife, a new architectural project with a shopping centre and urban garden. The historical city centre of Milan is just 15 minutes away using the nearby subway.
2 minutes walking from the metro station Lotto (M1 red line or M5 violet line)
Milan Linate airport, 12 km from Hotel Melià, is the most closest airport to the city and can be easily reached by car, bus or train
Central Station 6 km, Cadorna Station 3,5 km, Garibaldi Station 4 km
Garage Masaccio (30 mt), Garage Lotto (350 mt), Parcheggio San Siro (300 mt)
In addition to the hotel venue here is some recommended hotels for accommodation in the nearby:
Hotel Oro Blu (at 230 mt)
Hotel Portello (at 450 mt)
Hotel Montebianco (at 270 mt)
Ristorante Pizzeria La Primula, Via Spagnoletto, 19 (11 minutes by walking). Or, in 15 minutes by metro you can reach the historic city center (“Duomo” metro stop) with various restaurants.
At your arrival you will find our Staff at the Welcome Desk to greet and make you feel welcome and as comfortable as possible, providing direction and all information about the meeting, seating, refreshments.
Coffee breaks and lunch will provide a pleasant moment of refreshment. Special care about the food quality, in particular to your dietary needs or preferences, from menus of local products and flavors to vegetarian dishes.
Limited number of participants to encourage networking and discussion.
All our training facilities are safe, healthy, comfortable, aesthetically-pleasing, and accessible. They are able to accommodate the specific space and equipment needs of the training program.
Depending on the seating configuration, the room may accommodate lecture-style instruction or encourage interaction in the form of roundtable discussions. Equipped for audio/visual, Free Wi-Fi to allow everyone to connect with just one click, electric sockets.
All the information necessary for learning during the course is provided. It is recommended to bring your PC to take notes (even directly on the slides provided in PDF format). The environment is important to us and that's why we try to make this meeting an experience of environmental sustainability.
Early Bird: € 1.315,00* (until 17 March 2020)
Ordinary: € 1.545,00*
Freelance - Academy - Public Administration**: € 715,00*
* for Italian companies: +22% VAT
** Early Bird discount not applicable to Freelance - Academy - Public Administration fee
The fee includes: tuitions, teaching materials, lunches and coffee breaks, organizational office assistance, attendance certificate.
Tuesday, March 17, 2020
At the end of the training, you will be able to
Get new auditing techniques and skills to meet present challenges in the field of compliance
Prepare and conduct Systems / Process Audits in which new IT technologies, devices and equipment are used
Verify data integrity in the paper-less systems.