The figure of the Qualified Person in API and Finished Product Pharmaceutical companies has assumed an increasingly central role over the years as the main guarantor of Quality, Safety and Product Compliance with GMP and National and European Regulations. In this figure reside multiple responsibilities and obligations that presuppose a good knowledge of regulatory and GMP requirements and adequate process and product expertise. This two days training for the qualified Person, divided by topics, aim to deliver to the Qualified Person the basic points on regulations and GMP and, based on the extensive experience of the lecturers, suggest operational tools (including Audit, Supplier Qualification, CCS, RQM, CAPA, PQR) on how to “supervise ” and ensure that the company Quality System is effective and guarantees the release of safe and in compliance products.
Key points of the training
- Focus on key GMP Reference Standards and latest updates
- Understanding Role and Responsibilities of the QP figure
- Understanding the tools for overseeing processes and products: CCS-QRM-RCA-CAPA- PQR
- Understanding the critical points of Batch Review/Release
09:30 – 12:30 MORNING SESSION
14:00 – 17:00 AFTERNOON SESSION
Day 1 – Speaker Leonardo Gabrieli
- Relevant national and EU regulations
- Role and Responsibilities of the QP, Annex 16
- Regulatory and compliance aspects
- Relationship between GMP and GDP
- Aspects pertaining to the Anti-Falsification Directive
- Good Documentation Practice & Data Integrity – Q&A-discussion
- API supplier/excipient qualification
- Technical agreements
- Complaints and Recall
- Final Q&A-discussion
Day 2 – Speaker Angela Petrigliano
- Batch Record Review /Release/ Batch Disposition.
- Deviations/MDD (Microbial data deviation)
- RCA / CAPA
- Change management
- Quality Risk management
- Essential and nonessential changes
- Process Validation
- Product Quality Review
- Management review
- Contamination Control Strategy -CCS
- Final Q&A-discussion
The course has been designed for the figure of the novice or experienced Qualified Person who needs an update on the latest regulatory news and trend regulators.
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.
In order to cancel enrolment to an event, please email email@example.com within 2 weeks before the starting date of the event. Once this term will be expired, the entire fee will be charged.
It is possible to replace a participant attendance without additional cost, simply by contacting firstname.lastname@example.org. 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.
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.
Operations 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.
Pharmaceutical Consultant, former Quality &Regulatory Director Teva Italia
He has thirty years of experience in the pharmaceutical sector, with responsibility in Production, Quality Control, Quality Assurance and as a Qualified Person in multinational, manufacturing and commercial companies. He has delved into all the elements involved in the manufacture and control of medicines, with particular attention to the requirements of the GMP/GDP directives, laws and guidelines, issued in the international pharmaceutical sector. He has participated as an expert in various Courses, Symposia and University Masters, provided multiple training events on GMP/GDP and carried out business consultancy for the verification and setting up of an effective Pharmaceutical Quality System. Thanks to his qualifications as Quality System Manager and Quality Auditor, he has carried out hundreds of inspections on behalf of a Certification body for assessments of compliance with ISO 9001 standards and Notification for Medical Devices. He collaborates with AFI in implementing the annual Meeting of Qualified Persons.
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