Introduzione
Compliance with Good Manufacturing Practices (GMP) is crucial for ensuring the safety, efficacy, and quality of pharmaceutical products, thereby protecting the health and well-being of the end patient. Adhering to these standards helps to maintain patient trust and ensures that the medications they receive are safe and effective.
Regulatory inspections play a vital role in ensuring compliance with GMP. They form the basis for the so-called 'licence to operate', i.e., the 'authorization' that regulatory authorities grant to manufacturing plants, allowing them to manufacture, control, release, and distribute pharmaceutical products. Dealing with a GMP inspection by a regulatory authority can be a tiring, difficult, and frustrating experience. The difficulties are even greater when the inspection has to be handled in another language (typically English) and with possible cultural barriers. To make the inspection a manageable and fulfilling, albeit tiring, experience requires good preparation, the ability to organise and represent the company, the quality management system, and the production facilities to the best of one's ability.
– Legal and regulatory basis for an inspection
– Types of inspection (e.g. PAI vs. GMP routines, scheduled vs. unscheduled)
– Approaches to inspections
– Inspection trends/recent observations and Hot Topics
– Cultural and language challenges
– Inspection techniques
– Inspection preparation
– The role of management
– Managing the inspection
- Roles and responsibilities
- What to do and what to avoid
- Activities
– Possible inspection outcomes (classification of observations, NAI, VAI, WL)
– What to do after the inspection
Quality Assurance Managers, Qualified Persons, Compliance Managers, but also all personnel (e.g. Quality Control, Production, Engineering) who have to prepare for, manage and respond to a regulatory inspection in a pharmaceutical plant.
The online workshop will be a mixture of theoretic presentations, case studies and practical examples.
Docente/i
Antonella Ursini
Antonella has over 30 years’ experience in pharmaceutical research and development, with expertise in leading and managing multidisciplinary teams at all stages of drug development.
Her background is in organic chemistry and pharmaceuticals.
After graduating, she joined GLAXO and worked on the synthesis of new molecules. She then moved to preclinical development at GlaxoSmithKline, where she was responsible for the Business Operations group, dealing with GMP compliance, quality and process optimisation using Lean Six Sigma techniques.
Before joining seQure in 2017, she held the position of Quality Director for APTUIT’s research and manufacturing sites in Verona and Oxford.
Ceri Thornley
Ceri has worked within the pharmaceutical industry since 2003, following graduation from university with an honors degree in Biomedical Science. Her first role was within QC Microbiology followed by various Quality Assurance roles within different types of manufacturing facilities across different product formats. Fast forward 21 years and she is currently the GMP & GLP Associate Director at Arithmos, as well as a trainee Qualified Person where she supports a number of clients through audits and consultancy. Of the GxPs, her passion is all things manufacturing!
This online training consists of 1 module:
25 November 2024 from 2:00 pm to 6:00 pm CET
Some days before the online training you will receive all details about the connection.
The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
Early Bird: € 515,00* until 04/11/2024
Ordinary: € 645,00*
Freelance – Individual – Academy – Public Administration**: € 435,00*
*for Italian companies: +22% VAT
**Early Bird discount not applicable to Freelance – Individual – Academy – Public Administration fee
The fee includes: tuition, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
Barbara Rossi
Training & Quality Manager
Cosa saprai fare dopo il corso
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.
