Starting from the presentation of the most significant failures in the data integrity area, it will be shown the expectations of the regulatory agencies on a compliant data life cycle. The new release of GAMP5 will be analysed, focusing the attention on the new sections, and changing. Moreover, the Self-assessment techniques will be presented to properly identify the compliance level of GxP processes and data handled by systems, providing examples of gaps and related mitigation and corrective actions. Finally, best practices of validation will be explained by presenting best cases of systems implementation exploring the opportunities that digital technologies can offer to ensure a fully compliance of data management.
Getting the opportunities of digital transformation solutions for improving the manufacturing operations in Life Science area and ensuring a full Data Integrity compliance. Realizing opportunities from a digital transformation requires an overall strategy which requires a strong awareness on Data Integrity requirements.
Key points of the training
- The object of the course is to make a clear understanding on the current best practices in the interpretation of rules regarding the handling of GxP data (FDA, EU cGMP, MHRA, PIC/S). The course will go through the new revised version of GAMP5 on Validation of computerized systems. It will be shown processes and procedures for understanding the data life cycle in different business environments. Finally, it will be shown the link between data integrity controls of a GxP process and the validation of computerized systems in the same business process. The course will provide key elements to enable the implementation of the data integrity requirements within your organization, supporting the internal digitalization programs.
9:30 am – 12:30 am MORNING SESSION
2:00 pm – 5:00 pm AFTERNOON SESSION
Times are UTC +1 (Rome time)
• Recent Warning Letters: overview of inspector finding on data management
• Regulatory Expectations: analysis of PIC/S, FDA, MHRA guidelines
• Inspection Trends: latest trends on Data Integrity
• Compliance Assessment: Systems, Procedures and Awareness
• SW Validation: focus on GAMP5 revised version
• Data Integrity Solutions and Digital transformation
QA – Manager and Specialist, QC – Manager and Specialist, Validation Manager and Specialist, Production Manager, IT Manager, Digital Innovation Manager.
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 firstname.lastname@example.org 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 email@example.com. 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.
Project Manager Data Integrity and Systems Compliance & CSV Head at C&P Engineering
Degree in chemistry at the University of Florence, PhD in chemistry at the C.E.R.M. institute, Florence. He spent three years in the academic world as researcher, applying the NMR techniques to biomolecules study. Since 2010, He has been working as Senior Validation Consultant and Validation Project Manager in consultant companies with expertise on Computer System Validation and compliance to 21 CFR Part 11 and EU cGMP Annex 11. In over 15 years of experience, He has managed the validation process for the Computerised Systems used in the Life Science environment (e.g., ERP, MES, LIMS, LAS, PCS) and He has supported the implementation of Quality Systems for the IT governance. He got expertise on the management of GxP Data, focusing on the Data Governance Life Cycle in regulated environments. In this frame, He has managed hundreds validation projects worldwide for the biggest pharmaceutical companies. Currently, He operates at C&P Engineering s.r.l. as the head of CSV business unit.
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