In the workshop room 1, the first day starts with a workshop by ASSI, on qualification of laboratory equipment according to USP 1058 and data integrity. Then, Oqotech will carry out the workshop ‘Validation of Computerized Systems for pharmaceutical laboratories according to GLP and GAMP 5’. In the afternoon it will be the turn of TDV with ‘Digital Quality, How digital transformation affects the pharmaceutical quality system’.
In parallel, workshop room 2 will start with TELSTAR and the workshops ‘Commissioning and Qualification: From Traditional Approach to Verification Approach (ASTM E 2500)’ and ‘Pharma 4.0. IOT data platform for predictive maintenance’. QTI will develop one entitled ‘Steam in the pharmaceutical industry: Are you ready for the new requirements in pharmaceutical steam quality’. Finally, Azierta will close the first day in this room with the workshop ‘Practical approach to the new regulation of medical devices: critical aspects and resolution of real cases’.
The 16th of April will start in workshop room 1 with Quality By Design and ‘Risk Management 4.0. Practical examples to digitalize the acquired knowledge’. Afterwards, Azierta will talk about ‘Nitrosamines: past, present and future’. And in the afternoon, Asphalion will close with the workshop ‘Review and support of statements under MDR’.
On the other hand, workshop room 2 will start the closing day with the workshop ‘Observations on inspections: let’s tell lies’ by Audinnova. Next, Qualipharma will conduct the workshop entitled ‘Don’t limit your market possibilities: Why not medicines, health products, nutritional supplements, cosmetics,…’. Finally, BEC will give the workshop ‘Are they cosmetics or are they OTC medicines for the USA market? – Regulatory implications’.
Likewise, in the last shift of workshops, the Alkemi room hosts the Diversey workshop entitled ‘BPR new European regulation of biocides. Considerations for the cleaning and disinfection of clean rooms and CIP processes in the pharmaceutical and cosmetics industry’.