K2C invites you to the Workshop "La firma digitale evolve: dalla smartcard al server di firma" that will take place in Milan (5 May) and Rome (12 May), surely interesting for all pharmaceutical companies that want to comply with 21 part 11 regulations on Electronic Record and Signature, and to better know the available technologies on the market. Details

K2C brings to you unique one-day training on 20th November 2009 in Mumbai, on: “Computer System Validation and 21 CFR part 11 Compliance”. All the questions you wanted to ask like “Which computer systems should be validated? How to select a vendor or system? What is an ERP? What is an electronic signature?” and many more will be discussed and answered. Speakers are experts in Computer Systems Validation, IT systems and in EU / US Regulations. We also offer concessional rates for group bookings - see attached brochure and registration form. Details

New FDA office in New Delhi: are you ready for inspections? ...and without advance notice? Are you updated on regulatory trends, inspection techniques and International best practices? Are you aligned with best practices and tools to comply with Computer Validation requirements? K2C promotes "K2Pharma Compliance Forum 2009", a series of events within a program to create oportunities to improve the knowledge about GxP Compliance. The first event have been organizewd in Mumbai on 7-8 May 2009, and will be focused on two very important topics: "Facility Inspection Readiness" and "Computer System Validation". For more information see details below. Details

60th Indian Pharmaceutical Congress will take place in New Delhi from the 12th to 14th December 2008. Michele Gragnani, K2C CEO and Technical Director, has been invited to hold a speech about US and EU regulatory requirements on Computer System Validation and Electronic Record and Signatures. Click below to see more details about the Cogress program. Details

Dear visotor, CPHI India 2008 has been postponed beacause of dramatic events in Mumbai during the same planned date. We wll inform you about next participation of K2C to this or simlar events. Details

IndiaChem is one of more important event in India for Chemical companies. K2C was invited to participate by ICE (Istituto per il Commercio Estero, Italian Trade Commission) and presented its services at the Italian Pavillon. Click below to to have more information on the event. Details

K2C sponsored the Ispe India Conference “QRM and GAMP: a Practical Approach” that has been organized in Mumbai the 21st and 22nd July. Some of the top international experts on Computer System Validation and GAMP Guideline have attended to this conference. K2C consultant Ermanno Bulzicco has delivered a lecture about the application of Risk Management and GAMP methodologies to basic requirement for API production according to ICH standard, giving both information about auditors expectation, consultancy experience and how to cover them. Details

K2C collaborates with University of Florence (Degree in Pharmaceutical Chemistry & Technology, Pharmacy, and Quality Control) organising a series of courses hold by Jacopo Montigiani (K2C CEO and R&D Manager) as adjunct Professor. Click below to view the full program. Details

K2C participated to ISPE India Seminar in Mumbai titled "Investigating and Handling Technical Pharmaceutical Complaints". Click below to view details of the seminar program. Details

K2C sponsored and actively attended the ISPE India Affiliate Seminar "Good Laboratory Practices", hold at Ahmedabad (Gujurat, India) on 24th February. A K2C representative delivered a lecture titled "Assess and Validate Laboratory Computerized Systems: from theory to practice". Details