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Validation Services › Validation & Training Package

Validation & Training Package

Companies looking to achieve FDA compliance can take advantage of Industrial Technology Systems Ltd’s (ITS) Validation & Training Package – a tailor-made programme designed to meet corporate regulatory needs.

Following a site visit and audit to identify validation and training requirements, ITS will put together a bespoke validation and training package that meets specific company needs and responds to each organisation‘s individual requirements.

Depending on those requirements, the Validation & Training Package may include any of the following services:

• Validation Plans or Master Plans 
• Design Qualification
• Pre-Delivery Testing
• IQ, OQ and PQ
• SOP Writing
• Validation Reports
• GMP Training
• GAMP® 5 Training
• Validation Training
• FDA Audits Training
• SOP Training 

ITS has extensive validation and regulatory compliance experience, working with pharmaceutical, medical device, and food & beverage companies for more than 17 years, on both new and legacy systems.  During this time ITS has been closely involved with the International Society for Pharmaceutical Engineers (ISPE).  We actively participate in a number of ISPE Special Interest Groups (SIGs), and have been associated with updating and producing a number of guides, including Validation of Process Control Systems, Testing of Critical Systems, and Electronic Data Archiving. 

ITS works to the principles and practices of GAMP® guidelines, incorporating all associated regulatory requirements, and making us ideally placed to provide project advice and assistance to pharmaceutical and medical device industry manufacturers, and their suppliers.

ISPE owns the GAMP® trademark http://www.ispe.org/