MEDICAL MANUFACTURING

TRANSFERS

Seisa_MedManufacturing_Transfer

Transfers

SEISA has more than 30 years of experience in successful product transfers under regulatory compliance with robust validations. The key to SEISA’s premier track record in transfers has been its ability to provide communication that strikes the right balance between being structured and dynamic. This communication has resulted in more than 30 seamless transfers of single-product lines and entire facilities in the last decade.

The result of SEISA’s efficient transfers has been dependable recurring production that lowers customers’ costs and allows them to focus on newer product lines and/or to continue strategically outsourcing legacy products.

SEISA’s transfer project controlled processes are divided into four manageable phases:

Planning Phase

SEISA works with the customer to create a dynamic and interactive document that details a project schedule with focus on organizing responsibilities and requirements.

Project Transfer

Engineering, supervision, and training experts from the SEISA transfer team travel to customer’s site to begin process transfer, with a focus on an “as-is” from site to site.

Validation / Ramp Up

  • Processes are validated according to customer specification and processed through SEISA’s Standard Operating Procedure
  • Validation tasks, such as IQ, OQ, PPQ, are conducted
  • Training of personnel begins and production begins, with ramp up based on calculated learning curves

Recurring Production

  • SEISA and customer partner to schedule production based on customer’s forecasts and purchase orders
  • Equipment maintenance and calibration is managed through SEISA’s preventive maintenance programs
  • SEISA team programs internal and customer meetings to discuss performance and potential improvements

SEISA’s Shared Commitments to Customers

Regulatory-focused culture: FDA-registered, ISO-certified

Lean initiatives to drive savings and improvements

Scalability to meet any market demand

Seamless customer care communication