Center Physician

Ensure the proper selection of suitable plasmapheresis donors according to the effective policies

and procedures as well as the as the clinical experience.

Observe and confirm compliance of the Center's medical procedures as they affect the safety of

the donors and the collected plasma.

Responsible for the certification, training and performance of the center medical staff as it

pertains to the donor assessment and to compliance with the company's policies and procedures.

Provide additional necessary training, re-certification and corrective actions for the center's

medical staff, in collaboration with the training department.

Perform the required physical examination for donors.

Review donor's related documents carefully.

Carefully explain the Informed Consent and witness the donor's signature on the form.

In a private and confidential setting, discuss the high-risk behavior educational material and

definitions of high-risk behavior categories in order to provide the donor with the ability to self exclude

from donating.

Participate in the notification and counselling of donors found to be positive for various

infectious disease markers such as HBV, HIV, HCV, syphilis, and other required tests.

Management of Donor Adverse Event Reactions and the appropriate level of care.

Timely review of accumulated data to confirm established donor suitability, donor safety and

product safety.

Review the accumulated laboratory data of SPE, syphilis and Total Protein results in a timely

basis, as well as the collection records, to determine whether the donor should be deferred for

further donation.

Approve a donor whose SPE results were abnormal for plasmapheresis when normal results are

obtained

Recommend changes and improvements to Standard Operating Procedures.

Provide education sessions to the center medical staff according to the company's Standard

Operating Procedures (SOP).

Learn, understand and be independent working with the PDS (Plasma Donor System).

Follows all GMP and good documentation practice guidelines.

Review the QA reports for timely and appropriate actions on moderate complexity procedures
for test problems.