Change Control & Risk Assessment in Secondary Packaging

(藥物二次包裝之變更控制及風險評估)
  

Target Audience 

• Members of the Pharmaceutical Distributors Association of Hong Kong (PDA)

• Person-in-charge／Quality Assurance Officer of secondary packaging of licensed manufactures of secondary packaging.

Course Highlight

Module 1 : Change Control

• Introduce type of critical changes in a pharmaceutical quality management system

• Discuss the life cycle of change management

• Develop change control plan

• Introduce post-implementation evaluation after change

• Review the required documentation

​Module 2 : Risk Assessment

• Discuss the possible risks incurred by a change

• Use cause-effect diagram and Failure Mode and Effects Analysis (FMEA) table for risk analysis

• Discuss the approach for risk prioritization

• Review the required documentation

Certificate for Completion 

• Participants who have pass the examination（scores above 70%; Multiple Choice Question）will be awarded the “Certificate for Completion” issued by Hong Kong Quality Assurance Agency.

Continuing Professional Development (CPD) Training Program

• Equivalent to 4 CPD Hours

• Approved Course Code：CPD/L/05/2022

• CPD hours would only be awarded one-off on completion of the course and NO CPD hours would be awarded upon repeated attendance within 24 months. 

Download course leaflet

Should you have any questions, please contact Ms. Joanne Chan during office hour.

Tel: (852) 2202-9330                 Email: training@hkqaa.org

Office Hour: 9 a.m. to 6 p.m. (Monday to Friday), except public holiday