This seminar is hosted by MHLW and PMDA

Summary:

The Seminar will focus on “Quality Assurance of Sterile Medicinal Products -Annex1-” and will consist of interactive discussions, presentations, and workshops. It is an ideal opportunity for both novice and experienced inspectors to enhance their inspection skills through knowledge sharing and discussion. This seminar is intended to provide a further understanding of Annex1 based on issues discussed during its ongoing revision and through a case study of sterility assurance. The seminar will also allow participants to acquire skills on how to make risk-based decisions during GMP inspections.

The workshops will focus on the quality assurance of sterile medicinal products. As the first attempt of the PIC/S workshop, we will provide videos recorded at manufacturing sites as case study materials. The videos of the practical manufacturing operations are expected to enhance active discussion in the workshops.


After the seminar, participants are welcome to join an optional half-day excursion for your charge. You can visit the World Heritage “Gokayama Historic Village” in Toyama if you would like.

“Quality Assurance of Sterile Medicinal Products - PIC/S GMP Guide Annex1-”
Venue: ANA Crowne Plaza Toyama

11 November, 2019 Monday
Day 1: 8:30 AM - 18:00 PM

8:30 AM - 12:30 PM Executive Bureau Meeting
(Coffee Break 10:00 AM – 10:30 AM)
12:30 PM - 14:00 PM Lunch
14:00 PM - 18:00 PM Committee Meeting
(Coffee Break 15:30 PM – 16:00 PM)

12 November, 2019 Tuesday
Day 2: 9:00 AM - 17:00 PM

9:00 AM - 12:30 PM Committee Meeting
(Coffee Break 10:30 AM – 11:00 AM)
12:30 PM - 14:00 PM Lunch
14:00 PM - 17:00 PM Committee Meeting
(Coffee Break 15:00 PM – 15:30 PM)
14:30 PM - 17:00 PM Seminar Registration Table
18:00 PM - 20:00 PM Seminar Welcome Reception

13 November, 2019 Wednesday
Day 3: 9:00 AM - 17:10 PM

8:00 AM - 17:00 PM Seminar Registration Table
9:00 AM - 9:15 AM Welcome and Opening Remarks from Japan,
Opening Remarks from PIC/S Chairman
9:15 AM - 10:00 AM Presentation – Summary of Revising Annex 1
10:00 AM - 10:45 AM Presentation – Discussed Points During Revision
10:45 AM - 11:10 AM Coffee Break
11:10 AM - 11:55 AM Presentation – Process Simulation Test (PST)
11:55 AM - 12:40 PM Presentation – Clean Room Management for Sterile Products
12:40 PM - 13:40 PM Lunch
13:40 PM - 15:10 PM Workshop
W1: Process Simulation Test (PST)
W2: Clean room qualification and Environmental Monitoring
15:15 PM - 15:30 PM Photo Session
15:30 PM - 16:00 PM Coffee Break
16:00 PM - 17:30 PM Workshop
W1: Process Simulation Test (PST)
W2: Clean room qualification and Environmental Monitoring
18:30 PM Networking Event

14 November, 2019 Thursday
Day 4: 9:00 AM to 17:00 PM

8:00 AM - 17:00 PM Seminar Registration Table
9:00 AM - 10:00 AM Presentation – Risk-management for sterile products
10:00 AM - 11:00 AM Presentation – Single use (SU) System
11:00 AM - 11:30 AM Coffee Break
11:30 AM - 12:30 PM Presentation – Management of WFI
12:30 PM - 13:30 PM Lunch
13:30 PM - 15:00 PM Workshop
W3: Single Use
Workshop
W4: Restricted Access Barriers technology (RABS) and Isolators
15:00 PM - 15:30 PM Coffee Break
15:30 PM - 17:00 PM Workshop
W3: Single Use
Workshop
W4: Restricted Access Barriers technology (RABS) and Isolators

15 November, 2019 Friday
Day 5: 9:00 AM to 13:40 PM

8:00 AM - 13:30 PM Seminar Registration Table
9:00 AM - 10:00 AM Presentation – Examples of observations for Sterile Products
10:00 AM - 11:00 AM Presentation – Rapid Microbiological Methods
11:00 AM - 11:30 AM Coffee Break
11:30 AM - 12:10 PM Summary of Workshop by Facilitators and Panel discussion
12:10 PM - 12:25 PM 2020 Seminar Address
12:25 PM - 12:35 PM Closing Remarks from Japan, Host Country and the Presentation of the PIC/S Walking Stick - Presented to Thai FDA
12:35 PM - 12:40 PM Closing Remarks from PIC/S Chairman
12:40 PM - 13:40 PM Lunch
NOTE:This is a closed event for Regulators only. Non-regulators will not be considered and should not register.
25 April, 2019