2018 PIC/S Annual Seminar

Summary:
This Seminar will explore the best practices impacting risk assessments and look to share tools and techniques generated from experienced inspectors to aid in conducting insightful and critical evaluations.
 We will identify differences in risk management approaches in an effort to harmonize how we assess and manage risk.

The number of risk evaluations we conduct as pharmaceutical inspectorates is seemingly endless. We incorporate risk in our site selection models to determine sites to inspect and assess which critical products and processes to cover on inspection. This includes a critical evaluation of the quality of the data generated, submitted, and maintained by the firm.
Assessment of risk is also critical when reviewing information to avert and manage drug shortages, ensuring inspector safety, and scrutinizing a firm’s quality management system. Ultimately, firm’s risk management decisions determine whether it is able to safeguard the drug supply chain throughout its lifecycle.

This two-and-a-half-day Seminar of presentations and workshops will provide participants with information to consider in 
assessing risk from raw material receipt through supply chain distribution.  

Management of Risk through the Product Life-Cycle 


Pre-Seminar Program (Day 1: Monday, 24 September 2018)


Time


Topic

08:45 AM

Coffee Service

9:00 AM

PIC/S Executive Bureau Meeting

12:30 PM

PIC/S Executive Bureau Lunch

2:00 PM

PIC/S Committee Meeting

3:30 PM

Break

4:00 PM

PIC/S Committee Meeting (continued)

Pre-Seminar Program (Day 2: Tuesday, 25 September 2018)


Time


Topic

09:00 AM

PIC/S Committee Meeting (continued)

10:30 AM

Break

11:00 AM

PIC/S Committee Meeting (continued)

12:30 PM

PIC/S Committee Lunch

1:45 PM

PIC/S Committee Meeting (continued)

3:00 PM

Break

3:30 PM

PIC/S Committee Meeting (continued)

6:00 PM

PIC/S Seminar Welcome Reception and Registration

Seminar Program (Day 3: Wednesday, 26 September 2018)
Process and Production Plant Risks

Time

Topic

09:00 AM

Welcome to Seminar and Opening addresses

9:30 AM

Perspectives on risk throughout the product life-cyle 
(Panel discussion)

10:30 AM

Break

11:00 AM

Quality oversight through the upstream supply chain – 
Part 1: Purchased raw materials

11:30 AM

Quality oversight through the upstream supply chain – 
Part 2: Contracted services

12:00 PM

Maintaining Process Control

12:30 PM

Lunch

1:50 PM

Workshop # 1 – Risk related to raw materials and contract services

Workshop #2 - Emerging technologies

3:10 PM

Break

3:40 PM

Workshop # 1 – Risk related to raw materials and contract services

Workshop #2 - Emerging technologies

5:00 PM

Close

Seminar Program (Day 4: Thursday, 27 September 2018)
Risk to the Product

Time

Topic

09:00 AM

Scene setter for day

9:15 AM

Quality oversight through the downstream supply chain: Finished products

10: 30 AM

Break

11:00 AM

Risk based inspections

12:00 PM

Lunch

1:20 PM

Workshop 1 – Risk in the distribution chain

Workshop 2 – Risk-based inspections

2:40 PM

Break

3:10 PM

Workshop 1 – Risk in the distribution chain

Workshop 2 – Risk-based inspections

4:30 PM

Close

6:00 PM

Depart for Seminar Dinner

Seminar Program (Day 5: Friday, 28 September 2018)
Risk to Patients and Personnel


Time


Topic

09:00 AM

Start of day (US FDA intro)

9:05 AM

Drug shortage risk

09:35 AM

Workshop summary session

10:05 AM

Break

10:35 AM

Inspector safety

11:45 AM

Perspectives on risk – recap and closing perspectives

12:00 PM

2019 Seminar address – Japan

12:15 PM

Closing address & presentation of the PIC/S walking stick

12:30 PM

Departures

 
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