Event:
Session:
WASHINGTON 2010 CONFERENCE
Leaders:
Dates:
Location:
E06: FDA-ISPE Collaboration: Pharmaceutical Quality
Systems
Grace McNally, Joe Famulare
Wednesday-Thursday 9-10 June 2010
Washington, D.C.
Wednesday, 9 June
Start End
Time Time
7:30
9:00
9:30
Presentation Title
Speaker
(Leader and Speaker Breakfast 7:00)
Breakfast
Welcome and Introductions - Outlining the Challenges
Joseph Famulare
Industry is Experiencing in Implementing Q10
10:30 Keynote: Executive Leadership and and Effective Quality Deborah Autor,
invited
System
A pharmaceutical quality system is only as effective as the
corporate and management commitment behind it. This
Keynote will share FDA’s view on management responsibility
to be informed, and to provide leadership and efficient
pathways for innovation. It will also discuss management
support of continual improvement to serve the public health
with safe, efficacious, high quality drugs as well as the
company’s performance and reputation.
9:00
9:30
10:30
11:00
11:00 Networking Break
11:30 Process Performance and Product - Regulatory Perspective Grace McNally
11:30
Deborah Baly
12:00 Process Monitoring & Product Quality Management Industry Perspective
This presentation will include an overview of ICH Q10
(Section 3.2.1) as it relates to process performance, product
quality monitoring systems and how the new FDA Process
Validation guidance ties with ICH Q10
Q10. It will also cover: (1)
approaches currently being used at Genentech to assess
process/product consistency over the product lifecycle and
across a complex manufacturing network; (2) statistical
approaches for process monitoring/data trending with
relevant examples: (3) concept of variation and benefits of
process/product data trending along with how to identify
trends in product/process data; (4) potential expectations
from the industry on ICH Q10; (5) the integration of QbD into
statistical monitoring programs; (6) and implementation of
product quality management oversight highlighting
Genentech's Product Steward model.
12:00
13:00
13:00 Lunch
13:30 Process Performance and Product - Industry Perspective
Rob Hughes
Small Molecule
Process Performance: Cradle to Grave
This presentation will cover the concept of a product steward
and how this approach is applied to small molecules during
development and commercial manufacture.
13:30
14:15 Town Hall on Process Performance and Product
- Questions
- Feedback in true "Town Hall" Fashion
14:45 Networking Break
14:15
Joseph Famulare
Grace McNally
Company
Genentech
FDA Office of
Compliance
FDA
Genentech
AstraZeneca
Genentech
FDA
14:45
15:15
15:45
16:30
17:00
15:15 Corrective and Preventive Action - Regulatory Perspective
- examples from 483's
15:45 Corrective and Preventive Action - Industry Perspective
(Root Cause Analysis: What is the Apparent vs. the True
Cause for CAPA)
16:30 Implementing CAPA Across Sites - The Globalization
Challenge
17:00 Town Hall on CAPA
- Questions
- Feedback in true "Town Hall" fashion
Seminar Adjourns, Reception
Kristy Zielny
FDA
Russell Somma
SommaTech
Bryan Liptzin
Amgen
Joseph Famulare
Grace McNally
Genentech
FDA
Thursday, 10 June
Start End
Time Time
7:00
8:00
8:00
8:15
Presentation Title
Breakfast
Welcome to Day Two
Speaker
Joseph Famulare
Grace McNally
Monica Caphart,
invited
Rose Mary Dollard
8:15
8:45
Change Management - Regulatory Perspective
8:45
9:15
Managing Change During Technology Transfer
Change management is one of the key elements within a
Pharmaceutical Quality System that assures a state of
control is maintained. It spans from product development
through product discontinuation. This session will focus on
the application of change management during the technology
transfer life cycle phase and includes a practical change
management example for use during equipment and facility
start up activities.
9:15
10:00 Town Hall - Discussion from the Quality System Perspective Joseph Famulare
Grace McNally
10:30
10 30 Networking
N t
ki Break
B k
11:00 Technology Transfer: Case Study
Larry Kranking
- Cultural perspectives
- Implementing QbD in Tech Transfer
10:00
10
00
10:30
11:00
11:30 Tech Transfer: The QbD Pilot
- QbD Pilot for OBP
- Use of QRM for Site Transfer
- Smooth regulatory fit from site to site, fitting process to the
facility
Krista Terry
11:30
12:00 Knowledge Management (KM): Some Ways Industry
Marty Lipa
Addresses This
- A focus on what KM means in the context of ICH Guidance
(Q8, Q9, Q10)
- Describe what KM means and key KM tenets
- Profile KM multi-phase model: capability build and
challenges
Genentech
FDA
FDA
Johnson &
Johnson
Genentech
FDA
Aveta
Lifesciences
Genentech
Merck
12:00
13:00
13:30
14:00
14:30
15:00
16:00
13:00 Lunch
13:30 Outsourcing Outside the Organization: A Complicated
Challenge - Regulatory Perspective
14:00 Outsourcing Outside the Organization: A Complicated
Challenge - Industry Perspective
14:30 Management Review: The Steps and the Challenges -Governance Systems that Work for Reporting to Senior
Management
- Articulate the value of a strong management review
process
- Understand the challenges of management review in a
large company
- Identify key elements of management review processes
that work
15:00 Networking Break
16:00 Questions and Answers
Seminar Adjourns
**Please Note that Agendas are Subject to Change
Rosa Motta
FDA
Natalie Garrett
Abbott
Mary Oates
Pfizer
All Speakers
Joseph Famulare
Grace McNally
Genentech
FDA