ISPE will present several important sessions this year at its Washington conference, 4-7 June 2007 at the Crystal Gateway Marriott in Alexandria, Virginia, USA
On 6-7 June 2007, the US Food and Drug Administration (FDA) and ISPE will co-sponsor practical sessions on Product Quality Lifecycle Implementation (PQLI), and interactive workshops that will turn theory into reality.
These sessions will allow industry professionals to help guide the future of the industry.
ISPE Facility Summit 2007: Innovative Ideas for Accelerating Performance held 4-5 June will be an intensive briefing and forum to interact and inspire leading industry professionals, and will feature the Facility of the Year Awards (Foya) 2007 category winners, who will provide insight and real life case studies into the world of facilities.
Other important sessions during the four-day conference include:.
16th annual barrier isolation technology forum.
Critical utilities: the latest on water, steam, and gas systems - regulatory updates, commissioning and qualification, design and operational issues.
Newly released API (bulk) baseline guide, review by developers and application implications.
Containment technology forum: risk Mapp and applying ICH Q9 principles.
Gamp validation of automation and computerized systems related to manufacturing systems, and round table discussions.
FDA co-sponsored sessions on product quality lifecycle implementation (PQLI).
Participate in two days of foundational, interactive sessions 4-5 June with the FDA and industry leaders on Product Quality Lifecycle Implementation (PQLI) that will help create a pragmatic approach to harmonising Q8 and Q9.
These are the first in a series of meetings that will ultimately result in guidances produced by ISPE for the industry.
Leaders from science, manufacturing quality and engineering will be able to engage with the FDA and other regulatory agencies.
"The PQLI session is at the forefront of the industry, providing the framework for a pragmatic approach to how to really implement Q8 and Q9, while helping shape the future thinking of the industry," said Bruce Davis, a session leader, and global capital director at AstraZeneca.
The goal of these sessions is to begin to define areas where industry will be able to provide the technical framework for the implementation of quality by design (QbD) in regulatory submissions.
This ground-breaking event will comprise six break-out sessions for working groups to comment on and capture industry input, including API design space, DP design space, API critical versus non-critical, DP critical versus non-critical, API control strategy versus quality by design, and DP control strategy traditional versus QbD.
ISPE facility summit 2007: innovative ideas for accelerating performance.
As the international expert on pharmaceutical facilities, ISPE will offer presentations and innovative case studies from leaders in the field at the ISPE Facility Summit 2007: Innovative Ideas for Accelerating Performance.
This multi-day, multi-track programme will be a unique 'town hall' gathering of top thinkers and service practitioners delivering content in three key areas of project delivery, regulatory, and manufacturing technology/operations, using breakouts, panel discussions and armchair case study presentations, as well as lectures.
These breakouts will target both advanced and beginning levels, focusing on challenges, what the hottest trends are now, and what is ahead for the future.
The two-day programme is designed around 30-minute, intense, content-rich sessions including Facility of the Year awards 2007 category winners with virtual facility tours.
Participants can learn how they solved everyday problems, and can participate in interactive discussions on practical solutions to facility design (new or renovated), construction, building green, and qualification for operational excellence.
16th annual barrier isolation technology forum.
ISPE will host the 16th annual barrier isolation technology forum - innovation updates and new case studies - the longest running barrier isolation technology forum in the world.
ISPE's barrier isolation technology forum, which will be held 4-5 June, is the standard by which all others are measured, and continuously build upon the foundation of knowledge and best practices set in place during previous years, providing a vital opportunity to gain updates and examine new case studies.
Containment technology forum: Riskmapp and applying ICH Q9 principles.
Regulators in the USA and Europe are currently working on regulations that would dictate dedicated facilities for certain classes of compounds.
Help make history - participate in this interactive session that will show industry and regulators how science-based risk assessments can be used to determine when multi-product facilities can safely be employed.
Concepts from the ISPE Risk-mapp baseline guide in development will address how to set safe limits for cross contamination and apply the appropriate containment technology to control within these limits.
Plus, industry experts in toxicology, cleaning, quality, engineering, IH and containment will present a multi-disciplinary approach to applying ICH Q9 to determine risk controls, with a half-day dedicated to cleaning and cleaning validation.
Newly-released technical documents.
The conference will offer seminars examining three newly-released ISPE good practice guides.
Delegates will discuss techniques and solutions from the teams that developed ISPE's just released pharmaceutical industry-impacting technical guides.
These include:.
Commissioning and qualification of water and steam systems good practice guide, 4-5 June.
Newly released API (bulk) baseline guide, review by developers and application implications, 4-5 June.
Gamp validation of automation and computerized systems related to manufacturing systems, and round table discussions, 5 June.
ISPE, the International Society for Pharmaceutical Engineering, is the Society of choice for more than 23,000 pharmaceutical manufacturing professionals in 81 countries around the globe.
ISPE aims to be the catalyst for engineering pharmaceutical innovation by providing members with opportunities to develop technical knowledge, exchange practical experience, and collaborate with global regulatory agencies and industry leaders.
Founded in 1980, ISPE has worldwide headquarters in Tampa, Florida; its European office in Brussels, Belgium; and its Asia Pacific office in Singapore.
