ISPE to feature eight educational sessions at 2011 Tampa Conference

The International Society for Pharmaceutical Engineering will feature eight educational sessions, including a seminar designed to help pharmaceutical companies identify and address compliance risks prior for FDA inspection, as part of its 2011 Tampa Conference.

01/27/2011


ISPE, a global, not-for-profit association of more than 22,000 professionals, announced that it will feature eight educational sessions, including a seminar designed to help pharmaceutical companies identify and address compliance risks prior to FDA inspection, as part of its 2011 Tampa Conference, which will take place 21-24 February 2011 at the Grand Hyatt Tampa Bay in Tampa, Florida USA.

The FDA inspection enforcement trends seminar, titled, “Pharmaceutical Inspections and Compliance: Current FDA Enforcement Trends,” is a two-day event that will address dual FDA /Industry presentations on the topics of enforcement, supply chain and vendors/CMOs, GMP quality systems, Part 11, management responsibility, current inspections, continuous manufacturing, and process validation. The session will be led by FDA Compliance Officer Francis Godwin and Timothy Tyson, Chairman and CEO of Aptuit, Inc., USA, and will feature Sion Wyn, Director of Conformity, Ltd., UK and FDA Consumer Safety Officers Brian Belz and Grace McNally as speakers.

Other educational sessions will include:

  • Quality Risk Management: Focused, Practical Application – Participants in this session will learn to build and implement a QRM strategy, apply tools and techniques to educate various teams and management levels to the QRM approach, explain how to document QRM to ensure its effectiveness, and adapt QRM applications that have worked for others.
  • Syringe Processing Workshop – The second annual syringe workshop will present new case studies, technology, and innovative ideas in clinical operations, high volume pharmaceuticals and biologicals for existing or new operations. Topics will cover all aspects of prefilled syringes from process and product development, packaging component issues, quality assurance considerations, and inspection hot topics.
  • Containment: A Risk-Based Approach – This session will feature a discussion evaluating containment systems and approaches specifically for potent and highly hazardous compounds. As part of this seminar, the FDA will be invited to speak on how science and risk-based approaches to containment are viewed.
  • Energy Saving Projects – Case Studies and Tools for Saving Energy – This seminar will present four case studies of energy improvement projects that have decreased the amount of utilities consumed resulting in lower production cost and increased energy intensity. Topics addressed will include water, steam, HVAC, electricity, process efficiency, funding, and rebates.

In addition to the educational content being presented, the 2011 Tampa Conference will feature three training courses:

  • Cleaning Validation Principles – This course will cover elements of a cleaning validation program from start to finish, exploring such concepts as the determination of residues to be targeted, selection of analytical and sampling methods, determination of appropriate limits in various pharmaceutical and biotechnology processes, and establishment of scientific rationales acceptable to regulatory inspectors.
  • Containment Fundamentals – This course will focus on airborne contaminants and begin by discussing the definition, history, and rationale for the containment of compounds and processes.
  • Process Validation in Biotechnology Manufacturing – This course is designed to provide a clear understanding of the regulatory, scientific, and engineering tools required to successfully develop and validate bioprocesses. This course also includes a pre-recorded online webinar that will allow participants to review fundamentals of the subject matter prior to the course.

Complete seminar agendas and training course outlines for the 2010 Tampa Conference are available on the ISPE Web site. To register for the conference, visit www.ISPE.org/2011TampaConference, or call ISPE Member Service at telephone +1-813-960-2105. For press passes to attend this event, contact Danielle Hould, ISPE Communications Manager, by telephone at +1-813-960-2105 or via email at dhould(at)ispe.org.

www.ispe.org

The International Society for Pharmaceutical Engineering

- Edited by Amanda McLeman, Plant Engineering, www.plantengineering.com



Top Plant
The Top Plant program honors outstanding manufacturing facilities in North America.
Product of the Year
The Product of the Year program recognizes products newly released in the manufacturing industries.
System Integrator of the Year
Each year, a panel of Control Engineering and Plant Engineering editors and industry expert judges select the System Integrator of the Year Award winners in three categories.
July/Aug
GAMS preview, 2018 Mid-Year Report, EAM and Safety
June 2018
2018 Lubrication Guide, Motor and maintenance management, Control system migration
May 2018
Electrical standards, robots and Lean manufacturing, and how an aluminum packaging plant is helping community growth.
April 2018
2017 Product of the Year winners, retrofitting a press, IMTS and Hannover Messe preview, natural refrigerants, testing steam traps
August 2018
SCADA standardization, capital expenditures, data-driven drilling and execution
June 2018
Machine learning, produced water benefits, programming cavity pumps
April 2018
ROVs, rigs, and the real time; wellsite valve manifolds; AI on a chip; analytics use for pipelines
Spring 2018
Burners for heat-treating furnaces, CHP, dryers, gas humidification, and more
August 2018
Choosing an automation controller, Lean manufacturing
February 2018
Setting internal automation standards

Annual Salary Survey

After two years of economic concerns, manufacturing leaders once again have homed in on the single biggest issue facing their operations:

It's the workers—or more specifically, the lack of workers.

The 2017 Plant Engineering Salary Survey looks at not just what plant managers make, but what they think. As they look across their plants today, plant managers say they don’t have the operational depth to take on the new technologies and new challenges of global manufacturing.

Read more: 2017 Salary Survey

The Maintenance and Reliability Coach's blog
Maintenance and reliability tips and best practices from the maintenance and reliability coaches at Allied Reliability Group.
One Voice for Manufacturing
The One Voice for Manufacturing blog reports on federal public policy issues impacting the manufacturing sector. One Voice is a joint effort by the National Tooling and Machining...
The Maintenance and Reliability Professionals Blog
The Society for Maintenance and Reliability Professionals an organization devoted...
Machine Safety
Join this ongoing discussion of machine guarding topics, including solutions assessments, regulatory compliance, gap analysis...
Research Analyst Blog
IMS Research, recently acquired by IHS Inc., is a leading independent supplier of market research and consultancy to the global electronics industry.
Marshall on Maintenance
Maintenance is not optional in manufacturing. It’s a profit center, driving productivity and uptime while reducing overall repair costs.
Lachance on CMMS
The Lachance on CMMS blog is about current maintenance topics. Blogger Paul Lachance is president and chief technology officer for Smartware Group.
Material Handling
This digital report explains how everything from conveyors and robots to automatic picking systems and digital orders have evolved to keep pace with the speed of change in the supply chain.
Electrical Safety Update
This digital report explains how plant engineers need to take greater care when it comes to electrical safety incidents on the plant floor.
IIoT: Machines, Equipment, & Asset Management
Articles in this digital report highlight technologies that enable Industrial Internet of Things, IIoT-related products and strategies.
Randy Steele
Maintenance Manager; California Oils Corp.
Matthew J. Woo, PE, RCDD, LEED AP BD+C
Associate, Electrical Engineering; Wood Harbinger
Randy Oliver
Control Systems Engineer; Robert Bosch Corp.
Data Centers: Impacts of Climate and Cooling Technology
This course focuses on climate analysis, appropriateness of cooling system selection, and combining cooling systems.
Safety First: Arc Flash 101
This course will help identify and reveal electrical hazards and identify the solutions to implementing and maintaining a safe work environment.
Critical Power: Hospital Electrical Systems
This course explains how maintaining power and communication systems through emergency power-generation systems is critical.
click me