Category Archives: Programs

Applying ASTM E2500

On October 23rd, ISPE LA held a program about Applying ASTM E2500.

Phil Bowles, Director of Engineering at Amgen Inc., talked about the journey towards a fully mature risk-based approach for commissioning and qualification of equipment and facilities.

Mr. Bowles spoke about the industry’s risk-based approach based on the ASTM E2500 Guide. He explained that ASTM E2500 is a Standard Guide for Specification, Design and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment. It provides a science (ICH Q8) and risk (ICH Q9) based approach to assure that GMP equipment & systems are fit for use, perform satisfactorily, and may be used in the manufacturing, processing, packaging, and storage of a drug. It applies the concept of critical quality attributes and calls for the use of subject matter experts (SMEs) to make critical determinations, and redefines roles for Quality and Technical SMEs. It allows flexibility so that the company determines the methodology.

Continue reading

Tagged , , ,

Particle Monitoring for Aseptic Pharmaceutical Manufacturing Guidance

Particle Monitoring 

for Aseptic Pharmaceutical Manufacturing Guidance

Wednesday, January 21, 2015

3:30-6:30 pm

Continue reading

Tagged , , ,

Evening with Industry Executives

 Evening with Industry Executives

Current State and Challenges of the Pharmaceutical Industry and

ISPE LA’s 20 Year Anniversary Party

Thursday, November 20, 2014

4:00-8:00 pm

Continue reading

Tagged , ,

Learn about Applying ASTM E2500: Improving Robustness and Streamlining Project Delivery Through Science and Risk-Based Commissioning and Qualification

October 23rd, 2014

Program Managers:

Paul Crissman, Biotechnical Solutions

Dona Tseng, Sr. Principal Engineer, Baxter Healthcare

Location:

Baxter Healthcare, 4501 Colorado Blvd., Building 6

Los Angeles, CA 90039

Continue reading

Tagged , , ,

Considerations of Temperature Mapping and Datalogging for GMP-Regulated Products

On August 20th 2014, the ISPE LA/OC APICS joint meeting was held, covering Considerations of Temperature Mapping and Datalogging for GMP-Regulated Products.

Jason Daoust of Masy Systems discussed validation dataloggers, including their trends, considerations, and options in use today.

He presented an overview of how environmental mapping equipment has evolved and how the industry acceptance of validation dataloggers has increased significantly in recent years. Even though no perfect validation datalogger exists today, most major and minor companies are realizing their benefits. There is a wide variety of loggers for specific applications such as temperature ranges and probe types, and each system has trade-offs. Standalone validation dataloggers vary in temperature ranges (anywhere from -200C to 400C+), humidity ranges (typically anywhere from 0% to 95%), pressure (typically 0 to 72.5 psia) and time.

Continue reading

Tagged , , , , ,

ISPE LA Half Day Aseptic Processing for Today and Tomorrow

ISPE LA Half Day Aseptic Processing for Today and Tomorrow

September 9, 2014

Noon-6:30 pm

Continue reading

Tagged , , ,

ISPE LA / OC APICS Joint Meeting

ISPE LA

ISPELAlogo

 OC APICS

Screen Shot 2014-07-05 at 4.26.40 AM

Joint Meeting

Considerations of Temperature Mapping and Datalogging for GMP-Regulated Products

August 20 2014

Continue reading

Tagged , , , ,
%d bloggers like this: