Basic Concepts in Cleaning and Cleaning Validation for GMP Regulated Industries

Thursday, July 12, 2012

Basic Concepts in Cleaning and Cleaning Validation
for GMP Regulated Industries

Why Attend this Seminar?
STERIS Corporation (www.STERISLifeSciences.com) is the industry leader in providing cleaning, cleaning validation and microbial control solutions to the pharmaceutical manufacturing industry. For over 20 years our team of experts has provided non-commercial seminars and presentations based on both current Good Manufacturing Practices and on real-world experience in addressing the cleaning, cleaning validation and microbial control challenges of regulated industries. This seminar will provide industry examples and real-world insights into development of robust cleaning programs, and will provide both a review of relevant regulatory guidance as well as practical information on validation of robust cleaning programs. The focus of this seminar will be processing equipment cleaning and cleaning validation.

Seminar to be delivered in English.

Who Should Attend?
This seminar is designed for professionals in pharmaceutical manufacturing who are responsible for high-quality, efficient, cost-effective, and compliant production results:
Quality Assurance
Regulatory
Plant Manager
Quality Control
Operations
Compliance Officer
Microbiology
Engineering
R and D

Monday, July 16th 2012
BEIJING
To Register Contact: Ms Allen Liu (allenliu@bj.austar.com.cn)
Location: Howard Johnson Paragon Hotel Beijing
No.18 Jianguomen Nei Ave
Dong Cheng District, Beijing
Phone: (86) 10 65266680

Wednesday, July 18th 2012
GUANGZHOU
To Register Contact: Mr Cream Luo (creamluo@sh.austar.com.cn) 
Location: VILI International Hotel
No. 167 Linhe Xi Road
Tianhe District, Guangzhou
Phone: (86) 20 38119999

Friday, July 20th 2012
SHANGHAI
To Register Contact:Ms Grace Li (graceli@sh.austar.com.cn)
Ms Iris Li (irisli@sh.austar.com.cn) 
Location: Holiday Inn Shanghai Vista
700 Changshou Road
Putuo District, Shanghai
Phone: (86) 21 62768888

Monday, July 23rd 2012
SINGAPORE
To Register Contact:
Ms Liza Solano (liza@scimed.com.sg)
Ms Andrea Ho (andrea@scimed.com.sg)
Phone : (65) 67793388
Location: Jurong Country Club
9 Science Centre Road
Singapore 609078
Phone: (65) 65605655

Wednesday, July 25th 2012
AHMEDABAD
To Register Contact: Mr Murali (murali@sterimedgroup.net)
Mr Chandrasekhar (sekhar@sterimedgroup.net)
Phone : +91-466-2259579/2259580/2209316
Location:Grand Bhagavathi Hotel
NH 8C, Bodakdev, S.G. Road
SG Highway, Ahmedabad
Phone : (91)-079-26841000

Friday, July 27th 2012
BADDI
To Register Contact: Mr Murali (murali@sterimedgroup.net)
Mr Chandrasekhar (sekhar@sterimedgroup.net)
Phone : +91-466-2259579/2259580/2209316 
Location:  Legend Sarovar Portico Hotel
Village Malpur, Tehsil Baddi
District Solan, Himachal Pradesh
Phone : (91)-017-95661800

Presenters:
George Verghese is director of technical services in the Life Sciences Division of STERIS Corporation. He directs the technical services group for formulated chemistries and oversees the Process and Cleaner Evaluation (PACE) Laboratory. Mr. Verghese has worked in the areas of manufacturing, product and applications development, and technical services for more than 25 years. Prior to STERIS, he held engineering positions at Bristol-Myers Squibb and Calgon Vestal, a subsidiary of Merck & Co. Mr. Verghese has written numerous articles and book chapters on topics related to contamination control. He is a member of the editorial advisory board of the Journal of Validation Technology and the Journal of GxP Compliance. As a speaker at industry conferences, he has lectured to pharmaceutical industry audiences worldwide on various aspects of process equipment design and cleaning validation. He holds a master’s degree in chemical engineering and is an active member of the ISPE, PDA, and ASTM.

Destin LeBlanc consults in the area of cleaning validation as the owner and principal consultant of Cleaning Validation Technologies. Previously, he had been with STERIS/Calgon Vestal for over twenty years, primarily in product development and technical service for cleaning and antimicrobial applications. He has lectured on issues related to contamination control internationally, and has written widely on cleaning validation issues. He is the author of three books: Validated Cleaning Technologies for Pharmaceutical Manufacturing; Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing- Volume 1; and Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing- Volume 2. He maintains the web site www.cleaningvalidation.com as a resource for cleaning validation professionals. He is a member of PDA and ISPE, is on the faculty of the PDA Training and Research Institute, and regularly trains FDA personnel on cleaning validation. He is a graduate of the University of Michigan and the University of Iowa.


 

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