ISPE Training

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Practical Implementation of Process Validation Lifecycle Approach (T46)
11-13 May 2016 | 8.30am - 5.00pm | Concorde Hotel Singapore
Introduction to Statistics for Validation Workshop 
10 May 2016 | 2.00pm - 5.00pm | Concorde Hotel Singapore
ISPE Singapore Affiliate is pleased to invite you to an exclusive  ISPE certified Process Validation Training and a  FREE Introduction to Statistics for Validation Workshop   (valued at S$ 495) when you register. 

SAVE on travel, accommodation and over S$ 2,000 in registration fees by attending this course in ASIA!

Following is a brief write-up and links with detailed information on the course and trainers.
Course Summary
Do you need a practical understanding of process validation (PV) principles and expectations in the US and EU?

This 3-day course will define the  requirements for preparation, planning and execution of Validation/Process Validation  and how to maintain a state of control. It explores the 3 Stages of the validation product lifecycle, including Process Design, Equipment and Utility Qualification, establishing and implementing Process Performance Qualification (U.S.) or Process Validation (Europe) requirements, and putting in place an Ongoing/Continued Process Verification program. The course is applicable to all sectors of the pharmaceutical industry - small and large molecules, innovators and generics. 
The content comprises a blend of presentation of concepts and details, followed by related practice application scenarios/exercises.


Who Should Attend
This course is relevant to individuals involved in process validation of products and processes in all sectors of the pharmaceutical industry - small and large molecules, innovators, generics, and lifecycle management.

Specific job functions include:
Development, manufacturing, engineering, quality, and validation professionals with intermediate level experience in development, manufacturing, engineering, validation, quality, technology transfer and those wishing to understand the concept of process validation as a lifecycle.

Trainers
Bruce Davis, Principal, Global Consulting  
is a professional engineer, and has many years' experience in the pharmaceutical industry and a wide international knowledge, and operates a consultancy in QbD, Engineering, Process Validation and Quality Risk Management.
He is an Associate to NSF Health Sciences, the training & consultancy Company. He previously worked at AstraZeneca, where he had a number of responsibilities, including managing international engineering and facilitating application of Quality by Design.

Maurice Parlane, a Director of Centre for Biopharmaceutical Excellence Pty Ltd, of Australia and Principal/Director of New Wayz Consulting Ltd
is a professional engineer from New Zealand with 29 years' experience in technical and consulting roles within the biopharmaceutical industry, including 19 years as an industry consultant.


Registration
As places for the 3-day course are limited to 40, we recommend that you register yourself / your team early to avoid disappointment.

Price in Singapore Dollars S$
Per delegate
EARLY BIRD
Register & Pay before 11 April
STANDARD
Register & Pay after 11 April
Pre-Event Statistics Primer ONLY 
(10 May)
Member
1,795
1,995
395
Non-member
1,995
2,195
495

Group Discounts
  • 3 - 5 participants - Save 10%
  • 6 - 10 participants - Save 15%
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Contact Us
ISPE Singapore Affiliate
Ph +65 6826 1105
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