Managing the vendor selection process to reduce implementation time and cost
[due to change of date of the event - training timing is still to be confirmed]
Gran Hotel Dino, Baveno, Lake Maggiore, Italy
Mark Newton comes over to Europe and offers a unique opportunity to get introduced to best practices
Mark E Newton, Principal at Heartland QA
Mark Newton is an independent consultant who specializes in data integrity, laboratory informatics, computer systems validation, and Quality. He has 35 years of experience in the pharmaceutical industry in QC Labs, computer systems validation and lab informatics at Eli Lilly
Mark co-lead Eli Lilly’s data integrity remediation program for QC Labs worldwide in 2012, consulted and audited several Lilly sites preparing for data-integrity focused inspections.
Mark is a co-leader for the GAMP Data Integrity Special Interest Group and Chair of ISPE Global Documents Committee.
Co-author of "Harmonizing USP <1058> and GAMP for Analytical Instrument Qualification" Schuessler, Newton, Smith, Burgess, McDowall. Pharm. Engineering, Jan/Feb 2014
Co-editor of the GAMP Good Practice Guide "A Risk-Based Approach to Compliant Computerized Laboratory Systems" Nov. 2012.
* Note that registration to the training doesn´t include access to the Congress.
At the conclusion of the workshop, attendees will know better about the critical issues to examine prior to purchase, how to use vendor information, both about quality of the vendor’s process and the software’s design. Participants will also know where they should perform testing, based on criticality of requirements, where to use vendor’s testing, and what controls will need to be developed during validation to deploy the system in a regulated environment.
Time will be provided for Q&A on the topics covered in the workshop.
Practical examples of Risk Management will be used throughout the workshop to demonstrate areas of focus, high risk and areas of low risk.
During the workshop will discuss the common factors in lab environments that drive risks up and down when working in automation projects.
Understand vendor’s quality process and software design to maximize use of vendor’s quality activities and reduce cost and time to validate systems for internal use in a regulated environment.
WHO SHOULD ATTEND
This workshop will benefit people who expect to select any lab automation or software product in the coming year, anyone involved in validating equipment or software (IT, Quality or scientific roles), or vendors who want to create happy customers by providing them with information to successfully implement their product.