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Keys to an Effective Technology Transfer as an Element of the Knowledge Management Requirements from ICH Q10
Overview
The seminar will define the terms associated with technology transfer and describe the requirements for a Technology Transfer Policy and the corresponding documentation. The policy will include the selection of a Tech. Transfer team, the development of a specific plan for each case and the decision on the criteria for a successful transfer process. The key is comjunication and to evaluate all aspects that could impact the process or product quality to make sure all the required knowledge has been collected and communicated to all parties involved.
Who Should Attend
Development, Quality, Manufacturing, Engineering and Top Management
Industry: Pharmaceutical,Biotechnology, Medical Device
Learning Objectives
Attendees will learn how to:
• Be able to develop a Tech Transfer Policy, define specific plans for each transfer and the collection of the corresponding documentation.
• Understand the areas to be considered for evaluation during the revision of the process to be transferred.
• Understand the criticality of acceptance of the transfer specially from the receiving unit as agreeing that all necessary documentation and knowledge has been effectively communicated.
This webinar will identify the following challenges/issues and discuss solutions being offered
Challenge is to provide the tools for an effective transfer of all knowledge gathered at the time of the transfer so issues can be minimized after this event.
Presenter
Miguel Montalvo
Expert Validation Consulting, Inc.
Miguel Montalvo, B.S. Chem. Eng., MBA, has over twenty-seven years of professional/management experience in positions of increasing responsibility in the areas of Quality, Validations and Technical Services within the traditional pharmaceutical, OTC Drugs, cosmetics, dietary supplements, biotechnology and medical device industries including extensive expertise on development and implementation of quality functional procedures (QA/QC), Quality Systems, GMP/QSR compliance audits (internal, supplier, external audits), remediation projects with companies on consent decrees, handling of non-conformances (OOS, investigations and deviations), Process/Cleaning/Computer Systems/Equipment/Facility validations, Change Control, CAPA, international GMP compliance, Calibrations, Risk Management, operational compliance assessments/Gap Analysis and start-up of manufacturing facilities.
Before starting EVC, Mr. Montalvo held senior level positions of increasing responsibility in the areas of Validation, Technical Services and Quality Operations in companies such as AAC Consulting Group, Inc, Millipore Corporation, Raytheon Engineers and Constructors, Mova Pharmaceutical Corp., Bristol-Myers Squibb and Baxter Healthcare Corporation. His experience includes roles in the manufacturing side but also from the supplier point of view as QA Manager for the Custom Systems Division of Millipore Corp.
He is a well-recognized international speaker on GMP Compliance, Validation and Quality related topics for organizations such as IVT, PDA-TRI, CfPIE and Barnett International and his articles/papers have been published in the American Pharmaceutical Review and the Journal of Validation Technology publications and have been published as an author of specific chapters in several design/quality/validation related internationally-recognized reference books. He is a previous member of the Journal of Validation Technology editorial board and a current member for the last five years of the PDA Annual Program Committee for their Annual meetings.
Registration Fee
Individual: $225
Group:
2 people: $180.00 each
3 people: $150.00 each
4 people: $120.00 each
5-10 people: $100.00 each
11-15 people: $70.00 each
16-20 people: $60.00 each
21+ people: Call for pricing
Register by December 31and receive 30% discount off above prices.
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