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GlobalCompliancePanel, Online Training, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA
2013-12-10
Overview: The webinar 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 communication 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.
Why should you attend: The revised Process Validation guideline from 2008 specifically mentions Technology Transfer as a step within Stage 2 - Process Qualification. This requirement demands a concrete policy, agreement between the sender and receiver units, a plan, documentation and conclusions including a signed report that both parties agree that the transfer was conducted and is deemed effective and complete.
Course Modules & Content Details: Regulatory Background - Revised PV Guideline and ICH Q10
Elements of a Technology Transfer Policy - who, what, when, How?
Documentation requirements - Plan, evidence of evaluations/testing, signed report
Specific areas to consider for different types of processes
Areas Covered in the Session: Development of a Tech Transfer Policy including how to define specific plans for each transfer and the collection of the corresponding documentation.
List of areas to be considered for evaluation during the revision of the process to be transferred.
Describe the criticality of acceptance of the transfer specially from the receiving unit as agreeing that all necessary documentation and knowledge has been effectively communicated.
Who Will Benefit: Development
Quality
Manufacturing
Engineering
Top Management
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Organized by:
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GlobalCompliancePanel |
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Invited Speakers:
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Miguel Montalvo, B.S. Chem. Eng., MBA, President, Expert Validation Consulting, has over twenty-eight 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.
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Deadline for Abstracts:
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2013-12-10
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Registration:
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Contact Information: NetZealous LLC, DBA GlobalCompliancePanel 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA USA Phone:800-447-9407 Fax: 302-288-6884 webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com
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E-mail:
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support@globalcompliancepanel.com
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