RAPS pre-approved webinar on "Keys to an Effective Technology Transfer as an Element of the Knowledge Management Requirements from ICH Q10"
"Keys to an Effective Technology Transfer as an Element of the Knowledge Management Requirements from ICH Q10" is the topic of a RAPS pre-approved webinar that GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize on March 21.
- Fresno, CA (1888PressRelease) March 21, 2013 - Description:
The Process Validation's 2008 guideline revision specifically mentions Technology Transfer as a step within Stage 2-Process Qualification. Several ingredients need to be met in order to adhere to this requirement. These include 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.
At this webinar, the speaker will elaborately explain the terms associated with technology transfer and describe the requirements for a Technology Transfer Policy and the corresponding documentation. Selection of a Technical Transfer team; the development of a specific plan for each case, and the decision on the criteria for a successful transfer process are the important elements of a sound policy.
Communication is vital to evaluate all aspects that could impact the process or product quality. It is also necessary for ensuring that all the required knowledge has been collected and communicated to all parties involved. This webinar will help participants get an idea of these. It will cover the following areas:
- 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
- Description of the criticality of acceptance of the transfer especially from the receiving unit as a condition that all necessary documentation and knowledge has been effectively communicated.
When: March 21, 10:00 AM PDT | 01:00 PM EDT
By whom:
Miguel Montalvo, who has a B.S. in Chemical Engineering and an MBA, is President, Expert Validation Consulting. He has over 28 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.
He is a well-recognized international speaker on GMP Compliance, Validation and Quality related topics. He is a member of the Journal of Validation Technology editorial board and of the PDA Annual Program Committee for their Annual meetings.
For whom:
This webinar will benefit professionals in
- Development
- Quality
- Manufacturing
- Engineering
- Top Management
Duration: 90 minutes
To enroll for this webinar, contact
webinars ( @ ) globalcompliancepanel dot com
Phone: 800-447-9407
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