Engaged. Knowledge. Application
Live Online Training: FDA's New Process Validation Guidance
Event Details
Time: February 24, 2011 from 10:45am to 12pm
Location: Your Computer
Website or Map: http://enkap.com/page/live-on…
Phone: 561-308-3093
Event Type: live, online, training
Organized By: enKap
Latest Activity: Jan 31, 2011
Event Description
Primer on Actions You Need to Begin Taking NOW
Live Online Training Content:
Background on FDA's New Guidance on Process Validation
- Why did FDA upgrade the Guidance on process validation now?
- Alignment with ICH Q8, Q9, and Q10
- Definition and goal of process validation
- Former approach compared to FDA's new approach
- Stage 1 - Process design
- Stage 2 - Process qualification
- Stage 3 - Continued process verification
- New Keys to a successful validation program
- Understand the sources of variation
- Detect the presence and degree of variation
- Understand the impact of variation on the process and product
- Control the variation commensurate with risk
- General considerations for process validation
- Stage 1 - Process Design: Key points and practical applications for:
- Building and capturing process knowledge and understanding
- Establishing a strategy for process control
- Stage 2 - Process Qualification: Key points and practical applications for:
- Design of a facility and qualification of utilities and equipment
- Process performance qualification (PPQ)
- PPQ protocol
- PPQ protocol execution and report
- Stage 3 - Continued Process Verification: Key points and practical applications for:
- Concurrent Release of PPQ Batches
- Documentation
- Analytical Methodology
- What is FDA trying to accomplish and what benefits can be expected from this approach to process validation?
- What specific actions do we need to take now?
- Summary, conclusions, and final recommendations
REGISTER TODAY in the enKap store - click here
Comment Wall
Contact enKap
Phone: +1-561-308-3093
125 South State Road 7, Suite 104-222, Wellington, Fl, 33414, U.S.A.
enKap Terms and Conditions
enKap Terms and Conditions
All sales are final
Legal Disclaimer
This product and any of its enclosures, attachments or appendices, references to online information, conferences or preparations of materials in a variety of formats are created to provide you with accurate and authorative information concerning the subject matter covered. However, this product and any other ancillary items disseminated in connec-
tion with same are not necessarily prepared by a person licensed to practice law in a particular jurisdiction.
enKap, Inc. is not engaged in rendering legal advice, and this product is not a substitute for the advice of an attorney. If you require legal or other expert advice, you should seek
the services of a competent attorney or other professional.
enKap, Inc. necessarily is not, cannot and will not be liable for any claims, damages, or regulatory legal proceedings initiated as a consequence of you, the customer, modifying,
altering, adding to or deleting portions of any product initially provided by enKap, Inc.
Once any original document provided by enKap, Inc. to you, whether in print or electronic format, has been manipulated or customized by you, then the responsibility for the
document’s accuracy, correctness, and compliance are solely yours.
If any action, claim for damages, or regulatory proceedings is commenced against enKap, Inc. as a consequence of your alteration or modification, etc. of the document templates
or other originally provided materials, then and in that event, you agree to indemnify enKap, Inc. for such claims, and for any attorney’s fees expended by enKap, Inc. in connec-
tion with defense of same.
© copyright 2010 enKap
© 2012 Created by enKap.
