Process Validation - Current Industry Practices and FDA Guidance Document Review

Duration: 60 Minutes
Process Validation is required by FDA and most worldwide regulatory bodies. Process Validation demonstrates consistency of pharmaceutical production processes. Process Validation requires writing and executing a validation protocol that explores either natural variation or introduced variation in a process and shows that the process can consistently produce a quality product.
Process Validation
Instructor: John R. Godshalk
Product ID: 505327
Writing and executing good process validation can be a daunting task given the complexities of today's biotech and pharmaceutical processes. Guidance's are helpful in writing process validation protocols and deciding what can be, or should be, varied in the process. The notions of critical process control parameters and control limits are introduced and explored as tools for performing process validation.

Objectives of the Presentation
  • Recent guidance documents
  • Industry practices
  • Examples of process validation protocols
  • What should be included in process validation protocols
  • The Importance of good process validation
  • Common mistakes in process validation
Why Should you Attend
Process validation is an important subject for the pharmaceutical quality or regulatory professional. Process validation can be difficult and can cause confusion due to different standards, approaches, and process complexities. In this webinar, the basics of process validation will be explored along with current industry practices. The recent draft FDA Guidance Document on process validation will be reviewed and case studies will be presented that will allow the attendee to see practical examples of process validation protocols.

Who will Benefit
  • Director of Quality
  • Manager of Quality
  • Validation Manager
  • Validation Engineer
  • Validation Director
  • Director/Manager of Regulatory
  • Quality Engineers
  • Production Managers
  • Production Supervisors
  • Manufacturing Engineers
  • Production Engineers
  • Design Engineers
  • Process Owners
$375
Recorded Session for one participant
Get life time access with download option!
Book This Course
  $500.00 Training CD
Free shipment within 7 Working Days, from the date of webinar completion. Get life time access for unlimited participants.
  $600.00 Flash Drive
Free shipment within 7 Working Days, from the date of webinar completion. Get life time access for unlimited participants.
For multiple location please contact our customer care team +1-510-857-5896.
Do you want to Host
this webinar at your Organization!
Call us at +1-510-857-5896
Email us at webinar@onlinecompliancepanel.com
Minimum 10 attendees
How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
John currently works for the Biologics Consulting as a Senior Consultant. John served as a Senior Review Biochemical Engineer and Lead cGMP inspector in the Division of Manufacturing and Product Quality at CBER, FDA. He contributed to formulation of FDA policy and guidances. John has provided advice to industry on regulatory strategies, pharmaceutical product facility design, best practices, and cGMP compliance approaches that meet FDA licensing requirements. John received his B.S. in chemical engineering from N.C. State University and his M.S.E. in biochemical engineering from Johns Hopkins University.


View More