ComplianceOnline

Pharmaceutical Manufacturing Process Validation

Instructor: Rodney E Thompson
Product ID: 700480
Training Level: Intermediate
  • Duration: 60 Min

recorded version

$249.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$500.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This process validation training for Pharmaceutical Manufacturers will allow your process validation program to be executed quickly and efficiently and will ensure that the process validation you perform supports a successful pre-approval inspection.

Description

Successful process validation of a cGMP pharmaceutical manufacturing process is essential for obtaining a commercial license.

Areas Covered in the seminar:

This webinar will cover what one needs to know to set-up and execute successful process validation of a cGMP pharmaceutical manufacturing process. We will examine how integration of the following topics enables surefire process validation:

  • Process attributes, parameters and ranges
  • Process development, process characterization and process scale-up
  • Part 211 requirements
  • EMEA and ICH Guidances
  • Risk analysis
  • Process validation within the overall cGMP validation landscape
  • Integrated process validation documentation
  • Validation master plans
  • Process validation master plans

Who Will Benefit:

All executives, directors, managers and technical staff involved with the execution or review of process validation from the following functions:

  • Product, process and formulation development
  • Project management
  • Analytical development
  • Manufacturing sciences
  • Manufacturing
  • Quality assurance
  • Quality control
  • Regulatory affairs

Instructor Profile:

Rodney E. Thompson, Ph.D., the Founder and President of BioPharm Process Associates [www.biopharmprocess.com] , has 20 years of experience in the biopharmaceutical, vaccine and medical device industries. He specializes in the development of cost-effective, reproducible biotherapeutic and vaccine manufacturing processes; biopharmaceutical process design and process validation; the outsourcing and technology transfer of cGMP-compliant manufacturing technology; system validation and outsourcing contract negotiation. Dr. Thompson has led and contributed to numerous international technology transfer projects at cGMP compliant facilities in both small and large corporations. He has managed the process design and manufacturing implementation for eight different biotherapeutic products in the last 12 years.

Dr. Thompson regularly teaches courses in technology transfer, process validation and the cGMP production of clinical trial material and is a frequent presenter at industry conferences. Previously, he held Director-level positions in process development/manufacturing at Aviron, InSite Vision and Applied Immune Sciences, and performed biopurification process development/scale-up/technology transfer at Chiron, Xoma and Kodak Research. Dr. Thompson received a Ph.D. in chemical engineering from the University of California-Berkeley and graduated first in his class with a B.S. from the Cornell University School of Chemical Engineering.

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Product Reviews Write review

We received your 2 CD's from you and I personally reviewed both. The content is excellent and useful for us to train our QA and lab people.
- Anonymous

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