Process Analytical Technology

The Center for Professional Advancement
New Brunswick, NJ, United States

Course Format: Classroom | E-learning | Virtual Class | Online | On-site | Blended | Self-paced

Course Description:

'' Both the US Food and Drug Administration and the European Medicines Agency are pushing improvements in pharmaceutical manufacturing efficiency, defined as Process Analytical Technology, or PAT. These initiatives are driven by increased regulatory demand, consumer pressure and soaring drug dosage costs. The regulatory agencies have identified the test-to-document requirements of the old cGMP mandates as root causes for poor efficiency.

This course establishes a baseline view of pharmaceutical manufacturing and examines PAT from industrial, regulatory and consumer viewpoints. Using case studies, the program demonstrates strategies that help management acceptance and support of PAT programs and provides tactics to avoid pitfalls.

Detailed guidelines for PAT Team formation and management include a five-step plan with milestones. PAT laboratory and testing workflow, with reference to in-process monitoring will help participants transit from theory to practice. Several instrument and sensor segments help form a PAT toolbox, as does a review of chemometrics and statistical analysis. These segments are followed by a PAT validation unit.

At the conclusion of the course, all participants will have a solid grounding in PAT program implementation.
...''

Phone:(732)238-1600

School Address:

Corporate Office
Box 7077, 44 West Ferris Street
East Brunswick, NJ USA 08816-7077
Phone: (732)238-1600
Fax: (732)238-9113
Email info@cfpa.com

Europe Office
Oudezijds Voorburgwal 316A, 1012 GM
Amsterdam, The Netherlands
Phone +31/20/638.28.06
Fax +31/20/620.21.36
Email amsterdam@cfpa.com



Jobs & Resumes: New Brunswick
Houses & Roommates: New Brunswick

INDs, NDAs vs CTDs Global Regulations
Granulation, Tabletting and Capsule Technology
System Validation, GAMP Harmonization and P.A.T
Lyophilization Technology
Pharmaceutical Quality Assurance and Control
Critical Process Cleaning and Cleaning Validation
cGMP for Pharmaceutical Production Supervisors
Good Laboratory Practices (GLP)
Emulsion-Suspension
Aerosol Technology
Color Additives and Their Use in Decorative Cosmetics
Industrial Drying of Heat Sensitive Materials
Powder Mixing Technology
GMP for Dietary Supplements
Starch: Chemistry, Properties and Applications
Atomization, Sprays and Atomizers

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