Critical Process Cleaning and Cleaning Validation

The Center for Professional Advancement
Burlingame, Isla Verde, United States

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

Course Description:

'' This course will provide a solid overview of the principles and technology of residue removal and residue measurement on product contact surfaces. It will address the latest issues, industry practices and compliance strategies regarding choice of cleaning techniques, cleaning agents, analytical methods, residue challenges, grouping strategies and validation protocols. Examples of current industry cleaning validation practices and case histories will be presented. Recent FDA inspection history and regulatory comment regarding these issues will be discussed in depth.

This practical course will help participants familiar with this topic to better evaluate and develop their own FDA regulated cleaning programs that balance production objectives against QA/validation objectives. The idea is to first achieve an effective reliable cleaning process, then generate sufficient data and justification without going overboard on the number of samples, the number of analytical tests and the number of qualification studies that have become an excessive burden to many firms.

Participants are encouraged to bring a cleaning problem to the course for inclusion in the ¡°Participant Problem Clinic¡± on the second day.
...''

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: Burlingame, Isla Verde
Houses & Roommates: Burlingame, Isla Verde

Clinical Protocols
Hair Product Development
Preparing for and Surviving an FDA Inspection
cGMP Auditing - Strategies for Compliance
Patent Law
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
cGMP for Pharmaceutical Production Supervisors
Good Laboratory Practices (GLP)
Emulsion-Suspension
Aerosol Technology
Process Analytical Technology
Color Additives and Their Use in Decorative Cosmetics
Industrial Drying of Heat Sensitive Materials
Powder Mixing Technology
GMP for Dietary Supplements

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