Tuesday, March 11, 2008

• $295 Standard fee; $195 Early Bird (before 2/11/08).

Fee includes course materials, handouts, continental breakfast, parking and all applicable state sales taxes.

Payment Terms: Substitutions may be made at any time without additional charge. The registration fee, less 20%, is refundable if written notification is received at least 2 weeks prior to the program. For cancellation within 14 days prior to the course, 50% of the registration fee is refundable. If course materials such a books have been sent to course participants in advance, the cost of that material will be subtracted from the refund. "No shows" are subject to the full fee.

UCLA reserves the right to postpone an offering 7 days prior to the course date should minimum enrollment requirements not be met. If a program is canceled, you will be notified and your registration fee will be refunded in full, less the cost of course materials sent in advance if they are not returned in the condition in which they were received. The liability of UCLA is limited to the course fee.

Manufacturers of medical devices, combination devices, pharmaceuticals, aerospace components, optics, and an array of precision instrumentation must demonstrate, validate, maintain, and document critical cleaning programs and surface quality attributes. Customers and regulatory agencies (notably the FDA) require assurance that surface residue is minimized to achieve reliable, long-term performance. Critical cleaning is essential to contain costs, achieve high quality, increase yield, and maintain a favorable competitive stance. With the increase in miniature and micro products, a high proportion of the device is the surface. Through process descriptions and case studies, students will gain the tools and understanding to select the aqueous, solvent, and “non-chemical” processes most suited to the product. Validation, including cGMP, minimization of interfering and toxic residues, and IEST-STD-1246 will be discussed. Attendees will achieve an understanding and perspective of cleaning validation and contamination control that can be applied to specific critical product manufacture.

Manufacturers of critical devices, high technology products, and miniature/micro components of products for medical, pharmaceutical, military, and laboratory instrumentation. Both final assemblers and suppliers of critical components will find the program to be of value. Job Titles : Manufacturing and Operations Engineers, Q.C. and Validation Engineers, Facilities Managers, Operations Supervisors, Production Managers, R&D Personnel, Product Designers, Safety/Environmental Professionals

7:30 am Registration, Continental Breakfast

8:00 Introduction
Cleaning and contamination control
Why clean?
Critical surfaces

“Use a sharp scalpel”
Options for critical cleaning and contamination control
Cleaning agents
Cleaning action
Ultrasonic cleaning, megasonics
Compatibility
Corrosion
Examples, case studies

Contamination sources
Avoiding contamination

Process selection
Options
Costs
Down-selecting
Testing (in-house and at vendors)
Making the decision
Examples, case studies

Contamination control
Why dirt sticks
Surface quality
Beneficial contamination?
Micro and miniature devices

Regulatory Issues, standards and requirements
FDA
Aerospace/military
Customer-specific
Safety/Environmental

Process validation, monitoring
Detecting contamination
Detection limits
Extraction techniques
Analytical testing
Quality management systems
Writing a cleaning validation protocol
Process control
Troubleshooting
Examples, case studies

Supply chain validation, monitoring, and auditing
When should you outsource?
Examples, case studies

Path forward
The surface is the product
Comprehensive cleaning method validation
Options for productive manufacturing
Making your best decisions
5:00 pm Adjourn

Barbara Kanegsberg, President of BFK Solutions LLC, is a recognized consultant and expert in the field of industrial cleaning and manufacturing processes. She is a founder and ongoing developer of modern industrial contamination control. She has conducted numerous seminars and tutorials and has well over 50 publications in cleaning and contamination control. Barbara is the editor-in-chief of the acclaimed "The Handbook For Critical Cleaning,” CRC Press, 2001 . Barbara Kanegsberg received the 1996 U. S. EPA Stratospheric Ozone Protection Award. She is a member of the University of Massachusetts Lowell Toxics Use Reduction Institute (TURI) Surface Cleaning Laboratory Advisory Committee.

Ed Kanegsberg, Ph.D., Vice President of BFK Solutions LLC, is a chemical physicist and engineer who solves production problems in precision instruments manufacturing. Ed is the associate editor of "The Handbook For Critical Cleaning,” CRC Press, 2001 .

ABIH— 1.0 Safety Certification of Maintenance Points from the American Board of Industrial Hygiene have been applied for.

BCSP — Eligible for .7 Continuation of Certification Points.

.7 Continuing Education Units.