83 2014 - Quality system requirements for cleaning, maintenance and calibration programs

Instructor: Kenneth Christie
Description:
This webinar is of importance to industry since the programs listed are some of the basic GMP expectations and found in many regulatory requirements. As a regulatory requirement, preventative maintenance, calibration and cleaning programs are what help assure that the validated state of equipment, utilities and systems remain in a state of control.
The establishment of operational limits are impacted by the successful implementation of such programs and if not properly maintained will adversely impact the final quality results. Important aspects of these programs are their frequency, trending of the results obtained over time, establishment of operational limits and actions to be taken when excursions occur. This webinar will review the regulatory aspects of these programs along with some common deficiencies found during their review by inspectors.
Why Should you Attend:
The qualification of equipment, systems, facilities and utilities are a point in time when testing results meet established acceptance criteria and the item is then released for production use. The establishment and documentation of cleaning, maintenance and calibration programs are what assure a company and auditors that these items will remain in a state of control over time.
In light of trying to reduce operational costs, many companies today contract out these services and often overlook the quality responsibilities they still must perform. Frequencies and results are evaluated over time to verify that are adequate, and to determine if limits need to be revised. Trending of such results help to determine the degree of drift from what was normal and allow companies to possibly extend frequencies to help save time and money. Knowing what auditors find as deficiencies will also allow companies to evaluate their own practices.
Objectives of the Presentation:
Review the current regulatory requirements for these programs
Discuss the items that each program should address
Discuss common deficiencies cited with each type
Discuss questions that attendees may have regarding their current practices.
Who can Benefit:
Quality Assurance
Quality Control
Manufacturing
Production
Regulatory
Laboratory Personnel
Management
Equipment vendors
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