Quality system requirements for cleaning, maintenance and calibration programs

Duration: 90 Minutes
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.
Maintenance Programs
Instructor: Kenneth Christie
Product ID: 500283

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
How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Kenneth Christie has over 30 years of sterile manufacturing and regulatory GMP consulting experience in the areas of Quality Assurance and Validation Management in the pharmaceutical and biotechnology industries. Mr. Christie is currently the Chief Operating Officer for VTS Consultants, Inc. located in Amherst, MA. Specifically, his responsibilities include quality system auditing, GMP training, and serving as a subject matter expert for aseptic manufacturing processes, medical devices and solid dosage processing equipment, utilities, and systems on a global basis. Mr. Christie also performs vendor audits, site pre-approval inspections and assists clients with addressing and correcting regulatory observations.

Prior to joining VTS, Mr. Christie was the Validation Manager at Parke-Davis' Sterile Products Facility in Rochester, MI. While there, he was involved in the review and approval of all facilities, equipment, and system commissioning/qualification activities. Additional responsibilities included routine interaction with the FDA and European inspectors (EMEA), corporate management and third party contract-manufacturing representatives to defend validation practices and to assure regulatory compliance for the manufacture of aseptically produced products.

Mr. Christie is a speaker and trainer for several professional organizations in the US, Canada, Europe, and Asia and is a published author of several articles dealing with the challenges of aseptic processing. Additionally, Mr. Christie served as a member of the ISPE’s Professional Certification (PCC) Commission as an Examination Development Committee (EDC) member.

He possesses a BS degree in Biology from Shippensburg State University (PA) and an Executive MBA degree from Michigan State.
View More