PTS - Training, Seminars, and Audits

Training/Seminars

The Principal of PTS has had extensive training and education experience, both professional seminars/conferences and undergraduate college courses. This experience can be applied to your organization in the form of dynamic presentations on general cGMP principles as used in Engineering, Maintenance, and Calibration, for staff or technicians, or sessions tailored to your requirements. Experienced based training can be provided on the following topics:

cGMPs for Engineering, Maintenance, Metrology, and Quality Support Personnel
Engineering Programming (Engineering Integration into the cGMP Environment)
Compliant Calibration Program Management
Compliant Maintenance Program Management
Pest Control and Contractor Qualification Programs
Auditing Techniques (Facilities and Facility Programs and Service Providers)
Calibration SOP Preparation
Maintenance Procedure Generation
Qualification/Commissioning of Process and Facility Equipment

(Other topics can be presented upon request.)

Additionally, Joe Busfield, the Principal of PTS, is a frequent speaker at seminars and conferences for several organizations. The currently scheduled events are listed below, with links to the website of the organization offering the seminar or conference.

Calibration Program Training

The Center for Professional Advancement

Calibration in the FDA Regulated Industry

30 & 31 October, 2008 - Amsterdam, Netherlands

26 & 27 January, 2009 - New Brunswick, NJ

9 & 10 March, 2009 - Dublin, Ireland

Maintenance Program Training

The Compliant Maintenance in the FDA Regulated Industry is available for presentation at your site! Please see this brochure for details.

Compliant Maintenance in the FDA Regulated Industry

Facilities and Equipment Inspection Considerations

The Facilities & Equipment System Component of the Quality System - Inspection Considerations is available for presentation at your site! Please see this brochure for details.

Facilities & Equipment Component of the Quality System - Inspection Considerations

In house seminars and training sessions can be arranged through the organization listed above or by contacting PTS (Training@PTSGMP.com) for customized sessions. In house sessions offer the following advantages:

For a single fee we provide you with access to a leading authority on facility compliance issues.

As few as 3 (or as many as 30) of your technical people can participate in a customized onsite technical training course for a fixed cost plus a small cost per participant for materials that is less than sending you people off site.

The savings on costly hotel and travel expenses for employees is significant. The only expenses for an on site, other than fees, are the reasonable travel and lodging for faculty members.

There is the opportunity to tailor the standard program to your company's specific problems and interests.

Course notes are provided for every participant.

The onsite format ensures that students can interact to get answers to their questions.

An on site session may be the most effective way to keep your organization's compliance skills sharp.

Audits

PTS reviews draw on extensive regulatory, operations, and engineering experience to address issues and avoid regulatory problems or expensive reworking of facilities. You can trust PTS to provide careful and complete reviews of your engineering, maintenance and calibration processes, facilities and facility service providers.

PTS can perform a two week audit of your Calibration, Maintenance, Facilities Control (Pest Control, Engineering Change Control, etc.) or Project Engineering program. PTS has conducted similar assessments for many major and new pharmaceutical, biopharmaceutical and medical device companies. Typically these assessments follow the following pattern:

The first two/three days of the audit are dedicated to reviewing your procedures - both program administration and work performance level (e.g. calibration or maintenance SOPs).
The next two/three days are spent reviewing actual field work performed - the practices. Do they match the procedures and should they?
The last two/three days of the audit are used to review the documentation generated to provide evidence that the work was done as per procedure. This area is often the starting point for a regulatory audit and need to demonstrate a high level of control.
Finally, a report would be created and submitted pointing to areas of concern (if any) and approaches to remediating any deficiencies.

These audits can help prevent regulatory distress or identify opportunities for improvement if a site is already undergoing increased regulatory scrutiny. Please contact PTS at Audits@PTSGMP.com to schedule an assessment of your Calibration, Maintenance, Facilities Control, or Engineering program.