• Site Info
  • About PCS
  • About Ian Sykes
  • About René Maassen
  • About Wilma Meijs
  • About Jaap Koster
  • Customer Profile
• Training Services
  • External Training
  • In-House Training
• Cooperation
  • Facilities
  • Equipment
  • Training
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• Contact

 

Training

It is a requirement of current Good Manufacturing Practice (cGMP) that staff are provided with not only the appropriate technical training to enable them to perform their role correctly, but also training in the theory and practice of GMP. Moreover, both volume 4 of the EU Guide to Good Manufacturing Practice and part 211.25(a) of title 21 of the Code of Federal Regulations explicitly state that training must be provided on an ongoing basis and regularly assessed.

Development and Delivery

HPCS, through their long, practical involvement with the pharmaceutical industry are able to develop and deliver appropriate training packages which will satisfy this basic GMP requirement.

Our network of experts encompasses many disciplines (scientists, engineers, validation, auditing, laboratory and regulatory staff), which enables us to develop and deliver tailored packages to meet the client?s training requirements for all levels of the organisation.

HPCS training courses range from publicly-available, hotel-based courses covering a range of technical and cGMP subjects to "in-house" training packages tailored specifically to the client's requirements, which can be delivered either at the client's premises or other suitable venues.

Training Requirements Matrix

HPCS can assist with the development and definition of training requirements matrices, ranging from technical training to broader pharmaceutical training, including:

• current Good Manufacturing Practices (cGMP)
• Good Development Practices (GDP)
• Good Laboratory Practices (GLP)
• Good Engineering Practices (GEP)
• Good Distribution Practices
• Validation
• Auditing and self-inspections
• Stability Testing.

Competency Assessment

Competency assessments are included with HPCS training packages and a number of operator-level courses are offered with accreditation from external educational agencies. This approach allows staff to acquire evidence of ongoing professional development with a flexible, "matrix approach" to learning, which can lead, if desired, to an industry-recognised qualification.