Good Engineering Practices in Pharmaceutical Industries

Engineering and Validation
Operations
Quality
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  1. Program Description
  2. Target Level
  3. Description
  4. Objectives and Expected Results
  5. Others Training Materials
  6. Target group
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Duration
3 days (2 days can be customized)
Course fee
-

Program Description

  • Defining the roles and responsibilities of engineers and engineering in the pharmaceutical industry.
  • Covering Good Manufacturing practices in relation to the following areas:
  • User requirements specifications (URS)
  • Factory Acceptance testing and site acceptance testing
  • Risk assessment and qualification requirements
  • Equipment qualifications (Installation Qualification, Operation Qualification, and performance qualification)
  • Retrospective qualification
  • Change control
  • Planned preventive maintenance
  • Unplanned maintenance
  • Employees training
  • Contractors selection
  • Good documentation practices
  • Good Engineering practices in the Utilities and services:
  • Water treatment
  • HVAC
  • Clean steam
  • Risk Assessment of Maintenance Plans
Self-inspection and auditing

Target Level

  • Validation and Qualification scientists, Supervisor and Manager
  • Engineering managers, supervisors, and technical staff both Frontline and support functions.
  • Quality Department (QA, QC, Regulatory and Compliance)
  • Production department.
  • Regulatory bodies involved in pharmaceutical industries.
  • Internal/External Auditors and consultant

Description

Objectives and Expected Results

At the conclusion of this course, delegates are expected to have a sound working knowledge of:

  • Role of engineers in the pharmaceutical industry.
  • Good engineering practices in the pharmaceutical industry
  • Understanding the basic quality issues of engineering
  • Getting an overview of the main utilities and services
  • Understanding the main validation activities and documents
  • Understanding the main engineering activities and documents
  • Developing risk assessment for maintenance plans.
  • Overview of Auditing and self-inspection.
Help networking between delegates

Others Training Materials

  • The course is delivered using a balanced combination of video, presentations, and discussion sessions.
  • The Videos and discussions are focused on putting into practice the techniques covered in the presentations.
  • Delegates are provided with a set of comprehensive course notes covering the presentation material.

Target group

  • -

    Trainer Languages English/Arabic

Sign up

Interested in signing up a group of people for this course?

Please contact our Business Development team:
info@pharmatrixco.com
00962 798756232