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Training Services

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Quality Compliance Partners, Inc. (QCP)  can assist your training needs by developing a training program in line with current industry practices and regulatory agency expectations.  We provide on-site personnel training for clients such as providing annual GMP training or providing specialized training.

QCP Training Services

Quality Compliance Partners, Inc. offers training in several topic areas. Our courses are designed to maximize the return on your investment by providing lasting, effective training solutions. Our instructors are experienced industry professionals with hands-on experience. We work diligently to design the training and to ensure the level of detail appropriate to your operations.  At the same time, we ensure that you get the quality instructor-student interaction you expect with the course. This interaction allows the training course instructor to answer more specific questions, and gives your employees the individual attention that makes our courses so effective. 

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Custom Training:
Finding the Perfect Fit

Each of our training courses is tailored to fit your company's specific needs. Our course instructor will work with you to create a curriculum that addresses the issues you and your employees face every day. Each of our courses can be delivered on-site at any of your facilities allowing you to cut down on time and travel expenses for your employees. Your employees will benefit from these courses being taught in a familiar environment and having the opportunity to discuss the topics as it applies to your company, in a confidential environment.

 

Examples of training topics include:

  • Annual GMP/GLP/GCP Training

  • Phase Appropriate Quality Systems

  • Data Integrity

  • Roles & Responsibilities in a Virtual Company

  • Management Responsibilities

  • Inspection Readiness - Training of Inspection Response Teams

  • US & EU Regulations- Clinical and Commercial

  • Developing a robust auditing system (e.g. Contract Manufacturers, APU,
    Contract Testing Labs, Secondary Packaging, Distribution Warehouses)

  • Quality Systems Components topics

  • Development of Quality Manuals

  • GAMP

  • Recent Warning Letters -Lessons Learned and Discussion of Applicability
     

            ICH Guidelines

  • Q8- Pharmaceutical Development

  • Q9- Quality Risk Management

  • Q10- Pharmaceutical Quality System
     

            FDA Guidelines

  •  Quality Systems Guidance

  •  OOS Investigation Guidance

  •  Phase I GMPs Guidance

  •  Aseptic Processing Guidance

       

         

QCP Training Services

Other Training Topics

  • Deviations/Investigations/CAPA (how to investigate, document, perform root cause analysis, identify and apply proper preventive/corrective action)

  • Quality Agreements (format, content, points to consider)

  • Supplier Qualification (elements of a good system, points to consider)

  • Product Complaints (elements of a good system, points to consider)

  • Product Recalls (elements of a good system, points to consider)

  • Change Control (elements of a good system, points to consider)

  • Annual Product Reviews (format, content, points to consider)

  • Batch Record Review (how to, key points to consider)

  • Management Review (elements of a good system, points to consider)

  • Label Control Systems (elements of a good system, points to consider)

  • Computerized Systems Training

  • Conducting Audits

QCP Training Services
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