What is mentoring? Mentoring is most often defined as a professional relationship in which an experienced person(the mentor) assists another (the mentoree) in developing specific skills and knowledge that will enhance the less-experienced person’s professional and personal growth.

 

 We come to you for your mentoring and training

Why use classroom training in today’s web-based environment?

Today's research professional in a biopharmaceutical company must learn a great deal of new information and learn how to execute highly technical plans and procedures in a short time. Web-based, computer-based, or other forms of individualized learning may make some financial sense in today’s economy and may work for a wide variety of subjects.  However, practical experience shows that during instructor-led classroom training, participants receive immediate feedback and personalized attention, allowing them to master the subject matter more rapidly and completely.  Customized programs aimed at the needed subject matter and to your company's culture will prove to be the most effective.

 On-site Classroom training provides:

 

GXP farma can provide training programs developed from entry-level to experienced personnel in GCP, GMP, and GLP regulations. Training programs are customized to the client’s needs. Training for the most part will be in English but trainers can be native Chinese speakers.  Examples of programs include:

  • Overview of Drug Development

  • Fundamentals of Quality

  • Developing Quality and Regulatory Strategy Plans

  • Developing and Using Target Product Profiles

  • Developing Biosimilars

  • Introduction to Clinical Research

    • Regulations which Affect Clinical Research

    • Detecting Misconduct and Fraud in Clinical Research

    • Regulatory Documents

    • Source Documentation

    • Basic Monitoring Skills

    • Clinical Trial Material / Drug Accountability

  • GXPs from Discovery to Market

  • GMPs for the Workplace

  • Understanding the USP

  • Basic GLPs

    • Laboratory Operations

    • Regulatory Requirements for the Lab (nonclinical, post-approval, and manufacturing)

  • What QC/QA/Regulatory Authority Inspectors look for when inspecting

  • Preparing for a Regulatory Inspection

    • Responding to and Recovering from Compliance Issues

    • How to respond to inspectional issues (FDA 483’s)

    • Practicing for an Regulatory Authority Inspection

  • Vendor Auditing Do’s and Don’ts

  • FDA Interaction, Inspections, and Follow-up

  • How to interact with FDA correctly, right from the start!