Coaching and Mentoring

CBE has supported key management staff from a number of companies, in one-to-one coaching and mentoring in management practices and strategy development.

This coaching and mentoring can take the form of face-to-face meetings and/or distance communications using tools like Skype, teleconferences and emails. The aim of this coaching is to support the individual and provide additional tools for them to become more effective in their role. CBE partners have many years of experience in hands-on management roles, across several different companies and can provide a different perspective to the key individual to further develop their skills and capabilities. Discussions also provide reinforcement of the current approaches as well as providing suggestions for new ones.

Good Manufacturing Practices (GMPs), Quality and Compliance

  • Risk Management Workshop – Practical Application of ICH Q9 and Annex 20 (1 or 2 day course)
  • GMPs Rules for Managers – PICs/TGA/EMA and US FDA – (1, 2 or 3 day courses)
  • Fundamentals of Pharmaceutical Quality Systems (PQS) and ICH Q10 (1 day course)
  • Advanced PQS Elements – PQS Requirements: EMA/PICs and US FDA (1, 2 or 3 day course)
  • PQS Monitoring, Quality Metrics, PQR Rules and Trending Metrics (1 or 2 day workshop)
  • Effective Investigations, RCA, CAPA and Deviations Management (1 or 2 day workshop)
  • Effective Biopharmaceutical Auditing – Regulatory and Internal Audit Programs (2 day workshop)
  • Cross – Contamination in Multi Facilities Workshop (2 day course)
  • Contamination Control and Environmental Monitoring Programs (1 or 2 day course)
  • Supplier Qualification Programs and Supplier Auditing (1 day course)
  • Cleaning Validation Workshop (2 day course)
  • Data Integrity and Data Management – PICs/EMA, WHO and FDA Requirements (1 day course)
  • How to conduct a Gap Analysis for Complaince Upgrades (1 day workshop)
  • Managing Successful FDA Pre-Approval Inspections (1 or 2 day worshop)
  • Preparing for Regulatory Inspections TGA/PICs/EMA and FDA. (1, 2 or 3 day courses)

Technical Courses

  • Good (Control) Laboratory Practices for Pharmaceutical Laboratories (2 or 3 day course)
  • GLPs for Non-Clinical Studies – OECD and CFR 58 Requirements (2 day course)
  • Biological Testing and Bioassay Method Validation (1 day course)
  • Aseptic Processing (1 or 2 day course)
  • Qualification of Aseptic Operators: Dos and Donts in a Cleanroom (1 or 2 day course)
  • Fundamentals of Steam Sterilisation (1 day course)
  • Challenges in Scale Up of Biologics (1 or 2 day course)

Qualification and Validation Programs

  • Validation Principles and Practices – current thinking (1 or 2 day course)
  • Validation Master Planning and Risk Management (1 day course)
  • Introduction to Statistics for Validation – ISPE Course (0.5 or 1 day course)
  • Practical Implementation of Process Validation Lifecycle Approach – ISPE Course (3 day course
  • QbD and Development of CPP and CQA Mapping for Biopharmaceuticals (1 or 2 day Workshop)
  • Computerized Systems Validation – URS through to Protocols (1 or 2 day workshop)

Cleanrooms, Biologics and Vaccines

  • Cleanroom Design and Standards / ISO 14644 Requirements (1 day course)
  • HVAC and Pharmaceutical Services Design Principles (1 day course)
  • Design and Operation of Non Sterile Cleanrooms (0.5 day course)
  • EMS Design (1 day course with workshop)
  • Contamination Control and Environmental Monitoring Programs (1 or 2 day course)
  • Filter Validation (0.5 day course)
  • Biologics Processing: Chromatography and Ultra ltration (0.5 day course)
  • Pharmacovigilance for Biologics and Vaccines (1 or 2 day course)

Customized Courses and Workshops

CBE offers customized course and hands on workshops to suit your needs – please contact us for details.