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Date On Request

Active Pharmaceutical Ingredients - QP Module

United Kingdom, Newcastle upon Tyne

Entrance: £2,880.00 (excl.VAT)

Lunch: included
Multiple delegate discounts available. Discounts also offered to NHS staff, regulators and charities.
Targeted audience: Aspiring Qualified Person Pharmaceutical Technical Professional
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Course overview :

This course gives a unique insight into the regulatory expectations associated with producing both chemically synthesized APIs and biological/biotech APIs. Delegates will practice interpretation of the key API regulations and see them in operation during visits to two API manufacturing facilities. This course fulfils the requirements of the Qualified Person Study Guide and we don’t just train to pass a viva, we take the time to prepare you for your career ahead. The course also provides insight and expertise on managing global API supply chains, vendor quality assurance and “how to audit” API facilities. This course is also RSC Approved.


Key Learning Objectives :

As API supply chains become ever more diverse and cost pressures more acute, the pharma manager needs a keen appreciation of risk factors, design, control and monitoring of API sources. This course allows delegates to differentiate between natural variation and risk across a range of API processes, indicating the most appropriate and proportionate actions to take to mitigate any areas of concern.

It provides practical guidance on the key responsibilities of the Qualified Person when approving a GMP declaration. You will also learn:

  • How to meet 2004/27/EC
  • How to audit and provide QA of excipients
  • How to manage change of API source
  • How to compare the requirements of chemically synthesized APIs and biotech products
  • How to audit and how to provide oversight of remote or contract manufacturing capabilities

It will also allow you to make informed decisions when faced with a range of GMP non-conformances during API synthesis.

Our detailed educational material grows into a lifelong reference library.

This course is approved by the Royal Society of Chemistry as suitable for their members’ continuing professional development.


Course Content :

For both chemically and biologically produced APIs, the course includes:

  • Common process steps and their effect on the quality of the final drug substance
  • EU and US regulatory requirements
  • Comparison and contrast of API facilities
  • How GMP is implemented across the key production processes
  • Common sources of GMP non-conformance and adulteration or misbranding
  • Vendor assurance, management of supply chains and auditing of facilities by QA or QPs – scope, execution and follow-up of audits
  • Two visits to state-of-the-art facilities and discussions with on-site pharma professionals (API and Biotech)

We provide an optional post-course assessment.



Registration link :

  • NSF Online registration : Link

NSF contact :

Note : 

  • All of our courses can be brought on-site, tailored to your key concerns and delivered at a time that suits you.

Course outline :

Active Pharmaceutical Ingredients

  • The Regulations
    • EU and US regulations and guidelines
    • Drug Master Files and Certificates of Suitability
    • Key GMP guidance – ICH Q7
  • Manufacturing Processes and Quality
    • Key issues for…
      • Synthesis
      • Purification and impurity control
      • Packaging
    • Process Validation
  • Supply Issues for the Dosage Form Manufacturer
    • Supplier selection and audit
    • Supply chain integrity
    • Technical Agreements
    • Certificates of Analysis

Bulk Biologicals and Biotech Products

  • What is a Biological or Biotech Product?
  • EU and US Regulatory Aspects
  • Essential Characteristics of Biologicals
    • Antibiotics
    • Vaccines
    • Blood products
    • Monoclonal antibodies
  • Quality Aspects
    • Control of starting materials
    • Control of cultivation, harvest and purification
    • Analytical and bioassay techniques

Excipients

  • Regulatory Environment
  • GMP Guidances/Codes
  • No picture

    John Johnson

    Executive Director

    FRSC, CChem, MIQA

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Resume

John Johnson is passionate about helping organizations foresee and overcome the barriers to sustainable long-term growth. He brings 28 years’ experience across a range of companies in the pharmaceutical and healthcare industry. He has worked in small, medium and large pharma biotech companies across the product lifecycle for a wide range of dosage forms. He has senior operational and corporate-level experience in operations and quality assurance and has led multinational companies in strategic projects associated with:

  • Inspection readiness and remediation (in UK, Italy, France, Australia, Singapore, India and USA)
  • Crisis management including handling of regulatory authority actions, multinational recall and import bans
  • Major culture change to improve customer service, quality, cost or “on time in full”
  • Installation, monitoring and periodic effectiveness checks on site or company quality management systems
  • Paradigm shifts including downsizing, upsizing, mergers and acquisitions
  • QP development, training, mentoring and resource management
  • Lean projects in QC laboratories and OSD facilities
  • Management review and escalation processes from shop floor to boardroom level

Mr. Johnson has used research with subject matter experts from Toyota and Tata to help firms streamline and simplify complex processes and procedures to reduce cost, rework, rejects and human error. By working with a range of companies across a variety of cultures, dosage forms, business plans and geographies, he has acquired a style that has a proven methodology yet is easily tailored to suit the particular need.

A QP since 1995 and a QP Assessor since 2005, he has been a sponsor and mentor for QPs, some of whom are QA department leaders. As a Fellow of the Royal Society of Chemistry, he is laser focused on the value that good analytics bring to batch dispositioning decisions and has a particular expertise in data-based, quality risk management.

Utilizing a range of development tools and techniques, Mr. Johnson has been responsible for developing quality and operational teams to be aligned and engaged with the company’s strategy so that the team’s combined output is driven by a performance culture that is self-governing yet capable of constant re-analysis and refreshment. He has also written articles for a variety of pharma publications.

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