Active Substances and Excipients Training

This Active Substances (AS) and Excipients training course gives a unique insight into the regulatory expectations associated with producing both chemically synthesized and biological/biotech ASs. The course also provides insight and expertise on managing global AS supply chains, vendor quality assurance and “how to audit” AS facilities. We summarise the key steps in identifying and removing impurities, including some updated information on the impact of potential nitrosamine formation. During the course we will also visit Active Substance manufacturing facilities to see how the theoretical requirements are implemented in real life.

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.

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

As AS 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 AS sources. This course allows delegates to differentiate between natural variation and risk across a range of AS processes, indicating the most appropriate and proportionate actions to take to mitigate any areas of concern.

You will be provided with an overview of the EU and US regulatory framework surrounding active substance and excipient manufacturing process and be given practical guidance on the key responsibilities of the Qualified Person when approving a GMP declaration.

You will also learn:

• How to meet EU and US Regulatory requirements and GMP guidance
• The major differences between chemical synthesis and bioprocesses; and contrasting both against drug product formulation
• How to manage change of AS source
• How to audit and provide QA oversight of excipients and Active Substances

The course will also allow you to make informed decisions when faced with a range of GMP non-conformances during AS production.

Our detailed educational material grows into a lifelong reference library.

For chemically synthesized and biological/biotech 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 AS facilities
• How GMP is implemented across the key production processes from AS starting materials through to packaging and distribution
• Vendor assurance and management of supply chains including auditing of facilities

Active Pharmaceutical Ingredients

• The regulations
  • • EU and US regulations and guidelines
    • Active Substance master files and certificates of suitability
    • Key GMP guidance –EudraLex Volume IV Parts 2 and 4 and Annex 2
  • Manufacturing processes and quality
    • Key issues for:
      • Synthesis
      • Purification and impurity control
      • Packaging
  • Supply issues for the dosage form manufacturer
    • Supplier selection and audit
    • Supply chain integrity
    • Technical/quality 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
• Premises and Facilities
• Quality aspects
  • Control of starting materials
  • Control of cultivation, harvest and purification
  • Reducing risk of viral contamination
  • QC Strategy for Biopharmaceuticals

Excipients

• Regulatory environment
• GMP guidances/codes

The Aspiring Qualified Person

• Our training is generally considered as the best available and our QPs are held in high regard within the industry
• In addition to being accepted in the UK, our training courses are well known and accepted by several EU countries, including Ireland, The Netherlands, Austria, Hungary and Malta
• You are more likely to become a QP with us than with any other training provider!

The Pharmaceutical Technical Professional

• Not all people attending these courses intend to become QPs. Many use the training to develop as technical managers within other areas of pharmaceutical manufacture and control
• Many industry professionals from a range of disciplines attend the courses as part of their continuing professional development. Taken with some of our other QP modules, this course is designed to lead to postgraduate certificate, diploma and MSc qualifications

Course tutors will be selected from the following:

David Waddington – David’s career in the pharmaceutical industry spans more than 30 years in various quality roles for three major international pharmaceutical organizations. Dave is eligible to act as a Qualified Person under the permanent provisions. He has broad experience in QA and manufacturing management gained through working with a wide range of dosage forms for global supply, including solids, liquids, sterile products, food supplements and natural products.

Neil Wayman – Neil is an experienced quality professional with over 30 years of experience in pharmaceutical quality. Neil has worked as a QP and RP and has experience of Stability testing and the manufacture of APIs , solid oral dose and sterile injectables (terminally sterilised and aseptic). Neil has extensive experience managing all aspects of manufacturing site and global quality management systems, including inspection/audit management, issue management and site remediation, as well as global supply chain assurance activities associated with external manufacture and distribution.

Robert Smith – Robert has more than 30 years’ experience in the pharmaceutical industry, in various production and quality roles for a number of major international organizations. He is eligible to act as a Qualified Person under the permanent provisions for both commercial and investigational medicinal products. He is a QP assessor and Vice Chair of the Royal Pharmaceutical Society Panel of Assessors. Robert has broad experience in QA and manufacturing management gained through working with a wide range of dosage forms for both commercial and clinical supply, including solids, liquids, sterile products, vaccines, biological, biotechnology, viral vectors, gene therapy and cellular therapy products.

Ian Pardo – Ian is an experienced Qualified Person who has held Senior Quality Leadership roles for organisations manufacturing both commercial and investigational Sterile, Biologic and Advanced Therapy Medicinal Products. His expertise includes Pharmaceutical Quality Systems, validation, oversight of third-party sites (CMO and in-house), supplier audits/monitoring, establishing supply chains and remediation for manufacturing sites (MIA/MIA(IMP)/MS). Ian has led numerous quality projects, influencing key stakeholders through mentoring and coaching, and succeeding in making organisational changes to meet product, market, and business needs.

Multi-delegate discounts available. Discounts also offered to NHS staff and charities.