Supplier Quality Management Training

This interactive, two-day management of suppliers training course equips you with all the tools to develop, implement or improve your pharmaceutical supplier quality management programs.

Using a risk-based approach, we will look at processes for selecting, introducing and maintaining suppliers. These tools will be scalable to your specific business situation. There will be something to learn, no matter what goods and service supply you are involved in. These simple principles can be applied to sterile APIs, calibration services, unbranded cardboard boxes and everything in between.

At the end of the two days, you will leave with the appropriate tools and management skills needed to increase the value of your supply chain and meet regulatory expectations.

Our virtual instructor-led training will be delivered via a combination of live instructor-led virtual classrooms and self-paced learning online. Full details will be sent to you following registration.

By the end of this training, you will be able to:

• Understand regulatory expectations regarding supplier quality management
• Understand the plan, do, check, act cycle of supplier quality management
• Build a cross-functional team to develop business requirements
• Develop tools for initial assessment and supplier selection
• Introduce a new supplier – including approval, putting quality technical agreements in place and collecting regulatory information
• Establish a risk-based audit program
• Monitor and manage supplier performance
• Handle issues and complaints
• Develop an improvement program
• Manage termination of supply
• Contribute to company efficiency and profitability

As supply chains become more and more complex, it is more important than ever to manage third- party suppliers of goods and services as carefully as possible. Regulatory scrutiny of outsourcing in the pharmaceutical industry is becoming more stringent and the responsibility to have sufficient oversight of third parties might seem overwhelming. This course aims to demystify Supplier Quality Management, break it down into simple key components and help you to develop and improve your systems in a way that will ensure that your efforts are not only compliant with GMP, but reduce risk and costs to your business.

• Quality staff responsible for supplier interaction
• Incoming quality control personnel
• QPs either qualified or going through the training program
• Procurement/purchasing staff dealing with raw materials, components, packaging or services

Course tutor will be selected from the following:

Clive Brading – Clive is a former Quality & Compliance leader with more than 40 years' experience from the pharmaceutical manufacturing industry. He has held both site and corporate positions in quality and compliance and has experience of all key dosage forms, particularly sterile aseptically manufactured products. He has experience in the regulatory requirements for all major markets and is an expert in auditing, having previously been in charge of the corporate quality audit team for a large multi-national pharma company.

Lynne Byers – Lynne has over 35 years of experience in pharmaceutical manufacturing management and quality assurance, working for three major international pharmaceutical manufacturers. She is an expert in international QA auditing of a wide range of manufacturers supplying the pharmaceutical industry worldwide and has experience managing QA teams’ in-country affiliates.

Lynne has broad experience with a wide range of sterile and non-sterile dosage forms. She is fully conversant with current EU and FDA GMP regulations and requirements.