OPTIMIZING PHARMACEUTICAL OUTSOURCING
August 18-19, 2014
Day 1: 1:00 – 5:15 | Day 2: 8:30 – 5:00
Selecting the Right Partner for Your Business and Getting the Most Out of the Relationship
Instructor: Trevor Deeks Ph. D., Principal, Deeks Pharmaceutical Consulting Services LLC
This seminar will cover the outsourcing of a broad range of pharmaceutical activities, including manufacturing, process development, analytical development, product testing, stability testing, potency testing, cell bank manufacturing and testing, cell bank characterization, protein characterization and research. It is aimed at any pharmaceutical company that has a need to outsource any or all of its activities, but will be particularly relevant to smaller companies that do not have the resources and expertise of larger companies, but which will need to depend heavily on reliable, experienced and technically competent third party contractors.
In addition to providing some guidance on how to identify and evaluate third party candidates, this seminar will also cover how to assess technical competency, quality and compliance, how to obtain proposals and select the candidate that best meets the companies’ needs, how to develop Commercial and Quality Agreements and how to manage the third party relationship to maximize the benefit for both parties. It will describe a set of tools that will help the company to manage outsourcing activities.
This seminar is not intended to provide high technical content but technical specialists as well as project managers will benefit from what the seminar has to offer. It will provide learning via both presentation material and via group workshop exercises and other interactive methods.
• Identification, assessment and selection of third party contractors based on competency and quality
• Selection based on the needs of the contract giver – finding the right fit and aligning the cultures
• Quality audits and quality agreements – best practices
• Legal aspects and agreements
• The perspective of a virtual company
• Outsourcing manufacturing, process development and analytical development activities
• Manufacturing and characterization of cell banks
• cGMP manufacture of bulk drug substance and final drug product
• Product release testing and product characterization- what makes sense to outsource
• Commercial manufacturing agreements and developing long-term partnerships
• Outsourcing of other services (qualification, validation, IT services and consulting)
• Tools for managing outsourcing activities
• Project management – contract giver and contractor perspectives
Dr Deeks has 35 years of experience in pharmaceutical manufacturing, process and formulation development, QC and QA experience. He has developed broad technical expertise and has been involved in the commercialization of a number of currently marketed products.
He has held management roles with major pharmaceutical manufacturing and development companies and has also managed pharmaceutical consulting groups providing auditing, validation, GMP consulting, QA and contract Qualified Person (QP) services.
He is a QP registered in the UK under the provisions of the EC Directive. He has audited and assessed more than 50 contract service providers, globally and has worked with CMOs and CTLs for 25+ years.
He recently led a contract manufacturing group for a medium-sized pharmaceutical company for 4 years, identifying, assessing and negotiating with contract manufacturing organizations (CMOs) and contract testing laboratories (CTLs). During this time he developed systems and tools for identification, selection and management of CMOs, CTLs and contract packaging organizations (CPOs).
He has taught several training courses and workshops for PDA, ISPE, PTI and in-house for pharmaceutical companies as well as being an active presenter at PDA, ISPE, AAPS, Pharmaceutical Society and independent conferences.
He has published over 30 papers in peer-reviewed journals and several books and book chapters. Most recently he was lead editor and an author for a new book entitled Pharmaceutical Outsourcing: Quality Management and Project Delivery, now available through PDA Publications.