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FDA has held four supply chain conferences since September 2008; At every possible public forum FDA announces that supply chain is top of their agenda. US Congress is passing legislation that will affect all importers and President Obama is following developments and FDA oversight on this matter. The EU is in the process of updating its legislation with respect to counterfeit drugs, importing and Good Distribution Practice. Supply chain is the hottest regulatory issue of the moment.
Many established companies believe that they have an adequate handle on their supply chain because “we haven’t had a recall in three years.” Is that a sufficient indication and could your company be the next to have to make that dire announcement. Are you wasting resources on rejects and quality failures without fully understanding the problem. Remember the four “M’s” –“materials” is one of them and is also one of the six quality systems inspected by FDA. This two-day course will take an in-depth look at hazards associated with starting materials and components of drug products, using formal risk management tools to prioritize the threats to your supply chain and will show you where to focus your quality efforts.
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Benefits to the Participants
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As the global Heparin recall unfolded during 2008, regulators around the globe started to question whether industry was being sufficiently diligent in managing its supply chain. A new paradigm was created whereby regulators acknowledged that they simply do not have the resources to ensure the integrity of the supply chain and in any case this should be your concern: your products are the ones that will counterfeit or contaminated. This course will provide you with the know-how to approach your supply chain in an aggressive manner whereby you challenge current assumptions and create new rules of engagement.
If you are working in purchasing, logistics, operations, production, Quality Assurance, Quality control or any other quality function, compliance, regulatory affairs and for those of you in product development who are responsible for early stage selection of suppliers, you simply cannot afford to miss this course.
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Issues to be covered
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Essential topics:
- Review of threats to supply chain integrity: rogues or rascals: deliberate or negligent
- Review of current global quality initiatives for supply chain integrity:
- 21 CFR part 211
- EU GMPs and proposed revisions
- ICH Q7
- WHO, IMPACT, GDP guidance and PIC/S
- IPEC, USP, EDQM and European Pharmacopoeia
- Recent recalls
- What can you do:
- Identifying links in the chain and using risk assessment to find the weaker links
- Measures to strengthen the chain
- Eliminating the middlemen
- Certificate of Analysis: what does it mean
- Questionnaires, on-site audits and vendor assessment programs
Learning Keys:
- Become familiar with regulations and guidance in this critical field
- Learn to distinguish the different links in the chain: manufacturer, supplier, agent, broker, repackager etc.
- Understand the genuine risks to your company’s supply chain
- Perform risk assessments to identify, quantify and prioritize risks for:
- Active Pharmaceutical Ingredients (API, drug substance)
- Inactive substances (excipients)
- Components: container closure systems and auxiliary materials
- Understand how analytical controls can be used to help design controls into raw materials at an early stage of product development
- Learn how to perform effective supplier and manufacturer audits in a limited time frame
- Learn how to monitor, evaluate and improve supplier performance
Interactive Elements
This is a workshop and not a lecture series. Be prepared to think and interact with colleagues from other companies, benchmarking and gaining the added advantage of their experience. The course presenter, Karen Ginsbury has been described as having "a highly engaging style of presentation" and interacts with the audience throughout. An experienced workshop facilitator, Karen will summarize the outcomes of the workshops and e-mail them to participants so that the interactive sessions are captured for you.
Questions are welcomed and addressed both on real-time as well as at dedicated sessions at the end of each day.
Group Activities
Interactive exercises in small groups will be performed as follows:
- dentifying risks in the supply chain – developing an Ishikawa diagram
- Translating the Ishikawa into an FMEA asessment
- Using the FMEA to develop a materials control strategy
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Who should attend
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As the global Heparin recall unfolded during 2008, regulators around the globe started to question whether industry was being sufficiently diligent in managing its supply chain. A new paradigm was created whereby regulators acknowledged that they simply do not have the resources to ensure the integrity of the supply chain and in any case this should be your concern: your products are the ones that will counterfeited or contaminated. This course will provide you with the know-how to approach your supply chain in an aggressive manner whereby you challenge current assumptions and create new rules of engagement.
If you are working in purchasing, logistics, operations, production, Quality Assurance, Quality control or any other quality function, compliance, regulatory affairs and for those of you in product development who are responsible for early stage selection of suppliers, you simply cannot afford to miss this course.
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About the Speaker
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Karen Ginsbury, B.Pharm, M.Sc, MRPharmS, has over twenty years of experience in the pharmaceutical industry. With a Bachelor of Pharmacy degree from the University of London (“The Square”) and a Master of Science in Microbiology from Birkbeck College, University of London, Karen started off with a well-rounded foundation in the basic skills appropriate to the pharmaceutical industry. She has worked in industry for most of her career, initially in Research and Development at Smith and Nephew in England and then for seven years at Teva Pharmaceutical Industries, today the world’s largest generic manufacturer. After leaving Teva, Karen set up her own consultancy company, PCI Pharmaceutical Consulting Israel Ltd which has been providing services to the pharmaceutical industry worldwide for the past 14 years. PCI regularly works with pharmaceutical, biotech and API manufacturers to assist them in resolving compliance issues with regulatory authorities, in setting up, maintaining and upgrading or improving their quality systems, performing audits at vendors, contract manufacturers, laboratories as well as helping clients successfully prepare for FDA, Health Canada, EU and local regulatory inspections.
Karen was responsible for setting up the compliance department at Teva and published a book on compliance auditing, still available in the USA, that was purchased by most of the multi-national pharmaceutical companies as well as by the US FDA.
Karen regularly lectures around the world on quality topics and is renowned for her lively and engaging style of presentation. She was winner of the Institute of Validation Technology’s “Presentation of the Year Award” in 2006 and their “Webseminar of the Year Award” in 2007.
Karen is also an active volunteer in the Parenteral Drug Association (PDA) and is currently co-editing their Technical Report on GMPs for Investigational Products.
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