Read Frequently Asked Questions
Vendor Qualification - Designing and Implementing an Efficient and Compliant Vendor Program
This vendor qualification training will provide valuable assistance on how to avoid costly regulatory action from agencies when they inspect your facilities in pharmaceutical and biotech industries and find deficiencies in your vendor qualification programs. It will show you how to assess your systems and bring them into compliance.
Why Should You Attend:
This webinar will provide valuable information on the regulations of the USA, Canada and the EU as they apply to your management of vendors of services and materials and how the agencies are changing their interpretations. We will examine successful workable processes that are compliant with the regulations and yet efficient from a business perspective, and show how companies meet these stringent regulations.
The incorporation of risk management into the development and execution of the program will be highlighted for clinical as well as commercial products, irrespective of whether they are manufactured within your own plants or in your contract manufacturer's facilities. You will also see how companies run foul of the agencies resulting in warning letters as the agency steps up interpretation and enforcement and how from this information you will be able to assure that you do not suffer the same fate.
Areas Covered in the Seminar:
- What the elements of a vendor qualification program are?
- What regulations govern the vendor qualification program?
- How the agencies are reinterpreting the regulations and enforcing them more stringently?
- How to develop and implement a program that is both compliant and efficient - a tiered program?
- What a compliant program looks like to the agency in this time of increased enforcement?
- How to incorporate risk management into the vendor program so you can focus your resources in the most vulnerable areas?
- The different challenges and how to manage them in the clinical trial and commercial stages.
- What the agencies expect from you to convince them you are in compliance and in control?
- How to manage vendors and contract manufacturers?
- Where companies go wrong and get into regulatory hot water and how to avoid it yourself ?
Who Will Benefit:
This webinar will provide valuable assistance to all in pharmaceutical and biotech industries who manufacture products for clinical and commercial uses. The employees who will benefit include:
- QA staff and management
- Regulatory Affairs staff and management
- QC staff and management
- Compliance auditors
- Manufacturing management
- Project managers working in the CMC arena
- Senior managers and executives
- Process scientist and management
- supply chain and logistics managers
Peter Calcott , Ph.D. is founder and President of Calcott Consulting which serves the biotech, pharma and venture capital industry. It provides consulting services in supply chain, quality systems, clinical development, regulatory affairs, compliance and governance, enterprise e-solutions and government affairs. It also provides corporate strategy development, analysis and assessment especially due diligence evaluation.
He has held positions in industry in all these disciplines over a 30 year career. He has presented at national meetings and is active in the biotechnology community via BIO and the bay area BayBio trade associations where he is chairman of the BIO RAC committee and a Board member of BayBio.
The selection of service or material providers is an important step in the manufacturing process whether it be the selection of a contract manufacturer, a testing laboratory or a supplier of raw materials or components. In addition, the reasoning for the choice and its documentation are equally or even more important. As agencies try to improve the risk profile of products, they have reinterpreted regulations and are enforcing them more stringently. However, this is often overlooked or poorly documented by companies as evidenced by the large number of Warning Letters and regulatory actions taken by regulatory bodies worldwide over the last 18 months.
After selection of the provider, it is critical that the company constantly assess the performance of the provider during the life of the relationship to assure that their product is not adversely affected by the quality of the service. These periodic reviews must be documented and be available for the regulatory body to examine to assure compliance. With the increased enforcement by agencies, this area poses a particularly high risk area for companies particularly if they are not vigilant.
ComplianceOnline would process/provide refund only if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs."
For substitution, please email firstname.lastname@example.org or call +1-650-620-3937.
This training hasn't been reviewed yet.
Process Validation, planning, strategy, requirements, risk assessment, design description How to prepare for the unannounced FDA compliance inspection Quality by Design: what the FDA wants, what you must do, how you can deliver to their expectations and what relief you can expect Preparing for FDA Pre-Approval Inspections