The Webinar will discuss the distinction between and requirements for method validation and method verification, to comply with ISO/IEC Standard 17025:2005 for laboratory accreditation in food/water microbiology. Quantitative and Qualitative methods have different performance measurement requirements and require different statistical analyses. Why should you Attend: Without a clear understanding of the different analytical approaches for verif...

Accelerated aging (AA) is testing that uses aggravated conditions of heat, oxygen, sunlight, vibration, chemicals, etc. to speed up the normal aging processes of items. It is used to help determine the long-term effects of expected levels of stress within a shorter time, usually in a laboratory by controlled standard test methods. Why should you Attend: Accurate prediction of product shelf-life performance is critical to your success. "Do it r...

A timely, well documented, Corrective / Preventive Action program validates a quality system that is not only capable of identifying potential problems but also effectively correcting problems when incidents do occur and as part of the Continuous Quality Improvement program, correcting potential problems prior to occurrence. Adequate incident tracking is the primary foundational element for an effective CAPA system. Why should you Attend: A va...

Come celebrate the union of the PFMEA and the CP! See how the Dynamic Control Plan (DCP) combines both tools into ONE enabling the savings of hundreds of hours of Engineering time, reducing the risk of documentation errors, and, actually improving QMS effectiveness while reducing repetitious work. Why should you Attend: The Dynamic Control Plan (DCP) purely eliminates the stand-alone Control Plan as part of the Advanced Planning and Quality (A...

No or inadequate training of employees is one of most frequently cited deviations in FDA inspectional observations and warning letters. Trainings are either not planned, not conducted, not evaluated or not documented as expected by inspectors. Areas Covered in the Session: GxP training requirements in US and EU Most frequently cited deviations Developing an effective training program for a company, site or department. Who Will Benefit: Trainin...

Medical device regulatory and quality professionals are often responsible for overseeing the development of combination products that include small or large drug "active pharmaceutical ingredients" to achieve the clinical therapeutic effect. In this webinar, you will learn the basics of small molecule and larger molecule (protein chemistry) development and testing. Once a foundation is laid, the discussion will shift to "real world" practical...

The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point". Areas Covered in the Session: U.S. FDA device clearance / approval FDA's and EU's emphasis Product changes and filing a new 510(k) - who's respon...

This 90 minute training course will provide your company the opportunity for comprehensive understanding of the IMPD (Investigational Medicinal Product Dossier) and the structure and content differences between a EU CTA Application and an FDA IND Application. Why you should attend: All sponsors, CROs, Sites and auditors of Clinical Research who are involved in pharmaceutical or biological development need to possess the knowledge and be effici...

The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Real-world examples are provided for how using such sampling plans leads to production of non-conforming product. Why should you Attend: Almost all manufacturing companies spend time and money to inspect purchased parts upon receipt,...

A combination product is a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product. Why Should you Attend: To gain a fundamental understanding of FDA's regulation of Combination Products. Areas Covered in the Session: Definition of combination product FDA Regulatory Pathways Primary Mode of Action User Fees Who Will Benefit: Regu...