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73 results of "Life Sciences x" and "Biotech & Biologics x"
Live Webinar

Device Changes and the 510(k) – Hardware and Software

This webinar will evaluate two recently published U.S. FDA Guidance Documents on device changes: 1) “Deciding When to Submit a 510(k) for a Change to an Existing Device Final Guidance for Industry and FDA Staff”; and 2) “Deciding When to Submit a 510(k) for a ...

Live Webinar

Stability Studies and Estimating Shelf Life with Regression Models

Manufacturers of foods, drugs, consumer goods, and other products must determine the shelf life of their products so that customers know when the product can be expected to perform as intended. Many approaches are available to quantify the "shelf life" and the ...

Live Webinar

Acceptance Sampling for Process Validation and Production Lot Monitoring

Personnel involved in process validation and production control often rely on sampling methods to determine the suitability of a process before moving to production (process validation) or for checking production lots for acceptance. This webinar provides deta ...

Live Webinar

The Human Error Tool Box: A Practical Approach to Human Error

Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage. From p ...

Recorded Webinar

Understanding Initial IND Submission- The first 30 days

This webinar will shed light on the entire process that takes place from the time the sponsor submits the initial IND to the FDA for initial 30-days. Alongside this presentation would detail the various grounds on which the FDA may consider placing a clinical ...

Recorded Webinar

Review of Chemistry, Manufacturing and Controls (CMC) of an Investigational New Drug Application (IND)

Outline of the relevance of information from the CMC perspective Understanding differences between small molecules and Biologics Glimpse of CFR 312.22 with the highlight on the FDA’s primary objectives in reviewing an IND Overview of Pre-IND activities C ...

Recorded Webinar

Technical Writing for the Pharmaceutical, Medical Device and Biotech Industries

This technical writing training program will offer attendees an understanding of how the reporting process supports products in research, development, and in the marketplace. This virtual session will highlight the mandates for documentation set forth by the r ...

Recorded Webinar

EN/IEC 62304 - Is your Medical Device Software Out of Compliance?

This course is essential for Medical Device and IVD companies interested in submitting software enabled medical Devices or Software as a Medical Device to the FDA for 510K approval. One of the biggest risks most company's face when submitting their device for ...

Recorded Webinar

US FDA’s 2019 - 2020 Strategic Priorities

In their latest strategic priority cycle, the FDA has committed to reduce the time and cost required to bring a product to the U.S. market and support it throughout its life cycle while not compromising reasonable assurance of safety and effectiveness. To achi ...

On-Demand Webinar

CAPA Under U.S. FDA / CGMPs and EU MDR / ISO

CAPA, Corrective and Preventive Action, is a major element of cGMP compliance, and one of the four key areas of a medical device QSIT inspection. CAPA is a key source of regulatory problems. The primary areas for CAPA focus. The roles of Failure Investigation ...