Training Doyens

OVERVIEW FDA requires that all computer systems used to produce, manage and report on GxP (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. You’ll learn all about how to create and maintain good FDA-compliant documentation using a strategic approach based on System Development Life Cycle (SDLC) Methodologies. The webinar will leave you with the information needed to plan, execute and document a computer system validation effort that meets FDA compliance standards .  You will learn about what must be done to ensure the system remains in a validated state.  In addition, you’ll learn about the various computer system validation deliverables and how to document them through the entire process. WHY SHOULD YOU ATTEND This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodologies when validating computer systems subject to FDA regulato...

Document management plays a key role in successfully managing life sciences content.  A research revealed that one of the biggest challenges faced by life sciences marketers is content overload and the problem is still ongoing. Only 13% of Pharma and biotech marketers and 17% of med tech marketers think they control content properly. Biotech, med tech,  Life Science  and Pharma industries are trying various means and ways to tackle the growing volume of content. But content strategy and objectives are not clear to most of the marketers in the industry. The three challenges of content marketing in life sciences are   1.  Creating the right content by complying with the regulatory environment Marketers struggle to learn how their sales cycle works with that of their customer. Creating valuable content that clarifies all your customers’ questions is vital for positive sales interactions and performance. Together, don’t miss that evolving regu...

OVERVIEW FDA requires that all documentation related to GxP (GMP, GLC, GCP) products be created and maintained in accordance with specific rules. From the color of the ink used to the FDA labeling requirements, you’ll learn all about how to create and maintain good FDA-compliant documentation. The webinar will leave you with the information needed to create and maintain good documentation that meets FDA compliance standards. You will learn about what must be done and what must not be done. In addition, you’ll learn about the validation deliverables for computer systems regulated by FDA and how to document them through the entire process. WHY SHOULD YOU ATTEND You should attend this webinar if you are responsible for any FDA-regulated data and/or records.  All documents need to be created and maintained in accordance with FDA guidelines for good documentation to avoid any issues during an inspection or audit.  You will also benefit from learning about the guidelines...

OVERVIEW In early 2018, the US FDA updated its Premarket Approval (PMA) acceptance process and Refuse to Accept policy for 510(k) submissions. The primary issues that these documents seek to rectify is the number of incomplete and/or inadequate PMAs that are submitted each year and it is the intent of the FDA going forward that they will no longer accept submissions that do not meet their standard of acceptability. This webinar will overview the important critical content of these two revised documents to include the most important checklists that are contained in the Refuse to Accept Policy guidance that provides acceptability criteria for each 510(k) – Traditional, Abbreviated, and Special. The checklists clarify the content needed in traditional, special, and abbreviated 510(k) submissions to allow FDA to conduct a substantive review, thereby enhancing the quality of received 510(k) submissions and improving overall review time. The Acceptance and Filing Reviews for ...

OVERVIEW FDA and U.S. Customs and Border Protection are using new importrequirements. The FDA’s import software screening program (PREDICT) and the U.S. Custom’s ACE software program require more information from the foreign source(s). FDA’s product codes and U.S. Harmonized Tariff Schedule (HTS) link the requirements. Take away is that the software coding information must be correct. Otherwise, you face costly delays and possibly a refusal of the entry. In addition, information on the entry’s commercial or pro forma invoice must be consistent with the information entered into PREDICT and ACE software. All products regulated by the Food and Drug Administration must meet the same requirements, whether imported from abroad or produced domestically. The job of protecting consumers includes an ever-increasing need to oversee imports, which have been increasing by 5-10 percent per year for the last decade, and those percentages expect to keep rising. The FDA continues to change its imp...