FDA Compliance
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How to Identify Leaders Within Your Organization
Identifying and developing talented employees with the potential to become supervisors, department managers and possibly even members of your company’s executive leadership team is a critical aspect of strategic staffing. Developing the ability to identify those with leadership potential... -
How to Prepare a 510(k) Submission
We will explain what a 510(k) is and the procedure to prepare the submission. The several types of 510(k) will be explained. Each part of the submission will be explained. The very confusing concepts of predicate device and substantial... -
How to Prepare for and Host a FDA Inspection and Respond to 483’s
In this webinar you will learn about the types of FDA inspections, preparations such as assigning dedicated personnel to specific tasks for the inspection, facility requirements to support the inspection ( front room, back room), the value of mock... -
How to Prepare for FDA Inspections and Customer Audits of Pharmaceuticals
This webinar will include things that it is important to know about FDA inspections. Using the self-auditing process to correct problems before the FDA or customer arrives will be discussed. How to prepare for an FDA inspection and how... -
How to Prepare Yourself for FDA’s on-going Part 11 Inspection Program
FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years, FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integrity, security... -
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How to Prepare Yourself for FDA’s on-going Part 11 Inspection Program
FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years, FDA issued more than 30 warning letters with Part 11 violations. Citations are related to inadequate integrity, security... -
Sale!
How to Properly Investigate OOS Results
The lack of or Inadequate procedures for handling out of specification (OOS) situations and failure investigations are amongst the most frequently found deviations in FDA warning letters. Most companies have procedures but either they are not adequate or are... -
How to use Quality Systems Inspection Technique (QSIT) to Your Advantage
Large and small medical device companies have a challenge in preparing for and dealing with FDA audits. Quality and Manufacturing personnel in charge of creating and maintaining your quality management system for all of the medical devices manufactured at... -
How to Write a 510(k) in Accordance with Part 807 Requirements
Failure to write an acceptable 510(k), including the formatting and presenting of all the documented evidence to support claims of substantial equivalence can result in endless delays. Delays driven by the agency’s failure to accept or round-after-round of clarification... -
How to Write Effective 483 and Warning Letter Responses
In this regulatory inspection webinar attendees will learn the importance of developing and submitting a robust, timely response to FDA 483 observations or warning letters; as well as, educate the audience on the essential elements of a thorough response.... -
How to write SOP’s for Human Error Reduction
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... -
How Will FDA’s New Approach to CSV Make Implementations Easier?
There is a big shift in the computer system validation (CSV) strategy coming from the FDA. The new methodology and guidance called Computer System Assurance (CSA) could be in place before January 2021. Its focus is taking the principles... -
HPLC Instrument Qualification and Method Validation
HPLC instrument qualification and analytical method validation are two related topics that are essential to compliance in regulated laboratories. This webinar will provide details of current regulatory guidance and examples of best practice in each of these areas. The... -
Human Error Prevention in Pharmaceutical Manufacturing
This webinar will explore the true causes and nature of human error, how human error should be investigated, how human error relates to human performance, and the difference between real human error and systems, process, and management deficiencies. Human... -
Human Factors Usability Studies Following ISO 62366 and New FDA Guidance
This training program will examine how human factors/usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design... -
ICH Q11 – API Manufacturing
The webinar will address aspects of development and manufacture of the drug substance including steps to reduce impurities. By the end of this program, attendees will understand the requirements of the ICH Q11 guidance and learn skills for practical...