Jeff Kasoff
Director of Regulatory Affairs, Life-Tech, Inc
Jeff Kasoff, RAC, CMQ/OE, LBB, is the Principal at Lean to Quality, LLC. He has more than 30 years in Quality and Regulatory management. Over that time, Jeff has implemented and overseen quality system operations and assured compliance, at all sizes of company, from startup to more than $100 million in revenue. This multi-faceted experience makes Jeff uniquely qualified to address compliance issues across the entire range of company sizes. Jeff has also been primary liaison with FDA inspectors and notified body auditors, giving him first-hand experience with the most common issues surfaced by regulatory agencies. Jeff has the following certifications: Manager of Quality and Organizational Excellence certification from ASQ, Regulatory Affairs Certification from RAPS, and Lean Black Belt from IIE.
Upcoming Webinar
Compliant Management Controls Under 21 CFR 820 and ISO 13485
The top management of a company is responsible for ensuring that all regulatory requirements are met. This concept is codified in both the QSR and ISO 13485. FDA officials have repeatedly stated that the management controls subsystem is the central subsystem because it is the "glue that holds the quality system together."
Live Session Friday, 23 August 2019, 10:00 AM PDT | 01:00 PM EDT, Duration: 60 Minutes

Recorded Webinar
Best Practices for Preparation for, Behavior during, and Response to an FDA Inspection
This is a detailed course designed to provide medical device/pharmaceutical professionals with the information they require to prepare for and manage FDA inspections. This course provides the rationale, strategies and flow on how to plan for an inspection, the inspection process and approach, and which company roles should be assigned for these types of inspections, among other related topics.
Recorded Session Get life time access for one participant with download option!

Complaint Management: Best Practices to Assure Customer Retention
In this webinar expert speaker, Jeff Kasoff will review the requirements for all the responsibilities related to complaint management, such as defining, documenting, and implementing a complaint-handling system. This webinar will also cover the requirements for all of the above responsibilities. Also included will be a focus on which of these processes impact the customer, and recommended practices to leverage our existing QMS to assure customer retention.
Recorded Session Get life time access for one participant with download option!

FDA Inspection: From SOP to 483
This FDA Inspection process training will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection.
Recorded Session Get life time access for one participant with download option!

Equipment Validation, Tracking, Calibration and Preventive Maintenance
FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment. The program must include: intervals, scheduling, specific procedures, limits of accuracy/precision, and remedial action in the event that the equipment does not meet established requirements. Prior to use, however, this equipment must be validated to make sure it produces product that meets its specifications. There are ways, though, to validate equipment already in use.
Recorded Session Get life time access for one participant with download option!

The FDA Inspection Process: From SOP to 483
This FDA Inspection process training will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection.
Recorded Session Get life time access for one participant with download option!

Process Validation – Principles and Protocols
This validation training will set forth the regulatory requirements for process validation, and will also include definitions and application of applicable terminology, and hints and recommendations for the more common types of process validation.
Recorded Session Get life time access for one participant with download option!

Compliant Management Controls under 21 CFR 820 and ISO 13485
The top management of a company is responsible for ensuring that all regulatory requirements are met. This concept is codified in both the QSR and ISO 13485. FDA officials have repeatedly stated that the management controls subsystem is the central subsystem because it is the "glue that holds the quality system together."
Recorded Session Get life time access for one participant with download option!

Best Practices for Lean Supplier Management in Compliance with FDA and ISO 13485 Requirements
This webinar will review in detail the FDA QSR and ISO requirements for supplier evaluation and assessment, and discuss cost effective options for many of the common practices for achieving compliance.
Recorded Session Get life time access for one participant with download option!

Best Practices in Supplier Management: Evaluation and Assessment
Supplier qualification and assessment is required in both the QSR regulations and ISO standards. Many companies spend a great deal of time and money in pursuit of compliance with this. Many companies can spend much less time and money, and still be in control of their suppliers and in compliance with the regulations. This presentation will review the QSR and ISO requirements for supplier evaluation and assessment, and provide cost efficient, equally compliant options to many of the most common practices.
Recorded Session Get life time access for one participant with download option!

Do's and Don'ts During FDA Inspections
Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions. This session provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection.
Recorded Session Get life time access for one participant with download option!

Complaint Management: Complaint Handling in Compliance with FDA and ISO Regulations
Complaint handling is likely one of the more cross-functional parts of your quality system: Customer Service may receive your customer complaints, Sales and Marketing may need to reach out to the customer for additional information, Regulatory Affairs may determine whether the complaint is reportable, QA may perform the root cause investigation, R&D or Manufacturing Engineering may need to be involved in the corrective action, and Quality Engineering may need to trend the complaints!
Recorded Session Get life time access for one participant with download option!

Equipment Validation, Tracking, Calibration and Preventive Maintenance
This session will review the regulatory requirements for validation, including detailed review of IQ, OQ, and PQ. A sample validation process will be followed through each phase. Documentation requirements for both protocol and results will be reviewed along with a list of pitfalls to avoid in documenting your validation. The importance of the Master Validation Plan will be discussed too. Preventive maintenance will be covered, including how to assure it does not adversely impact validated processes. A cost-effective equipment calibration program will be featured as well.
Recorded Session Get life time access for one participant with download option!

Quality Systems Inspection Technique (QSIT) and How to use it to Your Advantage
Can your organization survive a Food and Drug Administration (FDA) inspection? Are you aware of the different aspects of your business that the FDA will be inspecting? This course, "FDA's Quality System Inspection Technique (QSIT)," is intended to facilitate manufacturer compliance with the FDA's Quality System Regulation (QSR) and related regulations, and increase inspection consistency, product quality, and the efficiency of the enforcement action review process.
Recorded Session Get life time access for one participant with download option!

Complaint Handling in Compliance with FDA & ISO Regulations
Negative customer feedback about a medical device's performance or safety is a strong indicator of whether a firm's manufacturing process is in control. This feedback is therefore subject to many requirements in both the QSR and ISO 13485. Failure to follow up on complaints about medical devices is among the most frequently cited observations on FDA-483s. This session will include the requirements for defining, documenting, and implementing a complaint-handling system, including the requirements for complaint review, investigation, and corrective action, as well as the ISO-specific implications. This session will discuss the best way to document customer feedback, what constitutes a complaint, and what to do with "non-complaint" feedback. Also contained will be a suggested method on including complaint trending into your firm's CAPA program. Additionally, the application of risk management to a complaint handling system will be reviewed, and a specific risk management system will be explained.
Recorded Session Get life time access for one participant with download option!

The FDA Inspection: Preparation, Management, and Follow-up
Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave? The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you're in charge of compliance, usually in the background, and NOW you're in the spotlight, and if your performance isn't good, it's not the show that may close, it's YOUR COMPANY! However, adequate planning, training, composure, and understanding should result in many encore presentations!
Recorded Session Get life time access for one participant with download option!

How FDA Trains Its Investigators to Review CAPA, What You Can do to Prepare Complaint Handling in Compliance with FDA and ISO Regulations
During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will discuss all the documents used by FDA to train their inspectors to review your CAPA system, some of which you may not be familiar with. Also contained in this session will be a section-by-section summary of the CAPA subsection of the QSIT, the document by which FDA inspectors operate during an inspection, as well as how your company can use that same document in your preparation.
Recorded Session Get life time access for one participant with download option!

Anatomy of a Medical Device Inspection: From EIR to 483 to Warning Letter
Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave? The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you're in charge of compliance, usually in the background, and NOW you're in the spotlight, and if your performance isn't good, it's not the show that may close, it's YOUR COMPANY!
Recorded Session Get life time access for one participant with download option!

Best Practices for Purchasing and Supplier Controls in the Medical Device Industry
Supplier qualification and assessment is required in both the QSR regulations and ISO standards. Many companies spend a great deal of time and money in pursuit of compliance with this. Many companies can spend MUCH LESS time and money, and still be in control of their suppliers and in compliance with the regulations. This presentation will review the QSR and ISO requirements for supplier evaluation and assessment, and provide cost efficient, equally compliant options to many of the most common practices.
Recorded Session Get life time access for one participant with download option!

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