• Jeff Kasoff Recorded
    View Anytime
    Duration:60 Minutes
    Price: ¤190.00
    by: Jeff Kasoff
    FDA Inspections - Do's and Don'ts
    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?

  • Jeff Kasoff Recorded
    View Anytime
    Price: ¤190.00
    by: Jeff Kasoff
    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.

  • Jeff Kasoff Recorded
    View Anytime
    Price: ¤190.00
    by: Jeff Kasoff
    How FDA Trains its Investigators to Review CAPA and What you Should do to Prepare
    Year after year, CAPA is the subsystem cited most frequently during FDA inspections. 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 techniques used by the FDA to review your CAPA system. The documents used by FDA to train their inspectors to review your CAPA system will be explained, some of which you may not be familiar with.

  • Jeff Kasoff Recorded
    View Anytime
    Duration:60 Minutes
    Price: ¤190.00
    by: Jeff Kasoff
    How FDA Trains its Investigators to Review CAPA and What you Should do to Prepare
    Year after year, CAPA is the subsystem cited most frequently during FDA inspections. 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 techniques used by the FDA to review your CAPA system. The documents used by FDA to train their inspectors to review your CAPA system will be explained, 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 to increase the likelihood of a positive outcome during the inspection.

  • Jeff Kasoff Recorded
    View Anytime
    Price: ¤190.00
    by: Jeff Kasoff
    Supplier Evaluation and Assessment: How to Meet FDA QSR and ISO 13485 Requirements in a Cost-Effective Manner
    A lack of adequate control over purchases has resulted in a significant number of recalls due to component failures. Since FDA does not directly regulate component suppliers, it is imperative that your company's purchasing and supplier control requirements provide the assurance that only acceptable components are used to manufacture finished devices. Most medical device manufacturers have acceptable systems in place to assure component quality. But what about supplier quality? Your company must have procedures in place that describe the methods you use to evaluate potential suppliers, and set forth requirements that your suppliers must meet to be considered 'approved.' You must also have a system in place to routinely assess your suppliers, and set forth the applicable criteria they must meet to remain 'approved.' You may never have to pay a visit to your supplier if you have a good supplier control program in place.

  • Jeff Kasoff Recorded
    View Anytime
    Price: ¤190.00
    by: Jeff Kasoff
    How FDA Trains its Investigators to Review CAPA and What you Should do to Prepare
    Year after year, CAPA is the subsystem cited most frequently during FDA inspections. 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 techniques used by the FDA to review your CAPA system. The documents used by FDA to train their inspectors to review your CAPA system will be explained, some of which you may not be familiar with.

  • Jeff Kasoff Recorded
    View Anytime
    Price: ¤190.00
    by: Jeff Kasoff
    How FDA Trains its Investigators to Review CAPA and What you Should do to Prepare
    Year after year, CAPA is the subsystem cited most frequently during FDA inspections. 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 techniques used by the FDA to review your CAPA system. The documents used by FDA to train their inspectors to review your CAPA system will be explained, 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 to increase the likelihood of a positive outcome during the inspection.

  • Jeff Kasoff Recorded
    View Anytime
    Price: ¤190.00
    by: Jeff Kasoff
    How FDA Trains its Investigators to Review CAPA and What You Should Do to Prepare
    Year after year, CAPA is the subsystem cited most frequently during FDA inspections. 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 techniques used by the FDA to review your CAPA system. The documents used by FDA to train their inspectors to review your CAPA system will be explained, 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 to increase the likelihood of a positive outcome during the inspection.

  • Jeff Kasoff Recorded
    View Anytime
    Price: ¤190.00
    by: Jeff Kasoff
    Supplier Evaluation and Assessment: How to Meet FDA QSR and ISO 13485 Requirements in a Cost-Effective Manner
    A lack of adequate control over purchases has resulted in a significant number of recalls due to component failures. Since FDA does not directly regulate component suppliers, it is imperative that your company's purchasing and supplier control requirements provide the assurance that only acceptable components are used to manufacture finished devices. Most medical device manufacturers have acceptable systems in place to assure component quality. But what about supplier quality? Your company must have procedures in place that describe the methods you use to evaluate potential suppliers, and set forth requirements that your suppliers must meet to be considered 'approved.' You must also have a system in place to routinely assess your suppliers, and set forth the applicable criteria they must meet to remain 'approved.' You may never have to pay a visit to your supplier if you have a good supplier control program in place.

  • Jeff Kasoff Recorded
    View Anytime
    Price: ¤190.00
    by: Jeff Kasoff
    Complaint Handling in Compliance with FDA and 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.

  • Jeff Kasoff Recorded
    View Anytime
    Price: ¤190.00
    by: Jeff Kasoff
    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.

  • Jeff Kasoff Recorded
    View Anytime
    Price: ¤190.00
    by: Jeff Kasoff
    The FDA Inspection: Preparation, Management, and Follow - up
    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..

  • Jeff Kasoff Recorded
    View Anytime
    Price: ¤190.00
    by: Jeff Kasoff
    FDA Inspections – Do's and Don'ts
    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!

  • Jeff Kasoff Recorded
    View Anytime
    Price: ¤190.00
    by: Jeff Kasoff
    Complaint Handling in Compliance with FDA and 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.

  • Jeff Kasoff Recorded
    View Anytime
    Price: ¤189.00
    by: Jeff Kasoff
    FDA Inspections – Do's and Don'ts
    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!

  • Jeff Kasoff Recorded
    View Anytime
    Price: ¤189.00
    by: Jeff Kasoff
    A CAPA Primer - Elements of a CAPA Program
    A robust Corrective and Preventive Action (CAPA) program is of the utmost importance to a medical device manufacturer. A system that identifies and eliminates nonconformances and potential nonconformances enables both regulatory compliance and cost savings. This session will discuss the importance, requirements, and elements of a CAPA program.

  • Jeff Kasoff Recorded
    View Anytime
    Price: ¤189.00
    by: Jeff Kasoff
    Complaint Handling in Compliance with FDA and 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.

  • Jeff Kasoff Recorded
    View Anytime
    Price: ¤189.00
    by: Jeff Kasoff
    Bulletproof Supplier Management Program
    A lack of adequate control over purchases has resulted in a significant number of recalls due to component failures. Since FDA cannot regulate component suppliers, it is imperative that your company's purchasing and supplier control requirements provide the assurance that only acceptable components are used to manufacture finished devices.

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