Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

Join us for a webinar on April 28 for a discussion of the webinar

Training Overview

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 straightforward proven recommendations how your company can use that same document in your preparation. 

Why Should You Attend

CAPA is the most cross-functional of all subsystems of your QMS. Firms have different CAPA processes which utilize different definitions and terminology for the same meanings. Having advance knowledge and awareness of what to expect during the FDA inspection will drastically assist your firm in the ability to anticipate the inspector’s questions, and how to “translate” your CAPA system into what the inspector is looking for. 

Webinar Takeaway

  • Documents Used by FDA Inspectors
  • Operations Manual (IOM)
  • CAPA Implications, by Section
  • Requirements
  • Recommended Methods of Compliance for Each Requirement
  • CPG Manual 7382.845
  • CAPA Implications, by Section
  • Requirements
  • Recommended Methods of Compliance for Each Requirement
  • QSIT Manual
  • Description of each CAPA Inspectional Objectives
  • Description/explanation
  • Recommended Methods of Compliance

Objectives

  • Understanding of CAPA implications in all FDA Inspection documents
  • Expectation of FDA inspector’s practices
  • Recommended practices to assure compliance with each topic reviewed by FDA inspector
  • How to prepare your team for FDA inspection

Who Will Benefit

This webinar will provide valuable assistance to all regulated companies, since a CAPA program is a requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:

  • CAPA Coordinators
  • Executive Management
  • R&D Management
  • Regulatory management
  • QA management
  • Consultants
  • Quality system auditors


Choose a Purchase Option


$199

Live Webinar - Single Participant 60-mins

You get one log-in for the live 90-minute webinar for one participant, presentation materials and the opportunity to ask questions by phone and email

$399

Live Group Up to 5 Participants

You get 5 log-in for the live 60-minute webinar for all the participant, presentation materials and the opportunity to ask questions by phone and email

$1,025

Live Group Up to 10 Participants + 12 month access

You get 10 log-in for the live 60-minute webinar for all the participant, presentation materials and the opportunity to ask questions by phone and email. 12 month Recorded Access is Included .

$299

Recorded Access Single Participant

You'll have 12 month single user access to log-in for an archived recording of the entire 60-minute webinar, including the Q&A period . You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session

$499

Recorded Access Corporate Group

You'll have 12 month group access to log-in for an archived recording of the entire 60-minute webinar, including the Q&A period . You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session

FDA Faculty Jeff Kasoff

Jeff Kasoff

Regulatory Compliance and Quality Assurance ► FDA QSR, ISO 13485/9001 ► Operational Excellence -Remote Consultations

York, Pennsylvania, United States

Jeff Kasoff, RAC, CMQ/OE has more than 30 years of experience 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 start-up 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 received his Regulatory Affairs Certification from RAPS, his Manager of Quality and Organizational Excellence certification from ASQ, and his Lean Black Belt from IIE.

Our Participants Testimonial


The presentation by Carolyn Troiana today was fantastic, both I and the QA Manager (Aaron Neighbour) loved it and had extensive conversation afterward about it. ( FDA Compliance and Mobile Applications Webinar )

Robert Friedland ( IT Manager) NUTEK BRAVO, LLC.

Thank you for providing the information in such detail. It was helpful to gain the perspective of somebody that has implemented these regulations in a working lab. Virtual Seminar on ( Training on Life cycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines )

Tracey Kessler ( Director of R&D) CEL-SCI Corporation

I felt the seminar was very helpful and provided good insight for DataIntegrity and what the FDA is looking for per the regulations. ( Current Regulatory Thinking on Data Integrity 2 Days Virtual Seminar )

Margaret A. Clifton ( Manager, Quality Systems) CSL Plasma

The presenters subject matter knowledge is extensive which enables information to be shared in detail. (Training Attended on Risk Based Verification and Validation Planning to Meed US FDA and ISO 13485 Requirements )

Stuart Chisholm (Sr. Principal Device Engineer) Teva Pharmaceuticals


About World Compliance Seminars (WCS)

World Compliance Seminars (WCS) is one stop solution for all your pharmaceuticalbiotechnology and medical device certification program needs. The pharmaceutical and medical device training requirements are set forth by the FDA (Food and Drug Administration) and other major regulatory bodies like NIHEMA, as well as numerous European based national regulatory bodies.

These requirements are important to the training of pharmaceutical reps who are responsible for the education, professional development, and on-the-job training. The training is broken down into different sections to cover a wide variety of topics, including pharmaceutical formulation, pharmaceutical transfer processes , GLP, GMP, Clinical ComplianceProcess Validation, Global Regulatory Affairs, Document Management,GMP (Good manufacturing practice) QSR and CMC and many more.

The pharmaceutical and medical device requirements that the FDA has set forth are designed to protect the public's health and safety. Pharmaceutical reps must adhere to all of the regulations and education courses provided by the FDA in order to be considered one of the best in their field. They also must complete ongoing educational opportunities and maintenance programs in order to maintain relevance and career enhancement.

Learn More