1000+ Sessions conducted on USFDA,EMA and APAC

How FDA Evaluates Your Quality Management System

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Friday, 26th January, 2018 01:00 PM EST 10:30 AM PST

Once your company has successfully navigated the U.S. device clearance process, a Quality Management System (“QMS”) needs to be implemented before you can start marketing your product. Your QMS must contain all the requirements of FDA’s Quality System Regulations (“QSR”).

QSR imposes many requirements but contain little detail in how to implement them; however, failure to appropriately interpret these requirements could result in significant impact on your company, which may include temporary or permanent removal of your device from the market.

The presentation will cover the following areas:

  • Introduction to FDA Regulations
  • Overview of Quality System Regulations (“QSR”)
  • How FDA Evaluates Your Quality Management System (“QMS”)
  • Most Inclusive Requirement: Document Control
  • Most Critical FDA Non-conformances
  • Most Common FDA Non-conformances

How To Respond To FDA 483s

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Monday, 5th February, 2018 01:00 PM EST 10:30 AM PST

We are pleased to announce the premier edition of ‘Response to 483s’ Webinar. As you will agree, responding to 483s is one of the major challenges being faced by Quality Heads from pharmaceutical companies. With the USFDA keeping a close check on observations in a Pharma facility, it is imperative that we provide knowledge on best practices to respond effectively and sincerely to a 483 being issued by the USFDA.

Key Areas Covered During the Webinar:

  • Recovery options from an FDA 483
  • Devising a CAPA for your 483
  • Root Cause Identification to understand where the problem lies and linking it to QMS
  • Impact Assessment
  • Devising a strong CAPA
  • Effective checks on CAPA
  • Discussion will include methods for maintaining a continuous quality improvement program
  • Provide methods for avoiding FDA-483 observations
  • Good Practices on how to verbally respond to FDA-483 observations during the exit meeting

Understanding Bioavailability And Bioequivalence Studies Required for INDs, NDAs and Post-Approval Filings

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Friday, 16th February, 2018 01:00 PM EST 11:30 AM BST

Bioavailability (BA) and Bioequivalence(BE) Studies submitted for INDs, NDAs and post-approval filings will be discussed during this webinar. BE studies are primarily associated with establishing that a generic product filed in an ANDA is the “same” as the innovator product. However, BE studies, though done for a different purpose, are very often necessary to support INDs, NDAs, and post-approval filings. Information generated from such studies influence the overall clinical development plan and product labeling.
Areas Covered in the Webinar:

  • All relevant regulatory requirements for establishing the necessary BA and/or BE studies for INDs, NDAs and supplements to NDAs.
  • Differences between BE studies for ANDAs and studies required for INDs, NDAs and post-approval filings.
  • Determine the overall clinical development plan and labeling of the product.
  • Types of BA and BE studies, including for INDs, as well as pivotal BE studies required to bridge the to-be-marketed formulation

Executive insights into the FDA "Purple Book" Classification and other FDA initiatives reg...
Executive insights into the FDA
Dr. Hoss A Dowlat, RA

VP, Global
Strategy

Equipment Validation, Tracking, Calibration and Preventive Maintenance
Equipment Validation, Tracking, Calibration and Preventive Maintenance
Jeff Kasoff, RAC, CQM/OE

Quality and Regulatory Affairs

How FDA Trains Its Investigators to Review CAPA, and What You Can do to Prepare
How FDA Trains Its Investigators to Review CAPA, and What You Can do to Prepare
Jeff Kasoff, RAC, CQM/OE

Quality and Regulatory Affairs

Complaint Handling in Compliance with FDA and ISO Regulations
Complaint Handling in Compliance with FDA and ISO Regulations
Jeff Kasoff, RAC, CQM/OE

Quality and Regulatory Affairs

The clinical, regulatory and business challenges and rewards of Orphan Med development and...
The clinical, regulatory and business challenges and rewards of Orphan Med development and...
Dr. Hoss A Dowlat, RA

VP, Global
Strategy

FDA Medical Device Regulation - Unique Device Identifier Requirements
FDA Medical Device Regulation - Unique Device Identifier Requirements
Sheila J. Ramerman, RAC

Founder

International Seminar on Corrective And Preventive Action In FDA Regulated Industry

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2018-02-09 09:00 AM - 01:00 PM EST

The objective of this course is to provide the tools you need to develop and implement a compliant and effective CAPA system, from clear understanding of regulatory requirements to accurate root cause determination to confirmation of CAPA effectiveness.

The session will focus on uderstanding CAPA and will discuss about the Elements of a Corrective Action Program

Jeff Kasoff, RAC, CQM/OE, 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 received his Regulatory Affairs Certification from RAPS in 1996, his Manager of Quality and Organizational Excellence certification from ASQ in 2013, and his Lean Black Belt from IIE in 2014.

International Seminar on Complaint and Adverse Event Management
International Seminar on Complaint and Adverse Event Management
Jeff Kasoff, RAC, CQM/OE

Quality and Regulatory Affairs

Supplier Management in FDA-Regulated Industry
Supplier Management in FDA-Regulated Industry
Jeff Kasoff, RAC, CQM/OE

Quality and Regulatory Affairs

International Seminar on How To Respond To FDA 483s
International Seminar on How To Respond To FDA 483s
Brian G. Nadel

President

International Seminar on FDA Inspections in the 21st Century
International Seminar on FDA Inspections in the 21st Century
J. Lawrence Stevens, RAC

FDA Regulatory Expert

International Seminar on How FDA Trains Its Investigators to Review CAPA
International Seminar on How FDA Trains Its Investigators to Review CAPA
Jeff Kasoff, RAC, CQM/OE

Quality and Regulatory Affairs

International Seminar on Protecting Patient Information - It's the Law
International Seminar on Protecting Patient Information - It's the Law
J. Lawrence Stevens, RAC

FDA Regulatory Expert

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