1000+ Sessions conducted on USFDA,EMA and APAC

How To Respond To FDA 483s

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Friday, 23rd February, 2018 01:00 PM GMT 08:00 AM EST

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

Equipment Validation, Tracking, Calibration and Preventive Maintenance

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Friday, 2nd March, 2018 01:00 PM EST 10:00 AM PST

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. However, there are ways to validate equipment already in use!

This webinar will discuss Equipment Calibration Requirements, Preventive Maintenance Requirements, when to use Calibration when to use Maintenance, what is Remedial Action for Out-of-Calibration Equipment, how to use of Calibration Standards to Save Cost.

Areas Covered in the Webinar:

  • Equipment Validation: Installation Qualification, Operation Qualification, and Performance Qualification..
  • Equipment Preventive Maintenance Requirements.
  • Calibration vs. Maintenance: When to use Which One?
  • Remedial Action for Out-of-Calibration Equipment.
  • Use of Calibration Standards to Save Cost.
  • Equipment Calibration Requirements: Scheduling, Use of External Services, and Documentation.

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

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

FDA Medical Device Regulation – Design Controls
FDA Medical Device Regulation – Design Controls
Sheila J. Ramerman, RAC

Founder

International Seminar on Corrective And Preventive Action In FDA Regulated Industry

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2018-04-06 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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