1000+ Sessions conducted on USFDA,EMA and APAC

FDA - Important Aspects to Consider When Determining Interchangeability

Register Now

Friday, 20th October, 2017 01:00 PM EST 10:30 AM PST

On January 17, 2017, FDA released the long-awaited draft Guidance for Industry to help firms understand the considerations FDA deems necessary to prove interchangeability between an approved reference product and a proposed, less-expensive biologic.

Obviously, it’s critical for industry to understand the points addressed in this new guidance:

  • What does FDA expect from manufacturers who feel they have a product which can be approved as interchangeable under the BPCI Act?
  • What are the differences between biosimilar and interchangeable biologics?
  • What studies are needed to demonstrate biosimilarity?

Key Areas Covered During the Webinar:
  • Understand key definitions
  • How to demonstrate interchangeability?
  • Why immunogenicity is important to consider for interchangeable products?
  • What are the factors affecting immunogenicity and how to mitigate the risks.
  • How to design studies required to demonstrate interchangeability?

Complaint Handling in Compliance with FDA and ISO Regulations

Register Now

Friday, 27th October, 2017 01:00 PM EST 10:00 AM PST

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 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 explained.

The presentation will cover the following areas:

  • FDA and ISO requirements for complaint handling
  • Establishment of complaint handling program
  • What constitutes a complaint
  • ISO-specific implications of complaint handling
  • The roles of investigation and corrective action in complaint handling
  • Complaint trending and reporting
  • Application of risk management to complaint handling program

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

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

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

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

Supplier Management in FDA-Regulated Industry

Register Now

2017-11-02 09:00 AM - 04:00 PM EST

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 significantly less time and money, and still be in control of their suppliers and in compliance with the regulations. This seminar 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. Also prominently covered will be supplier nonconformances: issuance, followup, and acceptance.

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 Corrective And Preventive Action In FDA Regulated Industry
International Seminar on Corrective And Preventive Action 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

FDA Inspections, Warning Letters, & CAPA 2015 Update
FDA Inspections, Warning Letters, & CAPA 2015 Update
J. Lawrence Stevens, RAC

FDA Regulatory Expert

Content Disclaimer

Contents in our website are from external websites. Links to and content from external website are provided for the convenience of users. Biopractice.com takes no responsibility for the content of such links and websites.

//