1000+ Sessions conducted on USFDA,EMA and APAC

Complaint Handling in Compliance with FDA and ISO Regulations

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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

Pitfalls in the Analytical Characterization of Biosimilar Biological Products

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

Due to the complexity of biological products, extensive analytical characterization is required by regulatory agencies to demonstrate biosimilarity. To successfully develop a biosimilar, the sponsor will have to determine whether the biosimilar is highly similar to the reference product and that the product is safe and efficacious. When comparing the analytical properties of your biosimilar product to the reference product, you may find that analytical similarity is not always seen. During this webinar you will learn about how to prepare for and overcome such challenges
Key Areas Covered During the Webinar:

  • How to demonstrate biosimilarity
  • Analytical methods and the factors affecting the analytical characterization
  • What to do when analytical similarity is not observed.
  • Immunogenicity risk assessment
  • FDA’s opinion on inadequacies in IND or BLA

Implementation of Pharmaceutical Quality system ICH Q10

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Friday, 17th November, 2017 01:00 PM EST 10:30 AM PST

ICH Q10 Describes harmonized Pharmaceutical Quality system model which is at implementation stage by three regulatory bodies to ICH i.e. from united states, Europe and Japan.This Quality system model can be applied effectively by organization at all product life cycle stages i.e. during product development, technology transfer, commercial manufacturing and product discontinuation. Elements of Pharmaceutical quality systems can be systematically utilized to enhance process performance and product quality. This is by achieving ICH objectives i.e. achieving product realization, maintaining state of control and continual improvement. Quality risk management and effective utilization of knowledge at all stages of product helps in achieving these objectives and hence enable organization to implement ICH Q10 effectively.
Key Areas Covered During the Webinar:

  • Brief on Pharmaceutical Quality system ICH Q10 & its need.
  • Understanding of Scope and objectives of ICH Q10
  • How ICH Q10 can be implemented effectively.
  • How to design Pharmaceutical Quality system.
  • Importance of management role & responsibilities.
  • How to manage process performance and product quality in your organization.
  • How to keep continual improvements in Pharmaceutical Quality system.

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

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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

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