1000+ Sessions conducted on USFDA,EMA and APAC

The Current State of Pharmaceutical CGMP and Data Integrity in Indian Pharmaceuticals

Register Now

Thursday, 29th June, 2017 04:00 PM IST 11:30 AM BST

This Webinar will help your firm to remain in good compliance with the US FDA. Discussion will include methods for maintaining a continuous quality improvement program thereby keeping your site ready for regulatory inspections all of the time.

Potential Negative Consequences of not Complying with CGMP Regulations

If you receive a Warning Letter or you firm is placed on the Import Alert List: you may have to stop manufacturing, recall your products, train all of your employees, validate your manufacturing processes, validate your testing methods and re-qualify your equipment. You will also be required to hire consultants.

This will cost you millions of dollars and could take several years to re-start your production. You will not obtain any new NDA or ANDA approvals and you will not be able to submit any changes to your already approved applications. Your stock price will go down. You may lose your customers and you may have to close your facilities.

This presentation will also include a summary of recent Warning Letters and Import Alerts issues to Indian Pharma. Key Areas Covered During the Webinar:

  • You will learn these good compliance practices from a former FDA Investigator and CDER Compliance Officer
  • This Webinar will help your firm to remain in good compliance with the US FDA
  • Details on the current state of Indian Pharma will be discussed
  • 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
  • You will learn the potential negative consequences of not complying with CGMP regulations
  • This presentation will also include a summary of recent Warning Letters and Import Alerts issues to Indian Pharma
  • Learning from competitors mistakes will prevent you from making these same mistakes

Equipment Validation, Tracking, Calibration and Preventive Maintenance

Register Now

Friday, 30th June, 2017 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.

FDA Internal Audits - An Important Tool for Avoiding Warning Letters

Register Now

Friday, 30th June, 2017 04:00 PM IST 11:30 AM BST

Internal audit is an examination of all or part of quality system with specific aim of improving it, usually conducted by the team appointed by the Management. It is an important tool for quality risk management. Internal audits can be a wake up call for the management and can avoid observations by regulatory bodies provided the audit is been conducted and enforced thoroughly. The speech covers various tools for successful Internal audit. The Audit should be thoroughly framed in PRE AUDIT- AUDIT-POST AUDIT structure. Successful Internal audit is important for creation of quality centered environment among different stakeholders of Management.

The presentation will discuss:

  • Planning of Pre Audit.
  • Focus areas during Audits.
  • Do's and Don'ts for Good Auditors.
  • Post Audit Considerations.

FDA Requirements for Good Clinical Practice’s and efficient and effective clinical trial

Register Now

Friday, 7th July, 2017 04:00 PM IST 11:30 AM BST

This Webinar will discuss the basics of Good Clinical Practice, but go even more to address the requirements to run an efficient and effective clinical trial. Few companies can afford to have a clinical trial start and then face compliance issues, or even more seriously run an inefficient trial, and fail to achieve clinical endpoints, not because of a lack of efficacy, but because the data was confounded by poor management of the trial.

This “more” discussion will go beyond Part 812 or Part 312, but will also include a discussion of ICH E-6 Good Clinical Practice: Consolidated Guidance (FDA's official guidance related to GCP).

We will also discuss the management process for designing clinical trials, selecting investigators, developing a clinical study implementation plan, and effective monitoring.

The presentation will discuss:

  • Common problems in GCP compliance
  • Planning a study to avoid non compliance
  • Establishing a clinical plan to launch, conduct, and finish a trial
  • Overall management of the trial
  • The role of audits of the clinical program
  • What to do when you discover non-compliance with GCP

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

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

No live seminars available
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 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

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

Quality and Regulatory Affairs

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.

//