The field of GCP has rapidly evolved over the last 5 years and the requirements are getting tougher. Many companies find themselves unprepared for an FDA or EMEA inspection either at a clinical site or their headquarters. To prevent the surprises, early preparation is essential. Define expectations, train your staff and hold them accountable and the inspection will be easy to manage. This webinar will describe proactive measures you can take to assure that all systems are in place, operating well and operating in compliance.
Discussion on FDA’s new focus during inspection of computer systems and e-records, reasons for deviations and how to write CAPA plans to avoid 483 and respond to 483’s to avoid warning letters.
Why Should You Attend:
This Effective investigation Webinar/training will discuss how to align your investigation processes with ICH Q8-Q9-Q10 and reduce risk.
Areas Covered in the seminar:
* Common cognitive errors and how they result in reduced quality of investigations or erroneous conclusions.
* Risks posed by inadequate or ineffective investigations.
* Patterns that can be related to how humans process information.
* A process that utilizes the strengths, and minimizes the limitations, of human reasoning and behavior.
This Excel sheet validation training/Webinar will teach the step-by-step instructions for configuring Excel and validating your application.
Areas Covered in the seminar:
* Step-by-step instructions for configuring Excel and validating your application:
o Develop spreadsheet applications that are GxP compliant.
o Avoid 483s and warning letters.
o Apply features required for GxP environments without programming macros.
o Validate your application with minimal documentation.
This Standard Operating Procedures (SOPs) webinar training will give basic understanding of SOPs, and how to write and maintain SOPs for areas requiring SOPs as per ICH and new Medical Device Directive 2007/47/EC.
Areas Covered in the seminar:
* What is an SOP?
* Why do we need SOPs?
* What are the risks involved if we do not have and/or do not follow our SOPs?
* Some examples from warning letters about the need for SOPs.
* How do I write an SOP?
* What is a template for SOP development?
This Standard Operating Procedures (SOPs) webinar training will give basic understanding of SOPs, and how to write and maintain SOPs for areas requiring SOPs as per ICH and new Medical Device Directive 2007/47/EC.
Areas Covered in the seminar:
* What is an SOP?
* Why do we need SOPs?
* What are the risks involved if we do not have and/or do not follow our SOPs?
* Some examples from warning letters about the need for SOPs.
* How do I write an SOP?
* What is a template for SOP development?
This FDA software validation Webinar/training will discuss how to self audit and ensure validation and software quality processes that will pass FDA inspection.
Areas Covered in the seminar:
* Outline of FDA regulations as applied to software.
* Review of FDA software validation requirements.
* FDA inspection process.
* How to 'design to succeed'.
* Inspection preparation.
* Documentation review.
* Internal behavior review.
This CAPA and Risk Management Webinar/training will discuss the multi-level CAPA process and how regulatory standards requirement for CAPA relates to risk management.
Areas Covered in the seminar:
* CAPA requirements in 21 CFR 820 and ISO 13485 and how they relate to risk management.
* How to establish a multi-level CAPA process that meets requirements.
* Using risk management to assign CAPA resources and priorities.
* Updating risk management files with information from CAPA process.
* Risk Management and CAPA effectiveness checks.
This GMP inspection Webinar training will discuss how to prepare for an unannounced FDA GMP inspection and more over how to predict when they occur and how you should be ready to face it.
Areas Covered in the seminar:
* Can you prepare for an unannounced inspection? - yes.
* When do you begin the preparation.
* What to expect from the inspection.
* What are the hot topics to focus on.
* How to determine your weak points.
* How to best train people for a routine GMP inspection.
* Putting a strong repsonse to the observations in place.
The Medical Device Classification webinar explains the classification system in the US, the EU, following the Medial Device Directive (MDD), and the Canadian Medical Device Regulations (CMDR), and the guidance from the Global Harmonization Task Force (GHTF). This is a risk based approach implemented by regulatory authorities.
Areas Covered in the seminar:
* The Concepts Of Medical Device Risk
o Factors that may impact risk
o Regulatory controls keyed to risk
* Classification in the US
o Device Class
o Device Panel
