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This webinar will discuss current regulatory and quality requirements for reduced testing of components used in pharmaceuticals and medical devices. Reduced testing will be viewed from current industry practice, the regulations,

"Attendees will recieve a complimentary e-book of " How to write standard operating procedures and work Instructions", published by the Instructor in 2010.The e-book will be send out to attendees after the webinar.

This DMFs (Drug Master Files) training will discuss the current review and enforcement climate within FDA and the manner in which drug master files (DMFs) are reviewed by FDA personnel.

This Medical Device training will be discussing the newly-updated requirements of the Medical Device Directives,

Holders of the IND for new products i.e. the Sponsors. Also, Principal Investigators and sub investigators, Clinical Research Scientists Safety Nurses, Clinical Research Associates and Coordinators , Recruiting staff, QA / QC auditors and staff.

This webinar will present a methodology for system assessment, risk-analysis, 21CFR Part 11 compliance, remediation and inventory, along with templates and forms that attendees can modify for their own business.

Nearly every computerized system used in laboratory, clinical, manufacturing settings and in the quality process has to be validated. Finding efficiencies without weakening the quality position is essential.

This 21 CFR Part 11 webinar/training will discuss on the technical details required by technical personnel to understand, communicate and implement part 11 compliance in to computer systems regulated by FDA.

This webinar on safety reporting in clinical trials will focus on the major revisions that FDA made to its IND safety reporting requirements.

This vendor qualification training will provide valuable assistance on how to avoid costly regulatory action from agencies when they inspect your facilities in pharmaceutical and biotech industries .

The FDA has ramped up surveillance and we have seen an increase in the number of warning letters issued to manufacturers.

Understand the steps of a extractables / leachables study, get knowledge about the gap analysis of literature sources and how to design an efficient E/L study.

This 4hr seminar on Outsourcing for Pharmaceuticals and Biologics will provide a practical guide to the ‘processes’ of strategic outsourcing and the subsequent effective management of the outsourced relationship.

The webinar will explain how the pharmaceutical industry stakeholders can build and institutionalize risk management processes across the end-to-end supply

This training on adaptive designs for clinical trials will help you indentify situations in which adaptive designs would be advantageous and describe the operational and administrative changes to trials under various adaptive designs.

This webinar will clearly explain the regulatory requirements (FDA, USP, ICH, EMA) for Validation of Analytical Methods and Procedures and present practical approaches for implementation.

Learn computer system validation essentials and eight fundamental steps of implementation for cost saving. Get complementary SOPs and checklists for easy implementation. Understand the structure of validation plan.

How to Use excel spreadsheet for GXP data and reduce validation cost and time.

This FDA validation training will describe methods for planning and executing spreadsheet validations that satisfy FDA requirements.

Attend this webinar to understand the process of a letter of credit and how to comply with letter of credit requirements to help reduce or prevent costly discrepancies.

In this Food safety training learn about Food preservation, traditional heat treatment, emerging food processing technologies, sterilization, shelf stable products, low acid foods, US FDA and USDA regulations

This Deviation, Investigation and CAPA training will provide valuable assistance on how to avoid costly regulatory action from agencies when they inspect your facilities in pharmaceutical and biotech industries

This Clinical trial auditing training will provide valuable assistance how to conduct clinical trials both using internal resources and also those that outsource the function to CRO’s in pharmaceutical and biotech industries.

With a new emphasis on risk management, regulators expect you to have a robust system. Can your system stand up to scrutiny or will it wilt when exposed to bright light?

It will focus on important microbial issues with pharmaceutical water systems and provide proven solutions for microbial control. Attendees will learn effective sanitation and validation approaches to successfully control biofilm in water systems.

This webinar will help you understand the current quality and regulatory paradigm by comparing and analyzing ICH-Q10 Pharmaceutical Quality System and the FDA’s Quality Systems Approach (FQSA) to Pharmaceutical GMPs .

This training on FTC’s New Substantiation Standards will provide an comprehensive understanding of the new standards, when they will apply and how you can satisfy them.

This webinar on Retirement of Computer Systems will give a good understanding of FDA and equivalent international requirements and will provide recommendations and tools for effective implementation.

This webinar on Lyophilization Process Development and Cycle Design will cover the process and benefits of using an empirical approach to design an optimized lyophilization cycle.

This webinar will cover the basics on how to maintain a good Design History File that will help a manufacturer during a regulatory compliance audit

This Clinical trial auditing training will provide an understanding of how to conduct compliant and successful clinical trials by defining FDA clinical trial audit procedures, audit program, audit planning and audit preparation.