Risk Evaluation and Mitigation Strategies (REMS) what you need to know in order to comply with FDA’s new requirements

June 1, 2009

What you need to know in order to comply with FDA’s new requirements :Risk Evaluation and Mitigation Strategies (REMS)

FDA compliance training will be valuable who are involved in the development of REMS and who are planning a submission and need to understand what might be required by FDA and how to comply and for those who have Risk Management Plans.

Learn here –

  • What is a REMS(Risk evaluation and mitigation strategies)?
  • What products are currently required to have a REMS(Risk evaluation and mitigation strategies)?
  • Where to start when writing a REMS(Risk evaluation and mitigation strategies)?
  • What department need to be involved in the preparation of a REMS(Risk evaluation and mitigation strategies)?
  • Without a REMS(Risk evaluation and mitigation strategies) guidance document …What format is FDA currently requiiring,?

Source: ComplianceOnline

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Upcoming Pharma and biotech webinars/training

May 26, 2009

Check Pharma and Biotech webinars

Compliant GCP (Good Clinical Practice) Studies – Working with a CRO

Learn here

  • Steps to meet the sponsors requirements.
  • How to know – are GCPs being followed and is it documented.
  • Know the “relationships” – QA, Clinical and the CRO.
  • The Audit (aspects and specifics).
  • How to do an audit follow-up.
  • Post CRO Assessment – How

Objectionable Microorganisms: Considering the Risk

Learn here

  • What is an Objectionable Microbe?
  • Pathogens vs. Objectionables.
  • Just how objectionable is it?
  • Consider the risk.
  • Performing a risk assessment.

Advanced Topics in Good Documentation for GXPs

Learn here

  • The documentation practices that enhance study integrity, repeatability.
  • How to prevent 483 items related to data documentation.
  • The main documentation errors seen and cited by the FDA.
  • Why GLP serves as a good foundation for clinical studies, GMP, and even research.
  • Tips for documentation in lab notebooks.

Japanese PAL – JPAL Technical, cultural and language challenges when dealing with MAH, PMDA, Distributors and Customers

Learn here

  • Undertanding Japanese culture in context of JPAL.
  • Risk adversity in the MHLW, PMDA and filtering down to the MAH.
  • Language: Translations, interpretations and resulting gaps.
  • Technical differences – How to respond and persevere.
  • Culture differences – Sometimes we just have to go along.
  • Submission data – Best practices for common understanding.

Basics of testing associated with sterilization validation and routine processing

Learn here

  • What are the appropriate types of tests during sterilization validation.
  • What standards should be used for the testing.
  • What type of samples and sample sizes should be used.
  • What testing needs to be performed routinely.
  • What frequency of testing is recommended.
  • What methods can be used to reduce testing.

Source: ComplianceOnline


Water system compliance training/webinar

May 20, 2009

Check out upcoming list of Water system compliance training/webinar focuses on the factors that can lead to water system sanitization success as well as failure so that the user can not only devise workable sanitization approaches.

  1. Water System Compliance – Successful Sanitization Approaches for Trouble-Free Water Quality
  2. Water System Compliance – What Makes Water Systems Have Microbial Quality Problems
  3. Water System Compliance – Harmonizing Water Microbial Testing for Optimal Quality Control
  4. Water System Compliance – Understanding and Controlling Endotoxin
  5. Water System Compliance – Implementing Changes to a Validated System

Source: ComplianceOnline


Medical Device training / webinars

April 29, 2009

Check out for medical device trainings/webinars

1. Process Validation for Medical Device Manufacturers

This Process validation training will discuss the CDRH interpretation of the GHTF guidance and how manufacturers should develop Process Validation Plans and conduct production Process Validation.

2. Risk Analysis and Human Factors Engineering

The Risk analysis training will incorporates these techniques into the overall product lifecycle using the principles of ISO 14971 and how to develop an integrated program incorporating risk analysis and human factors engineering.

3. Basic Requirements for Steam Sterilizer Validation per ISO 17665

This Steam Sterilization training will review the general requirements for performing a steam sterilizer validation via the “overkill” half-cycle method as described in ISO 17665 (supersedes ISO 11134).

4. Japan – Regulatory Filing Requirements and Compliance Processes for Life Sciences PART II

This Regulatory compliance training is designed to provide an overview of the regulatory environment in Japan.

5. A Case Study in Equipment / Process Software Verification and Validation

This FDA compliance Training will guide through the models simplifies regulatory requirements for equipment software V&VT, assuring key FDA requirements are not overlooked. QMS and 21 CFR Part 11 require yet another approach.

6. Japanese PAL – JPAL QMS requirements in Ordinance 169 and differences to ISO 13485

This JPAL (Japanese Pharmaceutical Affairs Law) QMS will explore, in detail, the QMS requirements placed on the foreign manufacturer via Ministerial Ordinance 169, Ordinance 2 and Ordinance 179.

Source: ComplianceOnline


Is that right time to think over Corporate governance seriously by Indian Companies

January 8, 2009

Yes would be the answer of most the Corporate today by seeing what happened to Satyam. Most of the Indian corporate accept that loopholes must be plugged in regulation, audit and governance to restore the confidence of the stakeholders in corporate firms.

Increased focus on directors’ and executives’ role and responsibilities requires systematic frameworks for implementing critical corporate governance principles on ethics, code of conduct, compensation, financial policy, and financial reporting. Moreover, organizations are looking for sophisticated corporate governance solutions to enable them to set business priorities and develop risk management strategy to ensure business performance.

Here where the companies like MetricStream,ComplianceOnline,Approva,Certus Software,IBM,Sai global plays important role.

Attend Live | On- Demand Webinar from ComplianceOnline to know more on Corporate Governance

Source: MetricStream | ComplianceOnline


Contract Research Organisations (CRO) Market: US

December 2, 2008

The US CRO market is predicted to have a healthy future, with the greatest potential for growth in the preclinical sector, according to a report by Frost & Sullivan.

In areas such as toxicology studies outsourcing penetration is low, according to the report, which presents an opportunity for companies willing to invest in the sector.

The report says an increase in capital expenditure will be necessary to build or acquire the facilities needed to enter the preclinical toxicology market.

Despite this the report notes that several contract research organisations (CRO) have been making investments in their early stage capacity.

The report predicts that such investments will help the US CRO market grow from the $9.77bn it earned in 2008 to $23.78bn by 2015.

Biotechs are predicted to be the strongest driver of growth, followed by specialty pharmaceuticals and niche and startup small molecule companies.

Although the report predicts a bright future for the US CRO industry it also highlights necessary adaptations if companies are to prosper in an increasingly competitive and fragmented market.

It also forecasts that these factors will result in lower margins for contracts and consequently companies may find it difficult to translate a strong backlog into revenues.

In addition, the global nature of many CROs means that companies will need to work closer with IT vendors to ensure their systems are suitable for the changing market.

Consequently the report predicts that CROs will play an increasing role in choosing IT systems and platforms, with the power to make decisions shifting away from sponsors.

Source: Outsourcing Pharma

Click here- ComplianceOnline to attend live Webinar


What is a clinical trial?

August 19, 2008

For the purposes of registration, a clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Interventions include but are not restricted to drugs, cells and other biological products, surgical procedures, radiologic procedures, devices, behavioural treatments, process-of-care changes, preventive care, etc.

What is the difference between a clinical trials register and a clinical trials registry?

A clinical trials register is the formal record of an internationally agreed minimum amount of information about a clinical trial. This record is usually stored in and managed using a database.

A clinical trials registry is the entity that houses the register, and is responsible for ensuring the completeness and accuracy of the information it contains, and that the registered information is used to inform health care decision making. A clinical trials registry is more than its database.

Source: WHO

You can also refer complianceonline to see good webinar on clinical trials