Powered Industrial Trucks: California’s Requirements for Equipment, Workplace Postings, Safe Operation, and Training

June 26, 2008

According to federal OSHA’s most recent statistics, more than 90,000 workers each year are injured, and 100 workers die, in forklift accidents. Workers are killed when a forklift tips over, when a forklift collides with pedestrians, when the worker is crushed by a forklift, or when the worker falls from a forklift.

This Special Report will help you navigate Cal/OSHA’s sometimes—confusing industrial truck standards, which are arranged differently than federal OSHA’s regulation and have different specific requirements. This Report will also help you ensure that your equipment meets Cal/OSHA standards by providing a comprehensive checklist you can use to inspect your equipment. Safe operating rules—which must be posted in the workplace—and training and instruction requirements are all thoroughly explained.

Download the entire report (PDF)

You can check ComplianceOnline for more OSHA related webinars from experts


How to Dispose of Unused Medicines

June 24, 2008

Is your medicine cabinet filled with expired drugs or medications you no longer use? How should you dispose of them?

Most drugs can be thrown in the household trash, but consumers should take certain precautions before tossing them out, according to the Food and Drug Administration (FDA).

Guidelines for Drug Disposal

  • FDA worked with the White House Office of National Drug Control Policy (ONDCP) to develop the first consumer guidance for proper disposal of prescription drugs. Issued by ONDCP in February 2007, the federal guidelines are summarized here:
  • Follow any specific disposal instructions on the drug label or patient information that accompanies the medication. Do not flush prescription drugs down the toilet unless this information specifically instructs you to do so.
  • If no instructions are given, throw the drugs in the household trash, but first:
    • Take them out of their original containers and mix them with an undesirable substance, such as used coffee grounds or kitty litter. The medication will be less appealing to children and pets, and unrecognizable to people who may intentionally go through your trash.
    • Put them in a sealable bag, empty can, or other container to prevent the medication from leaking or breaking out of a garbage bag.
  • Take advantage of community drug take-back programs that allow the public to bring unused drugs to a central location for proper disposal. Call your city or county government’s household trash and recycling service (see blue pages in phone book) to see if a take-back program is available in your community.

Source: FDA

Even you can learn more about various FDA related rules and regulations at ComplianceOnline


Regulatory Bodies Across Globe

June 18, 2008

UNITED STATES OF AMERICA

The US Food & Drug Administration
Home Page
Current Guidances
Dockets Management Homepage
Electronic Freedom of Information
Investigations Operations Manual 2006
Medical Device GMP Reference Information
Modernization Act of 1997 (FDAMA)
References for the Regulatory Process for the Office of Cellular, Tissue and Gene Therapies (OCTGT)

CANADA
Health Canada Drugs and Health Products
Home Page
Biologics and Genetic Therapies
Biologics and Genetic Therapies Fact Sheet


EUROPE

European Medicines Agency
Homepage
Gene Therapy Expert Working Group

European Commision
Proposal for a Harmonised Regulatory Framework on Human Tissue Engineered Products: DG Enterprise Consultation Paper


UNITED KINGDOM

National Institute for Biological Standards & Control:
Homepage

Medicines and Healthcare Products Regulatory Agency:
Homepage


ASIA & THE PACIFIC

AUSTRALIA

Australian Therapeutic Goods Administration
Australian Research Council
Australian Stem Cell Centre
Biotechnology Australia

INDONESIA
Indonesian Ministry of Health

JAPAN
Japan’s Pharmaceuticals and Medical Devices Evaluation Center

KOREA
Korean Food and Drug Administration

NEW ZEALAND
MedSafe
New Zealand Bioethics Council

PEOPLE’S REPUBLIC OF CHINA
National Institute for the Control of Pharmaceutical & Biological Products (in Chinese)
State Food and Drug Administration (in Chinese)
Ministry of Health (in Chinese)

SINGAPORE
Singapore’s Health Sciences Authority
Singapore Bioethics Advisory Committee Homepage

TAIWAN
Bureau of Food and Drug Analysis

INDIA
Central Drug Standard Control Organization:


INTERNATIONAL

World Health Organization
Quality Assurance and Safety of Medicines

International Society for Cellular Therapy

International Society for Cellular Therapy: Regulatory Affairs Europe
International Society for Cellular Therapy: Regulatory Affairs North America

International Society for Life Sciences Professionals
International Regulatory Information

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
Topics and Guidelines

Regulatory Affairs Professionals Society
Home Page
Combination Products Resource Page

The 21CFRPart11.com
Provides access to information on the rules and also maintains an email list that actively discusses issues and concerns with industry peers and government regulators.
Homepage

Source: Cell Therapy News


FDA Regulations Relating to Good Clinical Practice and Clinical Trials

June 17, 2008

FDA has set up website with links to all FDA regulations related to Good Clinical Practices and Clinical Trials. The site has also a link to preambles to GCP regulations with valuable information about the development of final rules for Good Clinical Practices and clinical trials.

Source:FDA