Webinar Recording: cGMP Compliance Series: How to Conduct & Manage a FDA Inspection

Presented: July 30, 2009

$100.00
$50.00
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Published: Wednesday, May 20, 2015

This webinar provides an overview of several significant developments related to California's Proposition 65. Companies that sell products in California should understand these recent changes and be prepared for additional changes that are in development.

 

Topics

  • The proposed listing of Aloe vera whole-leaf extract and goldenseal root powder as chemicals "known to the state to cause cancer" under the automatic Labor Code listing procedure
  • California’s Office of Environmental Health Hazard Assessment (OEHHA) proposal to amend regulations for providing “clear and reasonable warnings” for exposures to Prop 65 listed chemicals
  • AHPA's advocacy efforts and partnership with a coalition headed by the California Chamber of Commerce (CalChamber) to amend OEHHA's Prop 65 warning proposal
  • CalChamber's economic analysis to challenge OEHHA’s “false and unsupported” assertion that its proposed amended regulation will not have a significant adverse economic impact on businesses
  • Pulegone added to the Proposition 65 list of carcinogens, but naturally occurring pulegone is exempt
  • The pending lawsuit against OEHHA that challenges the current maximum allowable daily level (MADL) of 0.5 mcg for lead exposures and AHPA's advocacy efforts in regarding this lawsuit
  • The unsuccessful lawsuit against Beech-Nut which successfully argued that daily exposure to a Prop 65-listed chemical in a food could be determined by averaging consumption over 14 days. 
  • Legislation introduced to clarify when a person does NOT knowingly and intentionally expose an individual to a Prop 65-listed chemical and AHPA's support of this bill
  • 60-day notices sent to California medicinal marijuana dispensaries regarding a failure to provide warnings for exposure to marijuana smoke and AHPA resources for companies that may be impacted by these actions

Presenters

Trent Norris -- Senior partner in Arnold & Porter’s San Francisco office

Gary Roberts -- Member of Dentons' Litigation and Dispute Resolution and Environmental and Natural Resources practices

Anthony Samson -- Policy advocate for products regulation, environmental regulation, housing and land use policy at the California Chamber of Commerce

Mario Fernandez -- Staff counsel III in the Office of Environmental Health Hazard Assessment (OEHHA)

Cost 

Members: $220 

Non-Members: $520

The Botanical Safety Handbook, Second Edition includes:

  • Easily understood classification systems to indicate the safety of each listed species and the potential for drug interactions
  • Information on adverse events reported in clinical trials or case reports 
  • Safety-related pharmacology and pharmacokinetics of each herb
  • Additional information on the use of herbs by pregnant or lactating women 
  • Toxicological studies and data on toxic compounds 
  • Extensive references for each entry

The book is available in hardback print and online formats. Both versions contain the same information, but the online version, which is optimized for smartphones and tablets, has several additional attributes. Some of these relate to its operation, as it allows subscribers to search for keywords and botanical names and easily access the information they use most by saving personalized lists of entries. Perhaps more importantly, the online version will be updated regularly with new research, and subscribers will be notified of updates to provide immediate access to the most current information. The standard retail cost for either version is $119.95 (one-time cost in print; a renewable annual subscription online). We are discounting the cost for our members and would be happy to offer a discount to other organizations. A free preview of several entries are available online:

Subscribe to the online version or purchase a hardcover copy today. AHPA's Botanical Safety Handbook, Second Edition  Print Version: 1,042 pages, revised edition published in 2013 AHPA's Botanical Safety Handbook, Second Edition Online

Member annual subscription: $95.00 
Non-member annual subscription: $119.00 Discounts available for multiple user subscriptions.

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