8GB iPhone to cost Rs 31,000?

August 12, 2008

The wait finally seems to be over. According to reports, the pricing of the most-awaited gadget Apple iPhone, set to be launched in India on August 22, is out.

Reports indicate that the 8 GB version of the 3G iPhone will cost Rs 31,000, while the 16 GB version will cost between Rs 36,000–37,000.

The above pricing is exclusive of the rental plan the phone will come bundled with.

Last week Bharti Airtel and Vodafone announced that they will launch iPhone on August 22.

In a statement, Bharti said that millions of Airtel subscribers will be able to purchase the iPhone at Airtel’s Relationship Centres from August 22.

“iPhone has been an iconic technological revelation of this year and Airtel has been at the forefront of innovation and customer delight in the Indian telecom sector,” Sanjay Kapoor, President, Bharti Airtel mobile services, said.

iPhone is embedded with all 3G features and is twice as fast as the existing mobile phones. The phone also has in-built GPS system, which facilitates as navigation and positioning tool.

Source: TimesofIndia

Upcoming Pharmaceutical webinars

August 12, 2008

Here are the good number of Pharmaceutical related webinars:

  1. Technology Transfer of a Pharmaceutical Manufacturing Process
  2. Organization of Clinical Datasets in eCTD Submissions
  3. Designing an Effective Cleaning and Disinfection Program for Pharmaceutical, Biotech, and Medical Device Cleanrooms
  4. Ensuring Good Clinical Practice
  5. Pharma Sales Force Effectiveness: Increasing Productivity Through Streamlined Internal Communication
  6. Integrating Quality into Business Systems for High Performance
  7. Principles of Sterile Manufacturing
  8. Getting the Most Out Of Data Mining for Pharmacovigilance and Risk Management
  9. Transforming Pharmaceutical Sales and Marketing through Offshore Business Intelligence (BI) Services
  10. High Performance in Pharmaceutical R&D
  11. Using Electronic Health Records and Claims Databases for Rapid-Response Pharmacovigilance Studies
  12. Online Training for Laboratory Compliance- Pack of two courses

Upcoming Medical Device webinars

August 12, 2008

I found a website where good number of webinars are available across Medical Device, Pharma, HR, Healthcare, right now I am listing medical device related webinars here but for further areas please refer ComplianceOnline.

  1. Process Mapping – Risk-Based P&PC
  2. Bullet-Proof CAPA
  3. Management Controls Under QSR and ISO 13485
  4. Introduction to Process Capability (Cp, CpK, Pp, Ppk)
  5. Successful 510(k) Submissions
  6. Designing an Effective Cleaning and Disinfection Program for Pharmaceutical, Biotech, and Medical Device Cleanrooms
  7. The Gateway: A Risk-Based Filter for Effective CAPA Management
  8. Design and Process FMEA Concepts
  9. Using HACCP Quality Plans to Improve Medical Device Compliance Outcomes
  10. Basic Requirements for Steam Sterilizer Validation per ISO 17665
  11. The Rapidly Emerging Field of FDA Safety Science:Its Impact on Regulatory Affairs, Quality Systems and Company Profitability
  12. Internal Auditor Training for ISO 13485 Auditors
  13. Understanding ISO 13485 vs. ISO 9001 for Successful QMS in Medical Device Industries
  14. Preparing for a U.S. FDA Audit
  15. Regulatory Requirements for Personnel Training to Assure QSR and ISO Compliance
  16. Managing Risk at the R&D–Manufacturing Interface
  17. The Road to FDA Approval: Advisory Committee Survival Strategies

Advice on medical device labeling

August 12, 2008

Medical Design & Manufacturing East conference session, Food and Drug Administration regulatory policy analyst Arthur Yellin offered the following advice on medical device labeling:

• The Food, Drug and Cosmetic Act defines a label as information on the immediate container and does not include package liners. Labeling refers to all labels and “other written, printed, or graphic matter” on or “accompanying” a regulated product.

• Labeling must be truthful and complete. It may not be misleading in any respect. All required information must be clearly readable and understandable.

• Although the FDA does not define a minimum type size, generally 6-pt type is the smallest acceptable for required information.

• Prohibited from use on medical device labeling are references to 510(k) clearance, false or misleading statements, undefinable superlatives such as superior, best, or strongest, and the term “hypoallergenic” for latex-containing devices.

• If only a distributor is named, it must be identified as “manufactured for” or “distributed by” or similar wording.

• Devices manufactured with components from multiple countries need to be labeled with the predominant source country. Yellin noted this is required by the U.S. Customs Service, not the FDA.

• Directions for use of over-the-counter devices should be such that a layperson could use the device safely for its intended purpose. Prescription devices, for which directions for laypersons cannot be written, must be labeled with indications for use, effects, routes, methods, frequency and duration of use, hazards, contraindications and precautions, as well as known side effects.

• A tricky one: If the labeling contains any representation in a foreign language, then all required words, statements, and other information must also appear on the labeling in that foreign language.

• In vitro diagnostic devices must be labeled as required by 21 CFR 809.10 andinclude proprietary and established names; intended use; the established name and quantity if it’s a reagent; and storage instructions for the reagent; the expiration date; information about deterioration; the name and address of the manufacturer, packer, or distributor; and the lot or control number.

Source:  Healthcare packaging

You can also refer complianceOnline for labeling and medical device related webinars

Marketing lessons from FDA warnings

August 12, 2008

The FDA’s marketing regulators have either been pulling their punches lately or drugmakers are complying with promo rules better than usual, because the number of warning letters about advertising and brochures and mailers last quarter could be counted on one hand–and so far this quarter, there hasn’t even been one. As Eye on FDA notes, the letters can be mini-lessons in compliance, so here’s the summary of the second quarter action:

  • Pfizer was cited for a sildenafil citrate video that didn’t include any risk information. The video referred viewers to that info on a web page, but the FDA didn’t see that info. Lesson? Even online videos should include risk info, just like TV commercials.
  • Zila Pharmaceuticals got tagged for a professional mailer about its oral rinse Peridex. The mailing included the rinse’s package insert. But because that insert wasn’t physically attached to the promotional brochure, it didn’t count. Lesson? No detachable risk info.
  • Novartis was cited for a Trileptal magnet because the risk info was on the back, where it couldn’t be seen. Lesson? Risk info in view at all times.
  • Shire got its hand slapped for a reminder ad that wasn’t. A reminder ad, as you know, is supposed to just include the drug name–no indications, dosage, or other info. FDA said the Shire ad looked like a reminder ad, but contained language about indications. Lesson? Calling an ad a reminder ad doesn’t make it one.

Source: Eye On FDA