Labcompliance On-line Audio Seminar

This seminar has been recorded and is available on CD and for instant download. All reference material as listed below and more is available on a special seminar website. The website is regularly updated with most recent information. In case there are questions related to the topic, they can be submitted through a web form and will be answered by the speaker. For ordering info click here.

On-line Audio Seminar 203

FDA Globalization Act: More Fees, More Inspections

Understanding the impact on domestic and international companies

Recorded

The act as proposed on April 17, 2008 and officially introducerd as bill in Jan 2008 should significantly increase FDA's resources and power for overseeing drug, API, device, cosmetics and food suppliers. Recommendations include a registration fee for domestic and foreign manufacturers to fund inspections, initial and regular inspections of all facilities, establishment of dedicated foreign inspectorates, import of drugs through areas with FDA testing laboratories or documented product testing through accredited laboratories, and identification and better documentation of origins of APIs. The bill just documents several FDA initiatives to ensure better quality of healthcare products. However, there are many questions.

Key questions related to the FDA Globalization Act  are :

• How does the Act impact US companies?
• What is the impact on pharma and device companies?
• How much is the registration fee, is it one time or annually?
• FDA plans to increase inspections: Are we at risk to get inspected?
• How frequently will API manufacturers be inspected?
• I have heard that there can be very high civil penalties. Who has to pay and under what circumstances?
• What is the process to get testing laboratories acredited?
• How are other industries affected: food, cosmetics?
• When will it be effective?
• Should we react now or can we wait?
• What about Europe. Are there similar initiatives?

How does the this audio seminar help:

Answers will be presented by Dr. Ludwig Huber in a new interactive audio seminar. During the seminar, the speaker will present strategies and give practical recommendations. After the seminar, an extensive list of reference material like SOPs, templates and examples will help immediate and cost effective implementation.

During the interactive presentation you learn about:

• Reasons for the initiative: current issues
• History, current status and future plans for domestic and foreign FDA inspections
• The new act: history, status, future plans (timing)
• Going through the detailed contents
• Impact on domestic and foreign device and pharma companies
• Impact on API manufacturers and other suppliers
• Impact on other industries: food, cosmetics
•  Criteria for FDA inspections: Risk based approach
• Current FDA inspection trends and examples for frequently found deviations
• Feedback from industry organization and FDA's response
• Other FDA initiatives for import safety
• Comparison with European agencies
• Recommendations for implementation

And for easy and instant implementation:
download 10+ documents from special seminar website

• FDA Globalization Act of 2009
• Example SOPs:
  - FDA Inspections:
  - International inspections
  - Supplier audits
• Gap analysis/checklist:
  - Good Manufacturing Practices
  - Laboratory accreditation (if testing needs to done by accredited laboratories)
  
• Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 3: Regulatory Audit Report (link)
• Recommended activity list for the next 12 months
• Discussion on outsourcing with industry and officials
• Statement of Janet Woodcock, M.D.,Director, CDER,
  Discussion Draft Of The ‘Food And Drug Administration Globalization Act’ Legislation
• Device Related Provisions of FDA Globalization Act, Draft- (Link)
• Publication: Impact on cosmetics industry (link)

Who should attend?

• Business managers working in FDA regulated industries: US and international
• Device and bio/pharmaceutical companies
• Suppliers to device and pharma companies, e.g., API manufacturer
• Food and cosmetics industry
• Importers of drugs, devices, APIs, food and cosmetics products
• QA managers and personnel
• Site and operations managers
• Regulatory affairs
• Consultants

How to order

Pick one of the options in the table that fits your needs. 

Recorded seminar - Web download Multiple persons - single site Learn at your desk, meet in a seminar or conference room or share the audio file and reference material at your site. Order includes all reference material.	US$ 399.-
Recorded seminar - CD Get the CD in your mail Order includes all reference material.	US$ 399.-
Special offer for Labcompliance Usersclub Members Recorded Seminar- CD or Web download. Order includes all reference material. for Usersclub information and registration, click here	US$ 299.-

About audio seminars

 

Online audio seminars are presented over the phone. During the live presentation attendees can:

1. Study the printed slide material
2. Watch the slides on a computer
3. Watch the slides on a video screen in a seminar room
4. Ask questions through email and web form

 

 About Dr. Ludwig Huber

Dr. Ludwig Huber is the author of the Labcompliance Newsletter. He has been conducting over 100 web and audio or video based seminars since ten years. He is worldwide director for FDA compliance at Agilent Technologies.

Dr. Ludwig Huber is a frequent presenter at IVT conferences and has been awarded as the 'Presenter of the Year' out of 170 speakers. This photo is from IVT's conference on Network Qualification with Ludwig Huber as plenary speaker.

Dr. Huber has published several books related to validation and compliance, for example: Validation of Computerized Analytical and Networked Systems. He was or still is a member of several committees, e.g., of the GAMP Special interest group (SIG) on Laboratory Computers, PDA Part 11 task force, IVT task force on network infrastructure qualification and the European Compliance Academy. He frequently visits FDA in Rockville, VA, and participates in panel discussions with FDA professionals. For more information, click here.