FDA Audit Checklist Clinical Trials Seminar 2018

  • Check with publisher
  • Published date: March 6, 2018
    • Seattle, Washington, United States

Overview:

FDA's inspection program follows well-established procedures and conducts the inspections with as much consistency as possible. FDA trains its investigators from day one. During the first six months, they attend extensive classroom and hands on training. FDA investigators learn basic skills. As time goes on, special training is given and the field staff use detailed reference materials to guide their thinking, actions, decisions and conclusions. If you understand FDA's management of its investigators and inspectional process, you can keep your establishment ahead of a needless regulatory disaster. FDA conducts inspections with standard operating procedures and detailed information on how to handle almost any situation the FDA investigator may face. The course will let you see inside an FDA investigator's mind set and what the agency will do when it evaluates what the investigator says and documents. What the investigator does and what FDA does are not mysteries, they just seem like it.

Why you should attend:

"Hi, I'm from the FDA and here to conduct an inspection." What is the first thing you do? Ring a fire alarm, close down for the day (some firms have) or do you follow well-planned protocol. You think, "Why is FDA here? Are we in trouble?" Are you prepared to talk about the trouble you know you have with FDA regulations or is your plan of action to cross your fingers.
We all know that a bad FDA inspection has immediate and long-term consequences. The cost of fixing your problems, the bad public relations, upset customers and future business plans can be set into a downward spiral. If you do not understand what FDA is doing or thinking, how can you expect to deal successfully with FDA? If you don't know how to anticipate an investigator's actions or follow their train of thought, you will not be able to mitigate the effect of inspectional findings.
"Is FDA going to send us a Warning Letter?" You can make a reasonable prediction if you understand your inspectional results and how FDA will "grade" it. The tools are available.

Areas Covered in the Session

• FDA legal authority
• Types of inspections
• FDA investigator training
• FDA's written procedures, policy and operations guide
• Industry inspection protocol
• What to do and not do during an inspection
• Form FDA 483 response
• Warning Letter response
• Enforcement

Who Will Benefit:

• Regulatory Affairs
• Quality Assurance
• Manufacturing
Location: Seattle, WA Date: April 26th & 27th, 2018 and Time: 9:00 AM to 6:00 PM
Venue: Courtyard Seattle Sea-Tac Area 16038 West Valley Highway Tukwila Washington 98188 USA

Price:

Register now and save $200. (Early Bird)
Price: $1,295.00 (Seminar Fee for One Delegate)
Until March 10, Early Bird Price: $1,295.00 From March 11 to April 24, Regular Price: $1,495.00
Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*
Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)*

Contact us today!

NetZealous LLC DBA GlobalCompliancePanel
john.robinson@globalcompliancepanel.com
support@globalcompliancepanel.com
Toll free: +1-800-447-9407
Phone: +1-510-584-9661
Website: http://www.globalcompliancepanel.com

Registration Link - https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901411SEMINAR?april-2018-seo-science-marketplace.org
Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/
Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/
Follow us on Twitter: https://twitter.com/GCPanel

Result 0 votes
John Robinson
0 votes

Useful information

  • Avoid scams by acting locally or paying with PayPal
  • Never pay with Western Union, Moneygram or other anonymous payment services
  • Don't buy or sell outside of your country. Don't accept cashier cheques from outside your country
  • This site is never involved in any transaction, and does not handle payments, shipping, guarantee transactions, provide escrow services, or offer "buyer protection" or "seller certification"

Related listings

  • Webinar On HIPAA 2019 and Beyond

    Webinar On HIPAA 2019 and Beyond

    Medical - Health Fremont (California) December 14, 2018 Check with publisher

    Overview: This 90-minute webinar will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order as HIPAA is now fully enforced and the government is not using kid gloves any more. It will also address ...

  • Webinar On Healthcare Coding, Billing and Reimbursement: An Overview

    Webinar On Healthcare Coding, Billing and Reimbursement: An Overview

    Medical - Health Fremont (California) December 14, 2018 Check with publisher

    Many people work with various aspects of healthcare coding and billing but may not understand how providers generate their claim data, how they report the data to payors, and how payors use that information to reimburse providers. This webinar provid...

  • 3-Hour Virtual Seminar on Most Significant Risks under HIPAA

    3-Hour Virtual Seminar on Most Significant Risks under HIPAA

    Medical - Health fremont (California) December 14, 2018 Check with publisher

    Overview: This 3-hour webinar will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits occur. It will also address major changes under the Omnibus Rule and any other ap...