Inspection Preparation Procedures}

Submitted by: GRC Training Solutions

Description:

This seminar is intended to discuss what FDA-regulated industry should know about FDAs inspection policy to better implement the best Good Manufacturing Practices (GMPs). The common deficiencies found based on 483s issued to medical device and pharmaceutical industries will be discussed. The most common deficiencies are based on the speakers analysis of 483s issued for the past eight (8) years.

This presentation will greatly help you better prepare for and manage an FDA inspection in a proactive and effective manner.

The speaker will also discuss practical, actionable, and sustainable guidance on how to prepare for a sustainable FDA inspection and how to manage the FDA inspection process including Dos and Donts before, during and after the inspection.

This presentation will provide great opportunities to become familiar with the FDA inspection policy and industrys best GMP practices including the lessons learned from the most common deficiencies observed during the FDA inspections of firms (devices and pharmaceuticals) for the past eight years.

Areas To Be Covered in this Seminar:

Applicable Laws and Regulations

FDA Manuals and Inspection Guides

Hosting an FDA Inspection

Inspection Types and Categories

Inspection Classification

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FDA Forms 482 and 483

Common deficiencies in 483s

What/How to Prepare for and Manage an FDA Inspection

How to Communicate Before, During and After inspection: Dos and Donts

Inspection Preparation Procedures

Close Out Meeting

Responding to 483s, If Issued

How to Communicate with Emotional Intelligence

Employee Training

Actual Case Studies

Speakers PASS-IT Recommendations

Who will benefit:

CEOs

VPs

Compliance Officers

Attorneys

Regulatory Affairs

Clinical Affairs

Quality Assurance

R&D

Consultants

Contractors/Subcontractors

Anyone Interested in the FDA Drug Review and Approval Processes

Instructor Profile:

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past eight years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDAs transparency public meeting in 2009.

GRC Training Solutions is a premier training and solutions company that conducts high impact training’s in Corporate Governance, Regulatory Compliance, Quality Management and Risk Management.

GRC training modules are designed and facilitated by industry experts who possess a strong theoretical and working knowledge of the required regulatory compliance requirements. GRC Training Solutions uses Government and industry best practices and relevant software tools to help companies of all sizes accelerate business performance by helping them understand how to effectively operate within the various guidelines and regulatory frameworks.The training modules are designed for senior and mid level management and executives.

GRC Training Solutions offer companies tailor made solutions that suit different professional needs and are available in different mediums live training sessions at conferences or in-house classroom training, consultation, webinars, seminars and podcasts. Whichever training module the organization opts for- classroom training or webinar each attendee will gain a thorough understanding of the key concepts of Corporate Governance. Even after professionals successfully complete the training sessions, GRC Training Solutions experts are available to answer queries and provide whatever assistance is required.

What makes GRC Training Solutions unique is a proven track record, use of latest technology, updated and engaging training modules and competitive pricing.

Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor.Inspection Preparation Procedures

About the Author: GRC Training Solutions is a premier training and solutions company that conducts high impact training’s in Corporate Governance, Regulatory Compliance, Quality Management and Risk Management.GRC training modules are designed and facilitated by industry experts who possess a strong theoretical and working knowledge of the required regulatory compliance requirements. GRC Training Solutions uses Government and industry best practices and relevant software tools to help companies of all sizes accelerate business performance by helping them understand how to effectively operate within the various guidelines and regulatory frameworks.The training modules are designed for senior and mid level management and executives.GRC Training Solutions offer companies tailor made solutions that suit different professional needs and are available in different mediums live training sessions at conferences or in-house classroom training, consultation, webinars, seminars and podcasts. Whichever training module the organization opts for- classroom training or webinar each attendee will gain a thorough understanding of the key concepts of Corporate Governance. Even after professionals successfully complete the training sessions, GRC Training Solutions experts are available to answer queries and provide whatever assistance is required.What makes GRC Training Solutions unique is a proven track record, use of latest technology, updated and engaging training modules and competitive pricing.For More Details:Email: support@grcts.comTel: +1-248-233-2049Web:

grcts.com

Source:

isnare.com

Permanent Link:

isnare.com/?aid=1959759&ca=Real+Estate }

on March 20th, 2017 | File Under Medicine | No Comments -

Cosmetic Surgery:Is It For You?}

Cosmetic Surgery:Is It For You?

by

Marcus Landauer

If you thought cosmetic surgery was reserved for Hollywood stars, you’re out of sync with the times. Nowadays it’s become a surprisingly affordable lifestyle choice for people from all walks of life. Here’s a look at some of the more common cosmetic procedures to help you decide if cosmetic surgery is for you.

Essentially, cosmetic surgery is a surgical procedure carried out to improve a person’s appearance. As such, it can be applied to any part of your body. But the most common are the various regions of the face, the breasts and the waist. Let’s look at each in turn.

The most famous facial surgery procedure is the facelift (rhytidectomy). The objective is to tighten up skin and smooth out the lines and wrinkles that time etches on your face. The end result is a more youthful appearance.

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The second most common is the nose job (rhinoplasty). This works to bring balance to the face by changing the shape of your nose, by making it wider or narrower, for example. It’s also used to remove bumps in the nose.

Then there’s eye enhancement. This procedure centres on removing unsightly bags under the eyes.

Lesser known is ear surgery. This is for people who feel their ears are too prominent. The operation adjusts the shape of the ear cartilage so that the ear lies closer to the head.

Next is breast surgery which involves altering the size and/or position of the female breast. The most sought after procedure is breast enlargement which is achieved through implants. Another popular procedure is the uplift which corrects sagging breasts. Finally there’s breast reduction for women who suffer from back or shoulder pain due to excessive breast weight.

Finally, body surgery involves ways to improve the shape of the body, particularly the waist. The two most popular procedures here are tummy tucks and liposuction. The tummy tuck involves removing folds of overhanging skin and fatty tissue from around the midriff to give that smooth, tight, youthful look. For moderate weight reduction, liposuction is available. This involves the selective removal of fat cells by vacuum suction through a small metal tube inserted into the affected areas.

These are the most popular cosmetic surgery procedures. But in addition to the above, there are also more specialized procedures such as weight loss surgery, cosmetic surgery for men and anti-aging cosmetic surgery. Your surgeon can give you details of these.

In deciding whether to go ahead with cosmetic surgery, the first step is to consult a surgeon to determine whether you are a suitable candidate. The surgeon will take many factors into account such as your age, state of health, skin texture, bone structure and healing ability. Though most cosmetic surgery procedures are safe and carried out under local anaesthetic, there are risks involved and your surgeon will make you aware of them.

Another key factor is how realistic your expectations are about the results of your surgery. If you’re expecting to be transformed into a clone of Julia Roberts, you’re probably setting yourself up for disappointment. Results tend to be subtle rather than transformational and it’s important to remember this. However, they can be life changing too.

Marcus Landauer is an expert consultant with over 12 years experience in

plastic surgery

and

cosmetic surgery

.

Article Source:

eArticlesOnline.com

}

on December 17th, 2016 | File Under Medicine | No Comments -