Seminar on Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment – ComplianceOnline


San Francisco, CA (PRWEB) July 24, 2014

ComplianceOnline, the leading governance, risk and compliance advisory network with over 500 experts in various regulatory subjects, today announced a seminar on Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment – Issues and Solutions. The two day seminar led by industry expert Barry A. Friedman will be held on September 8-9, 2014 in San Francisco, CA.

This interactive seminar will cover issues surrounding raw material requirements in a cGMP environment to ensure compliance with Health Canada, FDA, USP and EP regulations.

For more information or to register for the seminar, please click here.

Speaker Barry A. Friedman is a consultant in the biotechnology, regulatory compliance and aseptic processing arena. Dr. Friedman possesses over 30 years of industrial managerial experience in various aspects of biopharmaceuticals and medical devices to include regulatory compliance, expert witness testimony, GLP/GMP, quality control, auditing, sterility assurance, microbiological/analytical validations and fermentation technology.

During the two day seminar, Dr. Friedman will detail raw material requirements in a cGMP environment. He will elaborate regulatory requirements for Phase 1 through commercial manufacturing. Attendees will understand how various types of raw materials may impact the user. Dr. Friedman will also host discussions on topics such as compendial vs. non-compendial testing, use of individual samples vs. composite samples and much more. Case studies will be discussed to illustrate regulatory raw material issues.

This seminar offers a fresh perspective on raw material requirements in a cGMP environment for quality, regulatory and compliance professionals, manufacturing engineers, quality engineers and auditors. Personnel in research and development, microbiology and documentation will also benefit from this training.

Date: Monday, September 8 (8.30 AM- 4.30 PM) and Tuesday, September 9, 2014 (8.30 AM- 4.30 PM)

Location: San Francisco, CA

Registration Cost: $ 1,699.00 per registration

Get 10% Discount for Registration (Use Promo Code – 232082) – please click here.

Register by phone: Please call our customer service specialists at +1-650-620-3937 or email to customercare(at)complianceonline(dot)com

For more information on ComplianceOnline or to browse through our trainings, please visit our website.

About ComplianceOnline

ComplianceOnline is a leading provider of regulatory compliance trainings for companies and professionals in regulated industries. ComplianceOnline has successfully trained over 35,000 professionals from 9,000 companies to comply with the requirements of regulatory agencies. ComplianceOnline is headquartered in Palo Alto, California and can be reached at http://www.complianceonline.com. ComplianceOnline is a MetricStream portal. MetricStream (http://www.metricstream.com) is a market leader in Enterprise-wide Governance, Risk, Compliance (GRC) and Quality Management Solutions for global corporations.

For more information please contact:

A Reuben Bernard

Manager of Program Marketing

ComplianceOnline

2600 E Bayshore Rd

Palo Alto CA USA 94303

650-620-3937 phone

650-963-2530 fax

reuben(at)complianceonline(dot)com

http://www.complianceonline.com







Could the U.S. Mental Health System Have Prevented Elliot Rodger’s Murderous Rampage?


Lexington, KY (PRWEB) May 29, 2014

Elliot Rodger murdered six innocent people and maimed approximately a dozen others before killing himself, according to virtually every major news outlet. “Although one is ‘innocent until proven guilty’ in America, when that individual, caught in the act, takes his own life he gives up his right to a jury trial,” said forensic psychiatrist Dr. Tim Houchin, M.D.

According to this article in Forbes, Rodger posted over a dozen videos on YouTube, each of which has now been taken down. In the article, Forbes writer Kashmir Hill described the videos as being full of “anger, self-loathing and self-pity.” Ms. Hill even reported that one viewer of Rodger’s YouTube videos, just days before the murders, commented on Reddit, “I bet we find out this guy is a serial killer.”

Dr. Houchin is one of a handful of U.S. physicians to be board certified in child and adolescent as well as adult forensic psychiatry. As such, he has evaluated dozens of murderers ranging in ages from teens to the elderly. When asked about Rodger’s YouTube videos Dr. Houchin stated, “Mr. Rodger published multiple disturbing [YouTube] videos in addition to his 140 page ‘manifesto’. These were clearly the actions of a vengeful, emotionally disturbed young man.”

So what exactly was Rodger’s reported psychiatric diagnosis, did it play a significant role in the murders and, perhaps most importantly was this a preventable tragedy? Regarding diagnosis, this CNN article asserts that court documents from his parents’ divorce specify Rodger was diagnosed with Asperger’s syndrome at the age of 7. Another CNN article cited Simon Astaire, a Rodger family friend, as claiming Elliot Rodger met with a psychotherapist “pretty much every day in high school.” The same article reported that Rodger was seeing two different therapists shortly before his murderous rampage.

If the CNN articles are accurate, Rodger had access to tremendous numbers of psychotherapy sessions; something Dr. Houchin indicated is typically only available to wealthy individuals due to the expense of such therapy. When asked if Rodger’s diagnosis of Asperger’s syndrome may have played a role in the killings, Dr. Houchin responded, “Since I have not assessed Mr. Rodger I cannot say whether his purported diagnosis of Asperger’s is accurate. Having said this, if you’re starting with the wrong diagnosis you’re going down the wrong path.”

Although many questions remain, one is especially perplexing. With Rodger posting such disturbing videos on YouTube to the point that even laypersons were commenting he might be a serial killer, why were both of his therapists seemingly oblivious to the fact that he had been planning a mass murder for some 3 years? “This question,” said Dr. Houchin, “is complex and much more information will need to come to light before condemning the decisions of Rodger’s therapists”.

An expanded version of this article is available at 360MentalHealth.com.

About Dr. Tim:

Dr. Tim Houchin is one of approximately 200 physicians in the United States to be triple board certified in psychiatry, child and adolescent psychiatry & forensic psychiatry. In addition to serving as an expert witness to various courts Dr. Tim is founder and president of 360 Mental Health Services, a comprehensive mental health diagnostic and treatment center based in Lexington, Kentucky.







Service Providers in the Gym and Health Club Industry are Now Able to Purchase Insurance Policies That Once Covered Only the Large Establishments


Burbank, CA (PRWEB) July 16, 2013

USA Business is announcing that General Liability Insurance as well as broad coverage insurance plans are now being written for all participants in the Fitness Center Industry. At one time it was believed that these policies were only available to actual full-service gyms and health clubs. Now affordable policies are being written for single providers who offer their professional services at a home studio. This could be a personal trainer, a yoga instructor, Pilates coach, in-home massage therapist and other professionals.

General Liability Insurance can be written for these individuals as well as the brick and mortar businesses. Plans protect the business owner or service provider against claims, by clients who state they were injured while working on the owners machines or slipped and fell in a wet area. Even if the owner being sued is found not responsible for the injury, general liability insurance will cover the legal fees. Some municipalities require minimum limits on bodily injury coverage prior to issuing a business license or certification of occupancy. Owners should keep abreast of these ever-changing limits.

Gym equipment is expensive whether it is present in a home office environment or in a full service health club. Water pipes breaking, a storm causing a ceiling to collapse or any damaging circumstances can render equipment useless. Along with property damage coverage the smaller gym or individual provider may want to include loss of income provisions.

An important area that service providers avoid even though it is a growing concern is Abuse and Molestation Insurance Coverage. In todays environment companies of all classes are very sensitive to this issue and have Human Resource manuals which cover appropriate behavior. Although strict guidelines are enacted to prevent inappropriate behavior on premise, it is important to recognize that rules are capable of being violated by employees and clients alike. Either way a lawsuit can not only hurt the establishments reputation but can be extravagant in legal fees. These cases take highly specialized legal talent as well as expert witnesses. Having this coverage under a fitness center insurance policy will protect the owner or service provider from having to cover legal fees and any settlements out of pocket.

Most states allow suits to be filed against club owners and supervisors of a person who is accused of molestation alleging that there were not proper background checks, on-site security or adequate supervision of the accused. Establishments that offer massages, manicure and pedicures, body waxing and/or personal training are especially vulnerable. What is surprising to many is that humiliation, embarrassment and perceived threats allegedly suffered by a client can fall under Abuse and Molestation Insurance Coverage.

To learn how bundling an insurance policy may be the right decision for a gym, health club or private service provider, go to http://www.businessinsuranceusa.com/fitness-center-gym-commercial-insurance.

About USA Business Insurance: USA Business Insurance writes general liability insurance for every class of business and is educated on specific state requirements. Underwriters examine types of common liability and make sound suggestions based on years of research.







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