Coordinated Chaos in the Cell’s Cytosol

The American Society of Cell Biology Presents the Following Educational Video

Watch Penguins of the Antarctic

Nature Documentary

NATURE braves the extreme conditions of Earth's southernmost continent for a close-up look at the varied Penguins of the Antarctic. As night falls in Antarctica, biting winds cast horizontal snow across the dark backs of a mass of huddled emperor penguins. The temperature is 50 below zero, the gales are 90 miles per hour, and the sun won't rise again for more than two months. 

NATURE captures these amazing — and well-dressed — flightless birds shivering on the ice as well as gliding through their most comfortable element, the water — a balmy bath compared to the air temperature above — where the emperors can hold their breath up to 20 minutes and dive a mile deep. Meanwhile, on the shores of Zavodovski Island, an active volcano, two million chinstrap penguins breed and travel on their own "superhighway" between the sea and their colonies on higher ground — taking care to evade the occasional 12-foot long leopard seal, which can consume six penguins in an hour.

Compiled Resources Helpful for the RAC Exam Preparation Offered by RAPS

The following provides compiled resources helpful for those preparing for Regulatory Affairs Certification (RAC) exam offered by the Regulatory Affairs Professionals Society (RAPS).

Learn about the Regulatory Affairs Certification (RAC) from RAPS.

What’s in it for you (and your employer)

Obtaining and maintaining your RAC demonstrates the core knowledge and applied critical thinking skills of the most accomplished professionals in the regulatory field. The rigorous exam puts your regulatory knowledge to the test.

If you have more than three years of regulatory affairs experience, it may be time to invest in yourself and earn this coveted credential. With it, you can do more for your employer… and earn more along the way.

See more >>

1). Facebook Study Group 

The Facebook study group has been launched for professionals to share useful information and tackle questions and answers in the US and global reulatory affairs, intending to help those professionals prepare easier and better for Regulatory Affairs Certification (RAC) exams for US, EU, Canada and Global.

2). Quizlet 

3). USC Information 

4). LIVE Seminar: How to Most Effectively Prepare for the US RAC Exam

Having a credential for Regulatory Affairs Certification (RAC) can add a great value to one’s professional experience and achievement. Significant benefits of how to effectively study and prepare for the RAC examination may have been frequently neglected or considered less important, leading to spending a lot more than what is reasonably necessary to pass the exam and in many cases, professionals re-take the exam more than once. This seminar ($49) provides a great overview of what and how to most effectively prepare for the RAC exam.

5). LinkedIn Group for US RAC 

6). 21 CFR Food and Drugs 

7). Download Key FDA Regulations in PDF 

8). FDA Combination Product 

9). Medical Device Promotion and Advertising

FDA issues new draft documents related to compounding of human drugs

Documents include draft guidances on outsourcing facility registration; outsourcing facility adverse event reporting; drug repackaging; mixing, diluting, and repackaging biological products; and a draft Memorandum of Understanding with the states.

February 13, 2015

Today, the U.S. Food and Drug Administration issued five draft documents related to drug compounding and repackaging that will help entities comply with important public health provisions.

The draft documents are applicable to:

• pharmacies
• federal facilities
• outsourcing facilities
• physicians.

The new category of outsourcing facilities was created under the Drug Quality and Security Act (DQSA), enacted by Congress in November 2013 in response to a deadly fungal meningitis outbreak that was linked to contaminated sterile compounded drug products.

Drugs compounded in an outsourcing facility that meet certain conditions may be entitled to exemptions from certain provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), including the new drug approval requirements and the requirement to label drug products with adequate directions for use.

Outsourcing facilities are subject to current good manufacturing practice requirements and inspections by the FDA according to a risk-based schedule.

Drugs produced by compounders that are not registered as outsourcing facilities must meet certain other conditions described in the FD&C Act, or they will be subject to all of the requirements applicable to drugs produced by conventional drug manufacturers.

“The draft guidance documents provide information to pharmacies, outsourcing facilities, health care entities, and others about these FDA-proposed policies, which are critical to protecting the public health,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.

Download Free Here >>

Dr. David Lim provides regulatory consulting and training services for medical products regulated by the US FDA, an Agency under the US Department of Health and Human Services (DHHS).

FDA Guidance for Medical Food

Guidance for Industry Frequently Asked Questions About Medical Foods; Second Edition Draft Guidance

August 2013

Frequently Asked Questions About Medical Foods 

This guidance is intended to provide industry with a convenient place to find answers to frequently asked questions (FAQs) about medical foods.

This draft guidance, when finalized, will represent the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the telephone number listed on the title page of this guidance. 

Dr. David Lim provides regulatory consulting services for medical products regulated by the US FDA, an Agency under the US Department of Health and Human Services (DHHS).

How to Most Effectively Prepare for the US RAC Exam

LIVE Online Seminar: How to Most Effectively Prepare for the US RAC Exam

• Date: February 9, 2015 and March 9, 2015
• Time: 11:00 AM PST | 02:00 PM EST
• Duration: 90 Minutes

About the Seminar

Having a credential for Regulatory Affairs Certification (RAC) can add a great value to one’s professional experience and achievement. Significant benefits of how to effectively study and prepare for the RAC examination may have been frequently neglected or considered less important, leading to spending a lot more than what is reasonably necessary to pass the exam and in many cases, professionals re-take the exam more than once. 

*: RAC stands for Regulatory Affairs Certification. In this case, it refers to the US RAC examination.  

Understanding what and how to study the relevant subjects is one of the first steps and is considered to be the most effective strategy.  An effective preparation of the RAC examination can save a significant amount of your resources (time, energy and money) and beyond (sometimes, saving some level of embarrassment).

This  seminar is intended to help you effectively prepare for the US RAC examination using a CAC-SI method.  CAC-SI in this case refers to a Current, Accurate, and Comprehensive study and understanding in a Systematic, Integrated Manner.

In this 90-min presentation, the speaker will guide you through the details of the contents for you to study (namely, WHAT and HOW) and grasp so that you can be well-prepared for the RAC exam.  

At the end of the presentation, you should be able to come up with your customized, well-guided, actionable strategy to most effectively prepare for and pass the US RAC examination. 

About the Areas to Be Discussed

• 1st 45 Minutes
  • Overview of the US RAC Exam
  • Subject Areas
  • Applicable Laws and Regulations
  • Areas in Pharmaceuticals
  • Good Laboratory Practice (GLP)
  • Good Clinical Practice (GCP)
  • Good Manufacturing Practices (cGMPs)
  • Investigational New Drug Application (IND)
  • New Drug Application (NDA)
  • FDA Guidance Documents
  • Review of Practice Questions
• 2nd 45 Minutes
  • Subject Areas for Biologics and Medical Devices
  • Applicable Laws and Regulations for Biologics and Medical Devices
  • Biological Products
  • Licensing Biologics 
    General Biological Products Standards
  • Investigational Device Exemption
  • Premarket Notification (510(k))
  • Premarket Approval (PMA)
  • Good Manufacturing Practices (cGMPs) for Medical Devices
  • FDA Guidance Documents
  • Review of Practice Questions

NOTE:  Your attendance of this seminar will save your enormous amount of time, energy and efforts while preparing for your successful RAC examination.  

About the Intended Attendee(s)

• Regulatory Affairs
• Scientists
• Engineers
• Healthcare Professionals
• Consultants
• Anyone interested in the topic

Global Compliance Seminar Speaker: Dr. David Lim

Dr. David Lim, Ph.D., RAC, ASQ-CQA 

Dr. Lim is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.com).  Dr. Lim frequently presents global regulatory and quality compliance topics at Global Compliance Seminar and 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 seven 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 FDA’s transparency public meeting in 2009.  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.  Dr. Lim serves as a member of the Advisory Board for Inspection Insider published by FDA News.

Dr. David Lim provides regulatory consulting services for medical products regulated by the US FDA, an Agency under the US Department of Health and Human Services (DHHS).