CHPA’s e-learning program focuses on timely and topical consumer healthcare industry issues in a convenient and educational online format to fit into your busy schedule. 

Each webinar provides a valuable way for you to stay educated on the industry topics that impact your business and bottom line, saving you time and money without requiring travel or time away from the office.

CHPA webinars will give you same-day strategies and “must-use” techniques to use as soon as the webinar is over, and you can participate from anywhere with a phone, computer, and internet access.

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Upcoming Live Webcasts
Collapse Managing Foreign Inspections/Foreign Supplier Inspections

Have you wondered why your foreign suppliers: API, intermediates, food ingredients, etc. are suddenly in trouble with regulatory authorities? Did they just go astray or is your auditing program not performing as designed? Learn from an expert who has helped companies manage through nearly 100 FDA inspections of foreign facilities around the world. Mr.Saxon will explain common findings, how to handle inspection observations, cultural issues that may be at play, and where the most serious issues are often found. His expertise could be of value to anyone who manages FDA inspections of foreign facilities.

 

 

Presented by CHPA/EAS Consulting Group, LLC

Moderated by Barbara A. Kochanowski, Ph.D., Senior Vice President, Regulatory & Scientific Affairs, CHPA 

 

Formats Available: Webinar + Archive
Original Seminar Date: January 30, 2018
MORE INFOMORE INFO Managing Foreign Inspections/Foreign Supplier Inspections
Collapse Adverse Event Reporting - What You Need to Know

Serious Adverse Events are and important FDA requirement for over-the-counter (OTC) drugs and dietary supplement in the United States. Learn the background and history of SAE reporting regulations, the challenges of deciding what constitutes a SAE, when and how to report an Adverse Event as well as the differences between reporting requirements for OTC drugs and dietary supplements vs. requirements for cosmetics. 

 

Presented by CHPA/EAS Consulting Group, LLC

Moderated by Marcia D. Howard, Ph.D., Senior Director, Regulatory & Scientific Affairs, CHPA

Formats Available: Webinar + Archive
Original Seminar Date: February 20, 2018
MORE INFOMORE INFO Adverse Event Reporting - What You Need to Know
Collapse Conducting a Scientifically Sound Out of Specification (OOS) Investigation

Good Manufacturing Practices (GMPs) are a critical component to the overall regulatory environment of a dietary supplement laboratory and understanding how to implement a strong quality system based on scientifically sound analytical and/or microbiological techniques is key.  This laboratory quality system is most important when required raw material and finished product specifications for identity, purity, strength, composition, and limits on potential contaminants are not met.  When this happens, an Out of Specification (OOS) investigation must be conducted to determine whether the original OOS result is valid; and this must be accomplished in a timely, unbiased, and well-documented manner. Each OOS investigation must also be scientifically sound and thorough enough to get to the root cause of the OOS result. Appropriate Corrective and Preventive Actions (CAPAs) should then follow to ensure that the correct result is ascertained and that any errors are systematically prevented from reoccurring.  The performance of inadequate OOS investigations has historically been one of the most frequent citations on FDA issued List of Observations, more commonly referred to as Form 483s.

 

Presented by CHPA/EAS Consulting Group, LLC

Moderated by John Punzi, Ph.D., Quality Assurance & Technical Affairs, CHPA

 

Formats Available: Webinar + Archive
Original Seminar Date: March 06, 2018
MORE INFOMORE INFO Conducting a Scientifically Sound Out of Specification (OOS) Investigation
Collapse Managing FDA Inspections

FDA inspections are a very important part of how FDA evaluates company compliance with laws and regulations they enforce and they also serve as one of the principle ways FDA gathers evidence of non-compliance with laws and regulations. This webinar will give an overview of the FDA inspection planning process and an understanding of what to expect during the FDA inspection. It will also provide guidance concerning how to prepare and plan for the FDA inspection. 

 

Presented by CHPA/EAS Consulting Group, LLC

Moderated by Barbara A. Kochanowski, Ph.D., Senior Vice President, Regulatory & Scientific Affairs, CHPA

Formats Available: Webinar + Archive
Original Seminar Date: April 03, 2018
MORE INFOMORE INFO Managing FDA Inspections
Collapse Responding to 483s and Warning Letters

It is extremely important to promptly respond to any correspondence from FDA, particularly the FDA-483 or a Warning Letter. If a prompt complete response is made to the FDA-483 the company may avoid receiving a Warning Letter. If no response, or an inadequate response is made it is very likely that FDA will issue a Warning Letter to the company. If a foreign firm receives a Warning Letter from FDA the company will most likely be place on an Automatic Detention list which means that none of their products will be permitted entry into the United States until the issues are corrected and FDA has verified the corrections. That is a very long process and will take many months to a year or more. For domestic firms this could be the beginning of further, much more serious regulatory action by FDA. This webinar will explain the FDA processes and provide guidance on how to manage these issues.

 

Presented by CHPA/EAS Consulting Group, LLC

Moderated by Jay Sirois, Ph.D., Senior Director, Regulatory & Scientific Affairs, CHPA

 

Formats Available: Webinar + Archive
Original Seminar Date: April 17, 2018
MORE INFOMORE INFO Responding to 483s and Warning Letters


Access CHPA Webinar Archives

CHPA's e-learning program focuses on timely and topical consumer healthcare industry issues in a convenient and educational online format to fit into your busy schedule. Since 2012, CHPA has hosted a myriad of webinars, of which 14 are available on-demand for you to purchase right now. Take a look at our three purchase options below, and take advantage of our discount opportunities so you have same-day strategies and "must-use" techniques at your fingertips 24/7!

Purchase Options

•  Single Archive Purchase: $199 member, $249 nonmember: Access to any one webinar archive, on-demand any time. Each additional webinar archive will be $199 member, $249 nonmember

Click here to view all available webinar archives for purchase.


•  "Pick 5" Bundle Archive: $499 member, $549 nonmember: Pick 5 webinar archives to access any time.

Click here to purchase “Pick 5” webinar bundle.

•  Unlimited Archive Pass: $999 member, $1049 nonmember: Access to all webinar archives, any time.

Click here to purchase “Unlimited Archive Pass".