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AAHP Webinar: Annual Reporting of Quality of Listing Drugs Manufactured
December 10, 2021 @ 12:00 pm - 12:30 pm EST
Meeting FDA's New Annual Reporting Requirement
Is your firm ready to meet its new obligation to report quantities of drugs manufactured? Is your staff prepared to provide the level of detailed information in the necessary format for submission? Are you overwhelmed with the thought of tackling this new requirement and submitting the information in the next 10 weeks?
The AAHP brings you a 30-minute webinar to get your company well on its way to fulfilling this task with a minimum of pain and effort. Leonard Krause (of AAHP member FDA Connect) will provide the answers to two fundamental questions:
- What is required of your company?
- How do you submit the necessary information?
More importantly, Leonard will provide you and your team an overview of the steps and process to comply. With the clear roadmap he provides, your company will find this undertaking less involved and complex than it looks right now.
This reporting requirement applies to your company if it manufactures, repackages, or relabels any drug products, including homeopathic drugs. If these production steps are done on your behalf, your company is still responsible for assuring the reporting is done in a timely manner for your products; otherwise, your products could be at risk.
The reporting requirement is easiest to fulfill when your team understands what information is needed and why; then they can best support the person(s) undertaking the actual reporting task.
What You'll Learn:
- How you need to prepare your company to meet its new FDA reporting obligation
- The steps and process needed to be in compliance
Be prepared for the upcoming February 2022 submission deadline as well as the subsequent reporting deadline in May 2022.
This economical 30-minute virtual webinar can be an integral part of your company’s obligatory training to help fulfill your cGMP compliance requirements.
Cost is only $49. AAHP members will receive a full rebate after the webinar.
Sign up here. As many can attend at a registered location as feasible.
PRESENTER
Leonard Krause
Founder and President
FDA Connect, Inc.
Leonard Krause, founder and president of FDA Connect, Inc., has 30 years’ experience working in the field of government compliance and market research. FDA Connect specializes in serving the homeopathic pharmaceutical industry. This Oregon-based consulting company offers electronic registration and product listing services to FDA on behalf of homeopathic and OTC drug manufacturers and marketers, as well as product label reviews and GNP due diligence audits of CMO's on behalf of Private Label Distributors. Contact Leonard by phoning 541-232-3030 or by emailing lkrause@fda-connect.com.
WHEN
Friday, December 10
12:00 - 12:30 p.m. EST
WHERE
Zoom Webinar
PRICE
$49 per attendee
AAHP members will receive a full rebate after the webinar.
For questions, contact Eric Foxman (info@aahp.info) or Alissa Gould (alissa.gould@boiron.com)
Who Should Attend?
- Management and staff responsible for inventory control.
- Management and staff responsible for warehousing/shipping.
- Management and staff responsible for overseeing sales volumes.
- Management and staff responsible for regulatory compliance.
- Senior management assuring your company meets its regulatory obligations.