3 Exclusive Webinars on FDA Compliance for Pharmaceutical Organizations

The pharmaceutical business is subject to a number of regulations imposed by Food and Drug Administration (FDA). These regulations enforce stern norms on pharmaceutical companies to safeguard the safety and benefits of the products made by them. This course is designed to provide an internal understanding of the parameters for regulatory compliance, successful approaches to compliance, and meeting the concerns of regulators.
Instructor: Camille Davis Thornton, James R Harris, Charles H Pierce
Product ID: PACK70008

CD/Recorded-How It Works:

  • Webinar CD/Recorded will have a series of modules. Our experts have delivered the modules using PowerPoint Presentations.
  • Webinar Recording Link or CDs are licensed to be used multiple times at any location with multiple attendants, as you wish.
  • Recording links will be valid up to 6 months with unlimited access and reference materials will be mailed to your registered e-mail.
  • Free shipment of CDs within 72 hours from the date of purchase and reference materials will be mailed to your registered address.

Webinar Topics:

Who will benefit?

These webinar will be beneficial to the following:

QA/QC, Administrative and Project Managers | Drug manufacturers including prescription, over-the-counter (OTC), active pharmaceutical ingredient (API), homeopathic, and medical gas | Consultants | Principal Investigators and sub investigators | Clinical Research Scientists (PKs, Biostatisticians etc) | Safety Nurses | Clinical Research Associates (CRAs) | Clinical Research Coordinators (CRCs) | Recruiting staff | Regulatory Affairs Professionals | Data managers

Webinars included in the Package:

Submitting FDA Electronic Regulatory Filings – Drug Establishment Registrations and Drug Listings (Duration: 60 Minutes)

US Food and Drug Administration (FDA) now requires electronic submission for labeler code requests, drug establishment registrations, drug listings, annual renewals, and updates. The electronic process replaces FDA paper forms 2656 (Registration of Drug Establishment/Labeler Code Assignment), 2657 (Drug Product Listing), and 2658 (Registered Establishments’ Report of Private Label Distributors). To transmit files, companies must use the FDA’s Electronic Submission Gateway (ESG). According to FDA, moving from a paper-based format to an electronic system has improved the timeliness and accuracy of submissions. This webinar will provide clarification on the process of submitting drug establishment registration and drug listing information to the FDA.

Objectives of the Presentation:

  • Overview of FDA drug establishment and listing requirement
  • Transition from paper-based to electronic process
  • Creation of electronic files
  • Extensible Markup Language (XML)
  • Structured Product Labeling (SPL)
  • Codes and code sets
  • Establishing FDA Gateway (ESG) account
  • Submission to ESG
  • Checking drug establishment registration and listing status

Instructor Profile:

Camille Davis Thornton, M.S., RAC is the founder of MACE Concepts, LLC, an independent consultancy specializing in providing innovative regulatory, compliance, and training solutions. Ms. Thornton has an M.S. in Biotechnology from The Johns Hopkins University and certifications from the Regulatory Affairs Professionals Society (RAC-US) and the National Restaurant Association (ServSafe® Food Protection Manager, Instructor, and registered Examination Proctor). Additionally, she has over 15 years of experience in multiple regulated industries and actively teaches at the college level.

FDA's New Guideline regarding Contract Manufacturing Arrangements for Drugs: QUALITY AGREEMENTS (Duration: 60 Minutes)

This presentation outlines the contents of the FDA's Industry Guidance draft document titled Contract Manufacturing Arrangements for Drugs: Quality Agreements issued in May of 2013. While this was issued as a draft document, we know that while there may be some changes in wording, this Guidance Document is notification of FDA thinking and will be enforced as a cGMP document.

This guidance defines a Quality Agreement, what it should contain and responsibilities of both the product owner and the contract manufacturer. This is information that is critically important to all pharmaceutical manufacturers.

Instructor Profile:

Dr. Harris has over 25 years of senior level pharmaceutical industry experience. Following this and for the past 15 years, he operated a global consulting firm that provided guidance to firms in over 60 countries around the world. During his tenure in the pharmaceutical industry, he was very active in industry groups. He served on the PMA's Validation Advisory Committee and was chairman of the Computerized Systems Advisory committee where he wrote the original guideline on computer validation and negotiated its acceptance with FDA.

FDA Regulatory Control of the Drug Development Process and Investigator Responsibility in the Process (Duration: 90 Minutes)

When the PI signs the FDA form 1572 (for IND studies) or the "Statement of the Investigator (for IDE studies), she / he is signing a legally binding document committing themselves to follow all of the appropriate regulations. In the FDA form 1572, the Investigator signs an agreement that has 9 statements, 7 of which begi n with "I agree".

Objectives of the Presentation:

  • The Investigators role in the clinical research process, the IC process
  • Know how the Regs define the many terms describing Adverse Events
  • Why the investigator files the signed and dated protocol?
  • What is the legal language of the FDA form 1572 or Device equivalent?
  • Why is Financial Disclosure information important?
  • What is the history of the drug / device regulations?

Instructor Profile:

Charles H. Pierce, MD, PhD, FCP, CPI is a consultant in the Clinical Research / Drug-Device Development arena specializing in bringing the message of GCP Regulations and Investigator esponsibility to the entire investigative team to help them understand the regulations as well as the ethics of research involving human subjects.Dr. Pierce has served as an advisor to several clinical research organizations.

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