PART 1 — EXPLORING GOOD MANUFACTURING PRACTICES UPDATES AND FDA REGULATORY EXPECTATIONS
Tuesday September 18, 2018
12:00 pm – 1:30 pm EDT
Instructor: Barry A. Friedman, Ph.D.
Annual Good Manufacturing Practices (GMP) updates are required by the FDA to assure facility personnel maintain a current understanding of regulatory requirements. These regulations utilize 21 CFR Parts 210/211 as the basis for understanding of the drug regulations; however, many other documents to include FDA’s Guidance(s) for Industry, and various other policies, to include ICH Q7, Q8, Q9, Q10, and Q11 enhance the basis for these updates and regulatory expectations.
This Executive Conference Corp. (ECC) interactive two session webinar series will serve as a refresher course for those involved in the pharmaceutical and biotechnology arena. Highlights of Part I of the two seminars will include (1) what is happening within the FDA, (2) a review of the six systems the FDA use within their abbreviated and full inspection audits and why they may choose one over the other, (3) changes to 21 CFR Parts 210 and 211, and (4) the “New” Process Validation which became available as a FDA Guidance for Industry in January 2011.
The webinars will also use Warning Letters to illustrate some of the common repeated errors that companies encounter within 21 CFR Parts 210/211 and how incorrect responses may amplify their problems.
The objective of these live and interactive ECC two session webinar series is to explore GMP updates and FDA regulatory expectations and assist in assuring that your organization is maintaining itself within a cGMP compliance framework. Please plan to attend with an interdisciplinary group to get the most from this two part webinar series.
Learning benefits will include:
- Learning how GMP Compliance can enhance the Efficiency of your Organization
- Determining if your Organization is meeting all Six Quality System Requirements
- What’s happening within the FDA
- How the revised 210/211 is allowing for Automated Equipment
- The “New” Process Validation — An Overview of What It Includes
- What Happened to “Retrospective Validations” and What Happens Now
- How to use a Warning Letter to Improve the Quality within your Facilities
- An Opportunity to Learn how others are meeting cGMP needs during the “live” Question and Answer Session
Fee:
$385 for one person
$700 2-5 people
$999 6-10 people
Questions? support@eccwebinars.com
ECC-056