PART II — EXPLORING ADDITIONAL GOOD MANUFACTURING PRACTICES UPDATES AND FDA REGULATORY EXPECTATIONS
Tuesday September 25, 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.
In the second of this two part interactive Executive Conference Corp. (ECC) webinar series, additional areas will be reviewed. Highlights of Part II of the two part webinar series will include: (1) Combination Products codification of the rules, (2) Investigating Out-of-Specification test results (OOS), (3) 21 CFR Part 11, (4) USP<61>/<62>, and (5) Quality Risk Management (ICH Q9).
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 this 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:
- Codification of Combination Rules – Why Everyone is Affected
- The Issues Surrounding Out of Specification Results and Why this Guidance for Industry Document continues to cause Industry Problems
- The Revisions to USP<61>/<62> Microbiological Examination of Non-sterile Products, and the Pitfalls Awaiting the Laboratory
- How ICH Q9, Quality Risk Management, can Benefit your Organization
- 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-057