Other related webinars
Essential Regulatory Perspectives and Best Clini...
Monday, 7th February, 2011
Time : 01:00 PM EST | 10:00 AM PST
Biggest challenge for Pharmaceuticals/ Biotechno...
Tuesday, 22nd February, 2011
Time : 10:00 AM | 07:00 AM
Critical aspects of applying QbD to pharmaceutic...
Friday, 6th May, 2011
Time : 02:00 PM | 11:00 AM
Biologics Battlefield: Opportunities and Obstacl...
Thursday, 30th June, 2011
Time : 02:00 PM | 11:00 AM
Vital Success/Failure Regulatory Perspectives an...
Thursday, 15th September, 2011
Time : 02:00 PM | 11:00 AM
Good Laboratory Practices (GLP) Compliance and A...
Friday, 11th November, 2011
Time : 02:00 PM | 11:00 AM
Good Clinical Practice (GCP): FDA Regulations, S...
Thursday, 26th January, 2012
Time : 02:00 PM EST | 11:00 AM PST
Orphan Drugs in Europe – How to use observatio...
Friday, 1st June, 2012
Time : 02:00 PM EST | 11:00 AM PST
Implementing the Compliant Good Laboratory Pract...
Friday, 10th August, 2012
Time : 02:00 PM EST | 11:00 AM PST
An overview of an innovative patient-centric ser...
Wednesday, 12th September, 2012
Time : 02:00 PM EST | 11:00 AM PST
An overview of Translational Medicine
Friday, 21st September, 2012
Time : 02:00 PM EST | 11:00 AM PST
Optimizing Site Selection for Global Clinical Tr...
Friday, 26th October, 2012
Time : 02:00 PM EST | 11:00 AM PST
Optimal clinical supply planning for global drug...
Friday, 16th November, 2012
Time : 02:00 PM EST | 11:00 AM PST
Patient Recruitment & Retention Management in Cl...
Monday, 10th December, 2012
Time : 02:00 PM EST | 11:00 AM PST
GMP's for Dietary Supplements: Keys to Success w...
Thursday, 30th October, 2014
Time : 01:00 PM EST | 10:00 AM PST
Is It Safe? A Cautionary Tale and Practical Guid...
Friday, 9th January, 2015
Time : 02:00 PM EST | 11:00 AM PST
How To Reconcile ICH GCP With RISK BASED Monitor...
Thursday, 19th March, 2015
Time : 11:00 AM IST | 06:30 PM BET
Orphan Drugs : Regulation and Reimbursement Cond...
Friday, 22nd July, 2016
Time : 01:00 PM EST | 10:00 AM PST
Panel Discussion on Best Practices to Clinical T...
Friday, 10th March, 2017
Time : 04:00 PM IST | 11:30 AM BST
FDA Requirements for Good Clinical Practice’s ...
Friday, 7th July, 2017
Time : 04:00 PM IST | 11:30 AM BST
Implementation of Pharmaceutical Quality system ...
Friday, 17th November, 2017
Time : 01:00 PM EST | 10:30 AM PST
FDA Guidance for ICH GCP E6 R2 Means for Sponsor...
Thursday, 27th September, 2018
Time : 04:00 PM IST | 03:30 AM PDT
Managing Human Error in Quality Systems: Human E...
Friday, 17th July, 2020
Time : 01:00 PM EST | 10:00AM PST
FDA approvals of Orphan Drugs and Rare Diseases:...
Friday, 24th July, 2020
Time : 01:00 PM EST | 10:30 AM PST
FDA approvals of Orphan Drugs and Rare Diseases:...
Friday, 26th August, 2022
Time : 01:00 PM EST | 10:00 AM PST
Good Documentation Guideline (Chapter <1029> USP...
Friday, 11th November, 2022
Time : 01:00 PM EDT | 10:00 AM PST
FDA - Investigating OOS results
Friday, 17th March, 2023
Time : 01:00 PM EDT | 10:00 AM PDT
Best Practices for FDA's Investigating Deviation...
Friday, 26th May, 2023
Time : 01:00 PM EDT | 10:00 AM PDT
Recorded Webinar
GMP's for Dietary Supplements: Keys to Success with 21 CFR Part 111
timelapse 60 mins with 10-15 mins of Q and A
Note:
This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times
Speaker/Presenter
Short Abstract
This webinar will prepare you for that inevitable FDA inspection of your dietary supplement manufacturing or distribution facility. You will be measured against 21 CFR PART 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. You must know what this regulation requires and how FDA will do its inspection. Failure to comply with the requirements could lead you down a legal minefield that could cost you your business.
For many years vitamins or dietary supplements were regulated by FDA as foods. There were no regulations defining quality assurance procedures, rather general sanitation and food safety were the rules FDA enforced. So if you kept your facility clean, kept bugs and rodents out, and only used safe ingredients you were free to make as much vitamins or dietary supplements as you wished.
But then things changed. Congress passed the Dietary Supplement Health and Education Act of 1994. Section 9 of that law established the requirement for Good Manufacturing Practices. FDA published those regulations, now in effect as Part 111.
We will discuss all the major sections of Part 111:
| Subpart A--General Provisions | Subpart J--Production and Process Control System: Requirements for Laboratory Operations |
| Subpart B--Personnel | Subpart K--Production and Process Control System: Requirements for Manufacturing |
| Subpart C--Physical Plant and Grounds | Subpart L--Production and Process Control System: Requirements for Packaging and Labeling |
| Subpart D--Equipment and Utensils | Subpart M--Holding and Distributing |
| Subpart F--Production and Process Control System: Requirements for Quality Control |
Subpart N--Returned Dietary Supplements |
| Subpart G--Production and Process Control System: Requirements for Components |
Subpart O--Product Complaints |
| Subpart H--Production and Process Control System: Requirements for the Master Manufacturing Record |
Subpart P--Records and Recordkeeping |
| Subpart I--Production and Process Control System: Requirements for the Batch Production Record |
Who should attend
- From the Dietary supplement Industry: Owners, General Managers, Quality Assurance personnel, and Operations personnel
- From Local Health Departments: Sanitary Inspectors, supervisors
- Anyone whi is interested in learning more on 21CFR Part 111
Content Disclaimer
Contents in our website are from external websites. Links to and content from external website are provided for the convenience of users. Biopractice.com takes no responsibility for the content of such links and websites.