Engaged. Knowledge. Application
Supplier Qualification CONTENT Package
20 page article, an assessment plan with over 80 individual items from 20 major compliance areas, PowerPoint training presentation and trainer instructional notes
➢ 1. Supplier Qualification Programs: Establishment and Implementation (Article)
To View Complimentary Excerpt - click here
➢ 2 & 3. Supplier Qualification Programs: Establishment and Implementation (PowerPoint Training Presentation and Trainer Instructional Notes)
➢ 4. Supplier Assessment Plan Considerations (Checklist)
To View Complimentary Excerpt - click here
1. Supplier Qualification Programs: Establishment and Implementation (Article)
To View Complimentary Excerpt - click here
This 20-page article serves as a comprehensive resource in establishing and implementing an effective supplier qualification program. It reviews the following subject matter content below:
➢The components of supplier selection
- Process elements
- Material specifications
- Change control
- Customer inspection
- Supplier reporting
- Decertification
➢Part 210 & 211 GMP requirements, including an in-depth review of Subpart E-Control of Components and Drug Product Containers and Closures
- 211.80 General requirements
- 211.82 Receipt and storage of untested components, drug product containers and closures
- 211.84 Testing and approval or rejection of components, drug product containers and closures
- cGMP requirements: what information do they provide?
- Certificate of Analysis (COA) records
- Reduced testing
➢Establishing a supplier qualification program
- Getting started
- Supplier qualification system
➢Supplier qualification program design principles
- Taking a closer look
- Supplier testing
➢Meeting quality requirements
- Defining excipient cGMP standards
- API quality standards
- Supplier quality assessments
- Quality auditing
- Critical areas
- Interactions between QA, purchasing, QC and production
- Utilizing quality agreements
- Managing change
- Impact of change
2 & 3. Supplier Qualification Programs: Establishment and Implementation (PowerPoint Training Presentation and Trainer Instructional Notes)
This 14 page PowerPoint Training Presentation includes subject matter presented in the article above. This ready made presentation includes Trainer instructional notes, which contain 25+ discussion points related to the PowerPoint training presentation. Trainer instructional notes are designed to focus your presentation, engage attendees and encourage their participation in your training.
4. Supplier Assessment Plan Considerations Checklist
To View Complimentary Excerpt - click here
Over 20 major compliance areas (80 individual items) are captured in this comprehensive checklist related to assessing your suppliers.
Supplier Qualification CONTENT Package is only $99.00
Comment
Contact enKap
enKap Terms and Conditions
enKap Terms and Conditions
All sales are final
Legal Disclaimer
This product and any of its enclosures, attachments or appendices, references to online information, conferences or preparations of materials in a variety of formats are created to provide you with accurate and authorative information concerning the subject matter covered. However, this product and any other ancillary items disseminated in connec-
tion with same are not necessarily prepared by a person licensed to practice law in a particular jurisdiction.
enKap, Inc. is not engaged in rendering legal advice, and this product is not a substitute for the advice of an attorney. If you require legal or other expert advice, you should seek
the services of a competent attorney or other professional.
enKap, Inc. necessarily is not, cannot and will not be liable for any claims, damages, or regulatory legal proceedings initiated as a consequence of you, the customer, modifying,
altering, adding to or deleting portions of any product initially provided by enKap, Inc.
Once any original document provided by enKap, Inc. to you, whether in print or electronic format, has been manipulated or customized by you, then the responsibility for the
document’s accuracy, correctness, and compliance are solely yours.
If any action, claim for damages, or regulatory proceedings is commenced against enKap, Inc. as a consequence of your alteration or modification, etc. of the document templates
or other originally provided materials, then and in that event, you agree to indemnify enKap, Inc. for such claims, and for any attorney’s fees expended by enKap, Inc. in connec-
tion with defense of same.
© copyright 2012 enKap
© 2012 Created by enKap.
You need to be a member of enKap community to add comments!
Join enKap community