Engaged. Knowledge. Application
NEW BOOK
Wouldn’t it be great if people were actually interested and excited about attending GMP training? If you would like to make your training more engaging, and are interested in learning how to do so, read this book! Read More - Click Here.
Join Your Peers...
Join Your Peers Today from Johnson & Johnson, Baxter, Merck, U.S. FDA, Boston Scientific, Covidien, Novartis, Pfizer, AstraZeneca, Medtronic, Cordis, Lifescan, and more…
➢BE PART OF A NEW EXCLUSIVE FDA COMPLIANCE LEARNING COMMUNITY
Practical CONTENT Packages and Webinars
Christine Park, Quality Expert, discusses Management Review & FDA Inspections in her latest video clip.
New - Conducting Effective Management Reviews Content Package
Developed by Christine Park
This 6 item content package, authored by Christine Park, quality expert, includes a 2 ½ hour webinar recording and powerpoint training presentation, SOP template, powerpoint training presentation template which enables you to prepare your own Management Review presentation and an excel spreadsheet document which enables you to easily track management review items. READ MORE...
Other Christine Park Products
Supplier Management Content Package
More Than SOPs: Defining the Documentation Lifecycle That Best Fits Your Organization
New Webinars
- Complaint Handling & FDA Reporting Requirements
- Five Ways to Improve Your CAPA Process - Recording
- Auditing Drug GMP Part 211 - NEW RECORDING
- Introduction to Validation and Its Documentation - NEW RECORDING
- What New Employees Need to Know About GMP Pharmaceutical Regulations and FDA Enforcement - NEW RECORDING
- Conducting Effective Batch Record Reviews - NEW RECORDING
- New - GMP WEBINARS ON DEMAND
New - CAPA Procedures & Tools Content Package
Written by a former FDA Investigator with 20+ years experience, this incredible content package includes 22 procedural templates, SOPs, excel spreadsheets and tools which will help you identify, categorize, organize, investigate and effectively execute CAPAs. Read More - Click Here
NEW Supplier Management Content Package
This package contains three (3) content elements in effectively managing suppliers, including:
1. Supplier Quality Agreement Master Template
2. Supplier Gap Assessment Matrix (Excel spreadsheet document)
3. Supplier Prioritization Tool (software tool)
The Supplier Prioritization tool is designed to assist in prioritizing supplier management activities based on a quantitative approach to risk.
Consideration is given to business, risk, product regulatory classification, as well as supplier performance criteria.
It is based on a simple 1,2,3 ranking for each of the identified criteria.
It is customizable to fit any quality system requirement, whether IVD Pharmaceutical, biotech or med device.
Author Christine Park provides a video capability demonstration of the tool. enKap VP Terri Melvin introduces Christine, and she begins the presentation by showing 2012 Supplier-related Warning Letter trends - Click Here to view
MORE NEW CONTENT PACKAGES...
➢Design C
ontrols MEGA Content Package NEW
Written by a former FDA investigator with 20+ years experience and includes16 Documents, SOP, Auditing Checklist, 10 Work Instruction Documents, PowerPoint training presentation for implementing design controls in your company. 224 pages of information, including 161 pages of work instruction documents. Read More - Click Here...
➢Change Control CONTENT Package
UPDATED WITH NEW DOCUMENTS FROM A FORMER FDA INVESTIGATOR! A one hour webinar recording, two (2) PDF PowerPoint presentations, audit checklist, two (2) SOPs, FAQ and Answers document and template Read More - Click Here...
Complimentary Excerpts - click here
Watch John Stromp, the author of our e-textbook - industry's definitive "how to" training and auditing resource on Part 211 Regulations) speak about various topics...click here for more information and complimentary excerpts
To view more video clips click here
Events
Blog Posts
Reviewing Process Trend Data for Complaint Investigations
Our Author, Rob Packard of Medical Device Academy (http://medicaldeviceacademy.com) writes in this excerpt from his article, 7 Ways to Investigate Complaints when Devices are not Returned, “Regulators also look for trends associated with a specific lot of raw materials or manufacturing operator. To perform this type of analysis, I recommend a systematic approach. The tool I recommend…
ContinuePosted by Terri Melvin on June 19, 2013 at 8:30am
AUDITOR QUALITY TRAINING: 5 MISTAKES TO AVOID
Our author Rob Packard of Medical Device Academy writes, “How can you evaluate an auditor's ability to interview people, take notes, follow audit trails and manage their time? The most common solution is to require that the auditor "shadow" a more experienced auditor several times, and then the trainee will be "shadowed"…
ContinuePosted by Glenn Melvin on June 9, 2013 at 8:00pm
7 WAYS TO INVESTIGATE COMPLAINTS WHEN DEVICES ARE NOT RETURNED
In this excerpt, our author, Rob Packard of Medical Device Academy (http://medicaldeviceacademy.com)
writes, “An OEM may receive dozens or even hundreds of product quality complaints each year. During a recall, there may be hundreds of complaints per month. One of the greatest challenges in complaint handling is making sure that you have done enough when you are unable to…
ContinuePosted by Terri Melvin on June 7, 2013 at 10:30am
13 TIPS FOR LEARNING NEW REGULATIONS
1. Read and re-read the draft regulations now
2. Read blogs and discussion threads related to the draft regulations for the next couple of months
3. Take a webinar on the draft regulations
4. Draft a plan for revising procedures (date) and updating technical documentation (date)
5. Get management approval for…
ContinuePosted by Terri Melvin on June 5, 2013 at 9:30am
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