FREE* 8-Hour GMP QMS Training - Select Month

GMP Boot Camps, GMP Publications & The Auditing Group, offering Free* Monthly GMP Training includes Registration Fee, Digital Certificate & e-Workbook (Download Brochure)

Quantity Discounts Automatically Apply:
5 Seat - 5%   10 Seat - 10%   25 Seat - 15%   50 Seat - 20%   100 Seat - 25%

NOTE: Each person must register with a unique email address to get credit. 
for more information go to GMP Boot Camp website Terms.  See www.gmpbootcamps.com for Free GMP QMS Training Schedule.

Check dates at www.gmpbootcamps.com

• GMP Basics 101 (See Agenda Below)
• US FDA Title 21 CFR Part 11 Electronic Records; Electronic Signatures with Scope and Application 2003 - FDA Interpretation of Part 11.
• US FDA Title 21 CFR Parts 210/211 Good Manufacturing Practices - The regulations containing the minimum CGMPs for methods, facilities or controls to be used for manufacture, processing, packing, or holding of a drug product.
• US FDA Title 21 CFR Part 820 Quality Management Systems Regulation The controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices.

*The $29.95 Registration Fee includes, Registration, e-Workbook & e-Certificate and to prevents 'No-Shows' registrants.
The Webinar SME's Time is FREE.

(See: http://www.gmpbootcamps.com).

If you have a discount code, apply discount code below.

Agenda: GMP 101 Basics:

• Risk Management
• The GMP Focus & The GMP Lifestyle,
• Roles & Responsibilities • Agency Inspections & Observations
• Quality Terminology & Quality Controls The QMS Basics:
• QMS Basics
• CAPA - Corrective & Preventive Actions;
• Non-Conformance - Materials;
• Change Control - Documentation, Engineering, Production & Distribution;
• Deviations - Deviation Management Essentials;
• Out of Specifications / Out of Trend - Management of OOS & OOT;
• Complaints - Receipt, Assessments & Remediation/Resolution;
• Recalls - The Plan & Process;
• Product Traceability;
• Audit - Internal, Agency, Customers & External Audits;
• Vendors, Suppliers & Contractors - Quality Agreements;

The Meetings - Management & Quality Meetings; GMP 11 General Orders:

1. Write Procedures;
2. Follow Procedures;
3. Documentation;
4. Validation;
5. Build Facilities;
6. Maintaining Facilities;
7. Competency;
8. Good Housekeeping Practices;
9. Control for Quality;
10. Audit for Compliance;
11. Prepare for Battle - Recall & Traceability Audits;

21 CFR Part 11 Electronic Records; Electronic Signatures:

• Basic Overview; Definitions & Classifications;

• Part 11.10 Sections a) - k)

• (a) Validation
• (b) Copies of Records
• (c) Protection of Records
• (d) Limit Access
• (e) Audit Trails
• (f) Forced Steps
• (g) Authority Checks
• (h) Device Qualifications
• (i) Training
• (j) Procedures
• (k) Documentation

• ALCOA and GAMP

• MS Excel

*Conditions: Must meet 7-hour min. to receive Certificates. 'Eye's On' verification in place to ensure registrants viewed Webinars. Attendees must login using unique email address to obtain a certificate.

NOTE: REGISTRAT NAME DOES NOT HAVE TO MATCH NAME ON CREDIT CARD!