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FDA Documentation and IT Regulatory Compliance Training - Live Webinars, Recordings & CDs

3
/ Mar
Wednesday-2021
Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance
- Speaker: David Nettleton
- Product ID: 701582
- Duration: 75 Min
* Per Attendee
$229
$229

10
/ Mar
Wednesday-2021
How to Prepare a Standard Operating Procedure (SOP)?
- Speaker: Dr. Afsaneh Motamed Khorasani
- Product ID: 705131
- Duration: 60 Min
* Per Attendee
$229
$229

9
/ Apr
Friday-2021
Annual Current Good Manufacturing Practices (cGMP) Training
- Speaker: Kelly Thomas
- Product ID: 705422
- Duration: 60 Min
* Per Attendee
$199
$199
Recorded/CD

Good Documentation Guideline (Chapter <1029> USP)
- Speaker: Dr. Afsaneh Motamed Khorasani
- Product ID: 705130
- Duration: 60 Min
CD/Recorded
$299
$299
Recorded/CD

Good Documentation Practice and Record Keeping Regulations (FDA & EMA)
- Speaker: Dr. Afsaneh Motamed Khorasani
- Product ID: 705583
- Duration: 60 Min
CD/Recorded
$299
$299
Recorded/CD

Implementation and Management of GMP Data Integrity
- Speaker: Danielle DeLucy
- Product ID: 705029
- Duration: 90 Min
CD/Recorded
$299
$299
Recorded/CD

Technical Writing for the Pharmaceutical, Medical Device and Biotech Industries
- Speaker: Joy McElroy
- Product ID: 704531
- Duration: 120 Min
CD/Recorded
$349
$349
Recorded/CD

Japan: Regulatory Compliance Requirements for Life Science Products
- Speaker: Robert J Russell
- Product ID: 702979
- Duration: 90 Min
CD/Recorded
$299
$299
Recorded/CD

Risk-Based Software V&V Per U.S. FDA, IEC 62304, GAMP 5 (Reg.) and ISO 14971
- Speaker: John E Lincoln
- Product ID: 701461
- Duration: 60 Min
CD/Recorded
$399
$399
Recorded/CD

4-Hr Virtual Training: How to Respond to an FDA Investigation
- Speaker: Joy McElroy
- Product ID: 704549
- Duration: 4 hrs
CD/Recorded
$449
$449
Recorded/CD

CDISC Mapping 5: ADAM Models - ADSL, BDS and ADAE
- Speaker: Sunil Gupta
- Product ID: 704316
- Duration: 90 Min
CD/Recorded
$299
$299
Recorded/CD

Avoid Documentation 'Time Bombs'
- Speaker: John E Lincoln
- Product ID: 701407
- Duration: 60 Min
CD/Recorded
$299
$299
Recorded/CD

CDISC Mapping 4: SDTMs and ADAMs Examples (80%/20% Mapping Rule)
- Speaker: Sunil Gupta
- Product ID: 704313
- Duration: 90 Min
CD/Recorded
$299
$299
Recorded/CD

CDISC Mapping 3: Compare and Contrast SDTM and ADaM Steps
- Speaker: Sunil Gupta
- Product ID: 704302
- Duration: 90 Min
CD/Recorded
$299
$299
Recorded/CD

21 CFR 11 Compliance for Excel Spreadsheet
- Speaker: Angela Bazigos
- Product ID: 702450
- Duration: 90 Min
CD/Recorded
$249
$249
Recorded/CD

New and Expected Guidance’s on Data Standards and Electronic Submissions for Drugs and Medical Products
- Speaker: Angela Bazigos
- Product ID: 704529
- Duration: 90 Min
CD/Recorded
$249
$249
Recorded/CD

Software Validation and its 11 Key Documents
- Speaker: John E Lincoln
- Product ID: 703097
- Duration: 90 Min
CD/Recorded
$299
$299
Recorded/CD

CDISC Mapping 2: ODM, MindMaps and References
- Speaker: Sunil Gupta
- Product ID: 704208
- Duration: 90 Min
CD/Recorded
$299
$299
Recorded/CD

Writing Effective and compliant SOPs
- Speaker: Angela Bazigos
- Product ID: 702429
- Duration: 90 Min
CD/Recorded
$299
$299
Recorded/CD

The Most Serious FDA 483s - How to Avoid Them
- Speaker: John E Lincoln
- Product ID: 702766
- Duration: 90 Min
CD/Recorded
$299
$299
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