Western blotting: principles, applications, and techniques
30 min
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34 min
1. Principles of SOPs and hierarchy of documents- Dr. Laura Brown
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38 min
2. Effective SOP writing- Dr. Laura Brown
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47 min
3. Using process mapping, forms and templates for the production of SOPs- Mr. Gareth Turner
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41 min
4. Electronic SOPs vs. paper - compliance with FDA CFR 21 part 11- Mr. Gareth Turner
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43 min
5. Use of technology and document management systems for SOPs- Mr. Gareth Turner
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29 min
6. SOPs and improving business performance to meet GXP- Mr. Richard Winning
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33 min
7. Procedural assessments of SOPs to ensure SOPs are logical and meet GXP requirements- Mrs. Susan Ollier
- Mrs. Pam Wilson
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39 min
8. SOPs and outsourcing- Dr. Laura Brown
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27 min
9. SOP training- Dr. Laura Brown
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30 min
10. SOPs as part of a quality centric process system- Dr. Laura Brown
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18 min
11. SOPs as part of the quality system- Mr. Steve Nicholas
Printable Handouts
Navigable Slide Index
- Introduction
- Speaker's CV in short
- This talk will cover
- In days gone by
- Moving with the times
- Using EDMS without CFR 21
- Paper and technology
- Reasons for investing in technology
- What to expect from your EDMS
- Paper records
- Electronic record advantages
- Now CFR 21 part 11 kicks in
- Electronic records (1)
- Electronic records (2)
- Electronic records (3)
- Electronic records (4)
- Electronic record systems
- Electronic signatures (1)
- Electronic signature background
- Electronic signatures (2)
- Digital signatures
- Biometric signatures
- Electronic records and signatures
- eSignatures & records EDMS considerations (1)
- eSignatures & records EDMS considerations (2)
- Other considerations
- A thought for the future
- Summary
Topics Covered
- Before technology
- From paper to technology
- EDMS development
- EDMS functionality
- Functionality and CFR 21
- Record retention
- Electronic signatures
Links
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Talk Citation
Turner, G. (2013, June 13). Electronic SOPs vs. paper - compliance with FDA CFR 21 part 11 [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved November 4, 2025, from https://doi.org/10.69645/BGLE4237.Export Citation (RIS)
Publication History
- Published on June 13, 2013
Financial Disclosures
- Mr. Gareth Turner has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.
Electronic SOPs vs. paper - compliance with FDA CFR 21 part 11
Published on June 13, 2013
41 min
