PDA Science Advisory Board Candidate Skills & Experience Survey

Question Title

* 9. Please indicate your highest level of leadership experience

Individual Contributor

Technical Manager

Department head/group Manager

Senior Manager

Other (please specify)

Question Title

* 10. PDA Membership (number of years)

Question Title

* 11. PDA Activities (mark all that you have participated in)

Advisory board member

Board of Directors member

Interest Group leader

Technical Report Team member

Conference Planning Committee member

Course/Workshop Instructor

Regulatory Commenting team

Chapter Officer

Other (please specify)

Question Title

* 12. Please check if you have been involved with the following Associations. (Check all that apply)

PhRMA

Bio

EFPIA

IFPMA

USP

European Pharmacopeia

PiC/S

ICH

DIA

RX-360

BioPhorum

Combination Products Coalition

IPEC

APEC

PPTA

ISPE

Question Title

* 13. Other Association Affiliation(s), Regulatory Agencies and Activities

Topic Area Experience Self-Ranking
Please indicate your level of knowledge or experience in the topic listed below.
NOTE: the topic listed refers to general experience/proficiency (not necessarily ATMP) unless specifically stated.

The criteria for ranking High/Medium/Low is:

High (H) – Extensive experience/expertise based that could be used to lead efforts on a topic independently – high level of competency/proficiency in this area and recognized expert in this area inside/outside of PDA

Medium (M) - Current or past experience/expertise providing an amount of competence to participate or contribute, but not sufficient to be an independent leader – solid level of competence/proficiency in this area

Low (L) - Cursory or no experience/expertise in the topic – low level of competence/proficiency in the area and not able to contribute significantly to advancing this area

	H	M	L
Controls and qualification of raw materials and starting materials (scope of GMP)	Controls and qualification of raw materials and starting materials (scope of GMP) H	Controls and qualification of raw materials and starting materials (scope of GMP) M	Controls and qualification of raw materials and starting materials (scope of GMP) L
Facilities design/qualification	Facilities design/qualification H	Facilities design/qualification M	Facilities design/qualification L
Production equipment	Production equipment H	Production equipment M	Production equipment L
Microbial contamination control strategy and risk assessment	Microbial contamination control strategy and risk assessment H	Microbial contamination control strategy and risk assessment M	Microbial contamination control strategy and risk assessment L
Drug product manufacture/ testing	Drug product manufacture/ testing H	Drug product manufacture/ testing M	Drug product manufacture/ testing L
Drug substance/starting material manufacturing	Drug substance/starting material manufacturing H	Drug substance/starting material manufacturing M	Drug substance/starting material manufacturing L
Stability studies and expiry date assignments	Stability studies and expiry date assignments H	Stability studies and expiry date assignments M	Stability studies and expiry date assignments L
Reference standard qualification and lifecycle management	Reference standard qualification and lifecycle management H	Reference standard qualification and lifecycle management M	Reference standard qualification and lifecycle management L
Quality standards	Quality standards H	Quality standards M	Quality standards L
Product and process comparability studies	Product and process comparability studies H	Product and process comparability studies M	Product and process comparability studies L
Technology transfer	Technology transfer H	Technology transfer M	Technology transfer L
Quality system adaptation (appropriate quality to oversee the real-time process)	Quality system adaptation (appropriate quality to oversee the real-time process) H	Quality system adaptation (appropriate quality to oversee the real-time process) M	Quality system adaptation (appropriate quality to oversee the real-time process) L
Process Validation (Stages 1-3)	Process Validation (Stages 1-3) H	Process Validation (Stages 1-3) M	Process Validation (Stages 1-3) L
Process control strategy (CQA, CPP, KPP, etc.)	Process control strategy (CQA, CPP, KPP, etc.) H	Process control strategy (CQA, CPP, KPP, etc.) M	Process control strategy (CQA, CPP, KPP, etc.) L
Supply chain	Supply chain H	Supply chain M	Supply chain L
Material and lot disposition	Material and lot disposition H	Material and lot disposition M	Material and lot disposition L
Trace-/trackability of material and product (COC/COI)	Trace-/trackability of material and product (COC/COI) H	Trace-/trackability of material and product (COC/COI) M	Trace-/trackability of material and product (COC/COI) L
Data management (e-batch records, translational data, etc.)	Data management (e-batch records, translational data, etc.) H	Data management (e-batch records, translational data, etc.) M	Data management (e-batch records, translational data, etc.) L
Regulatory intelligence/surveillance	Regulatory intelligence/surveillance H	Regulatory intelligence/surveillance M	Regulatory intelligence/surveillance L
Marketing strategy development and execution	Marketing strategy development and execution H	Marketing strategy development and execution M	Marketing strategy development and execution L
Vaccines	Vaccines H	Vaccines M	Vaccines L
Drug Product (sterile)	Drug Product (sterile) H	Drug Product (sterile) M	Drug Product (sterile) L
Drug Product (non-sterile)	Drug Product (non-sterile) H	Drug Product (non-sterile) M	Drug Product (non-sterile) L
Standards Development	Standards Development H	Standards Development M	Standards Development L
Combination Products	Combination Products H	Combination Products M	Combination Products L
Low bioburden manufacturing	Low bioburden manufacturing H	Low bioburden manufacturing M	Low bioburden manufacturing L
Sterile and aseptic manufacturing	Sterile and aseptic manufacturing H	Sterile and aseptic manufacturing M	Sterile and aseptic manufacturing L
Isolators	Isolators H	Isolators M	Isolators L
Blow-Fill-Seal	Blow-Fill-Seal H	Blow-Fill-Seal M	Blow-Fill-Seal L
Single use manufacturing equipment	Single use manufacturing equipment H	Single use manufacturing equipment M	Single use manufacturing equipment L
Solid dosage forms	Solid dosage forms H	Solid dosage forms M	Solid dosage forms L
Lyophilization	Lyophilization H	Lyophilization M	Lyophilization L
Validation, qualification	Validation, qualification H	Validation, qualification M	Validation, qualification L
Container closure integrity	Container closure integrity H	Container closure integrity M	Container closure integrity L
Visual Inspection	Visual Inspection H	Visual Inspection M	Visual Inspection L
QC testing: chemical, physical	QC testing: chemical, physical H	QC testing: chemical, physical M	QC testing: chemical, physical L
QC testing: microbiological (incl. rapid)	QC testing: microbiological (incl. rapid) H	QC testing: microbiological (incl. rapid) M	QC testing: microbiological (incl. rapid) L
Sterility testing (incl. facilities)	Sterility testing (incl. facilities) H	Sterility testing (incl. facilities) M	Sterility testing (incl. facilities) L
Environmental monitoring	Environmental monitoring H	Environmental monitoring M	Environmental monitoring L
PAT, QbD, statistics, analytics	PAT, QbD, statistics, analytics H	PAT, QbD, statistics, analytics M	PAT, QbD, statistics, analytics L
QA, cGMP, QMS	QA, cGMP, QMS H	QA, cGMP, QMS M	QA, cGMP, QMS L
Risk Management	Risk Management H	Risk Management M	Risk Management L
Elastomers	Elastomers H	Elastomers M	Elastomers L
Medical devices	Medical devices H	Medical devices M	Medical devices L
Glass	Glass H	Glass M	Glass L
Primary packaging materials	Primary packaging materials H	Primary packaging materials M	Primary packaging materials L
Shipping, cold chain	Shipping, cold chain H	Shipping, cold chain M	Shipping, cold chain L
Software design/validation	Software design/validation H	Software design/validation M	Software design/validation L

Controls and qualification of raw materials and starting materials (scope of GMP)

Controls and qualification of raw materials and starting materials (scope of GMP) H

Controls and qualification of raw materials and starting materials (scope of GMP) M

Controls and qualification of raw materials and starting materials (scope of GMP) L

Facilities design/qualification

Facilities design/qualification H

Facilities design/qualification M

Facilities design/qualification L

Production equipment

Production equipment H

Production equipment M

Production equipment L

Microbial contamination control strategy and risk assessment

Microbial contamination control strategy and risk assessment H

Microbial contamination control strategy and risk assessment M

Microbial contamination control strategy and risk assessment L

Drug product manufacture/ testing

Drug product manufacture/ testing H

Drug product manufacture/ testing M

Drug product manufacture/ testing L

Drug substance/starting material manufacturing

Drug substance/starting material manufacturing H

Drug substance/starting material manufacturing M

Drug substance/starting material manufacturing L

Stability studies and expiry date assignments

Stability studies and expiry date assignments H

Stability studies and expiry date assignments M

Stability studies and expiry date assignments L

Reference standard qualification and lifecycle management

Reference standard qualification and lifecycle management H

Reference standard qualification and lifecycle management M

Reference standard qualification and lifecycle management L

Quality standards

Quality standards H

Quality standards M

Quality standards L

Product and process comparability studies

Product and process comparability studies H

Product and process comparability studies M

Product and process comparability studies L

Technology transfer

Technology transfer H

Technology transfer M

Technology transfer L

Quality system adaptation (appropriate quality to oversee the real-time process)

Quality system adaptation (appropriate quality to oversee the real-time process) H

Quality system adaptation (appropriate quality to oversee the real-time process) M

Quality system adaptation (appropriate quality to oversee the real-time process) L

Process Validation (Stages 1-3)

Process Validation (Stages 1-3) H

Process Validation (Stages 1-3) M

Process Validation (Stages 1-3) L

Process control strategy (CQA, CPP, KPP, etc.)

Process control strategy (CQA, CPP, KPP, etc.) H

Process control strategy (CQA, CPP, KPP, etc.) M

Process control strategy (CQA, CPP, KPP, etc.) L

Supply chain

Supply chain H

Supply chain M

Supply chain L

Material and lot disposition

Material and lot disposition H

Material and lot disposition M

Material and lot disposition L

Trace-/trackability of material and product (COC/COI)

Trace-/trackability of material and product (COC/COI) H

Trace-/trackability of material and product (COC/COI) M

Trace-/trackability of material and product (COC/COI) L

Data management (e-batch records, translational data, etc.)

Data management (e-batch records, translational data, etc.) H

Data management (e-batch records, translational data, etc.) M

Data management (e-batch records, translational data, etc.) L

Regulatory intelligence/surveillance

Regulatory intelligence/surveillance H

Regulatory intelligence/surveillance M

Regulatory intelligence/surveillance L

Marketing strategy development and execution

Marketing strategy development and execution H

Marketing strategy development and execution M

Marketing strategy development and execution L

Vaccines

Vaccines H

Vaccines M

Vaccines L

Drug Product (sterile)

Drug Product (sterile) H

Drug Product (sterile) M

Drug Product (sterile) L

Drug Product (non-sterile)

Drug Product (non-sterile) H

Drug Product (non-sterile) M

Drug Product (non-sterile) L

Standards Development

Standards Development H

Standards Development M

Standards Development L

Combination Products

Combination Products H

Combination Products M

Combination Products L

Low bioburden manufacturing

Low bioburden manufacturing H

Low bioburden manufacturing M

Low bioburden manufacturing L

Sterile and aseptic manufacturing

Sterile and aseptic manufacturing H

Sterile and aseptic manufacturing M

Sterile and aseptic manufacturing L

Isolators

Isolators H

Isolators M

Isolators L

Blow-Fill-Seal

Blow-Fill-Seal H

Blow-Fill-Seal M

Blow-Fill-Seal L

Single use manufacturing equipment

Single use manufacturing equipment H

Single use manufacturing equipment M

Single use manufacturing equipment L

Solid dosage forms

Solid dosage forms H

Solid dosage forms M

Solid dosage forms L

Lyophilization

Lyophilization H

Lyophilization M

Lyophilization L

Validation, qualification

Validation, qualification H

Validation, qualification M

Validation, qualification L

Container closure integrity

Container closure integrity H

Container closure integrity M

Container closure integrity L

Visual Inspection

Visual Inspection H

Visual Inspection M

Visual Inspection L

QC testing: chemical, physical

QC testing: chemical, physical H

QC testing: chemical, physical M

QC testing: chemical, physical L

QC testing: microbiological (incl. rapid)

QC testing: microbiological (incl. rapid) H

QC testing: microbiological (incl. rapid) M

QC testing: microbiological (incl. rapid) L

Sterility testing (incl. facilities)

Sterility testing (incl. facilities) H

Sterility testing (incl. facilities) M

Sterility testing (incl. facilities) L

Environmental monitoring

Environmental monitoring H

Environmental monitoring M

Environmental monitoring L

PAT, QbD, statistics, analytics

PAT, QbD, statistics, analytics H

PAT, QbD, statistics, analytics M

PAT, QbD, statistics, analytics L

QA, cGMP, QMS

QA, cGMP, QMS H

QA, cGMP, QMS M

QA, cGMP, QMS L

Risk Management

Risk Management H

Risk Management M

Risk Management L

Elastomers

Elastomers H

Elastomers M

Elastomers L

Medical devices

Medical devices H

Medical devices M

Medical devices L

Glass

Glass H

Glass M

Glass L

Primary packaging materials

Primary packaging materials H

Primary packaging materials M

Primary packaging materials L

Shipping, cold chain

Shipping, cold chain H

Shipping, cold chain M

Shipping, cold chain L

Software design/validation

Software design/validation H

Software design/validation M

Software design/validation L

PDA Science Advisory Board Candidate Skills & Experience Survey

Question Title

* 1. Salutation

Question Title

* 2. First Name

Question Title

* 3. Last Name

Question Title

* 4. Title

Question Title

* 5. Company

Question Title

* 6. Email Address

Question Title

* 7. Geographic Location

Question Title

* 8. Employment type

Question Title

* 9. Please indicate your highest level of leadership experience

Question Title

* 10. PDA Membership (number of years)

Question Title

* 11. PDA Activities (mark all that you have participated in)

Question Title

* 12. Please check if you have been involved with the following Associations. (Check all that apply)

Question Title

* 13. Other Association Affiliation(s), Regulatory Agencies and Activities

Question Title

* 14. Topic Area Experience Ranking

Question Title

* 15. Which PDA IGs have you joined? (Check all that apply)